Distress- the 6th vital sign for cancer patients?

A third or more of cancer patients experience significant psychological distress following their diagnosis. Yet a much smaller proportion receives any psychosocial services.

Cancer-Care-for-the-Whole-Patient-Meeting-Psychosocial-Health-NeedsThis situation is counter to recommendations from a number of sources, including the US Institute of Medicine report, Care of the Whole Patient, Meeting Psychosocial Health Needs. The gap between the proportion of patients experiencing distress and those getting services has led to widespread calls for implementing routine screening for distress. The assumption is that the breakdown between being distressed and getting services is patients getting identified and being referred to appropriate services.

There have been intense national and international campaigns by professional organizations first to recommend implementation of screening and then to mandate it as a condition of accreditation of cancer care settings. Increasingly, campaigns are organized around the slogan “distress is the sixth vital sign.” Promoters have sufficient political clout to get the slogan into the titles of articles in scientific journals, often with leaders of the field of psycho-oncology lending support as co-authors.

Holland, J. C., & Bultz, B. D. (2007). The NCCN guideline for distress management: a case for making distress the sixth vital sign. Journal of the National Comprehensive Cancer Network, 5(1), 3-7.

Bultz, B. D., & Johansen, C. (2011). Screening for distress, the 6th vital sign: where are we, and where are we going? PsychoOncology, 20(6), 569-57.

Watson, M., & Bultz, B. D. (2010). Distress, the 6th vital sign in cancer care. Psycho-oncologie, 4(3), 159-163.

The push to make distress accepted as the sixth vital sign for cancer patients is modeled after efforts to get pain designated as the fifth vital sign for general medical patients. In the late 1980s, it was recognized that pain management was grossly inadequate, with many patients’ pain going undetected and untreated. Pain was designated the fifth vital sign in general medical settings, with guidelines set for assessment and improved referral and treatment. These guidelines were first simply recommendations, but they grew to be mandated, with performance goals and quality of care indicators established to monitor their implementation in particular settings.

What is distress? Maybe not what you think

distressDistress was originally defined narrowly in terms of stress and anxiety and depressive symptoms. Early screening recommendations were for quick assessment with a distress thermometer modeled after the simple pain rating scale adopted in the campaign for pain as the fifth vital sign. Efforts were made to validate distress thermometers in terms of their equivalence to longer self-report measures of anxiety and depression, and in turn, interview-based measures of psychiatric disorder. Ratings on a distress thermometer were not seen as a substitute for longer assessments, but rather as a screening for whether longer assessments were needed. Patients who screened above a cutpoint on a distress thermometer would be identified for further assessment.

“Distress” was the preferred term, rather than stress or anxiety or depressive symptoms, because it was viewed as more neutral and not necessarily indicating that someone who wanted services had a psychiatric disorder. It was believed that many cancer patients did not seek services out of fear of being stigmatized and this vague term might avoid that raising that barrier to treatment.

However, the definition has now been extended to include a much broader range of needs and concerns. The widely cited definition of the NCCN of distress is

An unpleasant emotional experience of a psychological, social and/or spiritual nature which extends on a continuum from normal feelings of vulnerability, sadness and fears to disabling problems  such as depression, anxiety, panic, social isolation and spiritual crisis.

The emphasis is still on quick screening, but the distress thermometer is typically supplemented with a checklist of common problems. Particular items vary across recommendations for screening, but the checklist is meant to be a brief supplement to the distress thermometer. Canadians who have taken the lead in promoting distress as the sixth vital sign recommend a Modified Problem Checklist (PCL).

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This list contains the 7 most common practical problems in our  settings (accommodation, transportation, parking, drug coverage, work/school, income/finances, and groceries); and 13 psychosocial problems (burden to others, worry about family/friends, talking with family, talking with medical team, family conflict, changes  in appearance; alcohol/drugs, smoking, coping, sexuality, spirituality, treatment decisions and  sleep). Participants indicate the presence or absence of each problem in the preceding week.

Despite the range of problems being assessed, the assumption is still that the predominant form of services that patients will seek as a result of being screened is some form of psychological counseling or psychotherapy.

Interventions usually assume one of four common forms: psychoeducation, cognitive-behavioural training (group or individual), group supportive therapy, and individual supportive therapy.

Support by professional organizations for screening of distress is quite widespread. Well-organized proponents exercise their political clout in making expression of enthusiasm for screening an obligatory condition for publishing in psycho-oncology journals. Dissenting critics and embarrassing data can be summarily sandbagged. Even when embarrassing data makes it through the review process, authors may be surprised to discover that their articles are accompanied by disparaging commentaries, to which they have not been offered an opportunity to respond. I have been publishing for over thirty years, and I have never before encountered the level of bullying that I have seen with papers concerning screening.

screeningYet, promotion of implementing routine screening for distress is based only on consensus of like-minded professionals, not the systematic evaluation of evidence that medical screening generally requires. Screening tests are common in medicine. The standard criteria for adopting a recommendation for screening is that it can be shown to improve patient outcomes beyond simply making available to patients and their providers the resources that are accessed by screening.

It is not sufficient that screening address a serious problem, it must also lead to improved outcomes. For instance, it is now recognized that although prostate cancer is a common and threatening disease, routine screening for prostate cancer of men without symptoms is likely to lead to overtreatment and side effects incontinence and loss of a sexual functioning, without any improvement in overall survival. Campaigns to promote  prostate specific antigen (PSA) testing have largely been discontinued. More generally, Choosing Wisely committees are systematically reevaluating the evidence for common forms of screening and withdrawing recommendations. Some well established screening procedures are losing their recommendation.

We undertook a systematic review of the literature concerning screening for distress and failed to find sufficient evidence to recommend it.

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Because of the lack of evidence of beneficial effects of screening cancer patients for distress, it is premature to recommend or mandate implementation of routine screening.

Other reviews have come to more favorable evaluations of screening,  arrived at by including nonrandomized trials or trials that chose number of referrals being made is a surrogate outcome in place of distress being reduced. However, for a patient getting referred to experience reduced distress, a complex pathway has to be crossed, starting with acceptance and completion of the referral and including receiving appropriate treatment at an appropriate level of intensity and frequency. Referrals, particularly when they are to outside the cancer’s care setting, are notoriously black holes. There are a few systematic data concerning the fate of referrals, but the general consensus is that many, perhaps most are not completed.

My colleagues and I also noted that the professional recommendations for screening have not been developed according to the standard procedures for making such recommendations. Development of professional guidelines is supposed to follow an orderly process of

  • Assembling a diverse and representative group of relevant stakeholders,
  • Systematically reviewing the literature with transparency in search criteria and method of synthesis and interpretation.
  • Publication of preliminary recommendations for public comment.
  • Revision of preliminary recommendations taking into account feedback.

In contrast, recommendations for screening have simply been released by professional groups assembled on the basis of previously known loyalty to the conclusion and with inattention to the lack of evidence showing that screening would improve outcomes. Notably missing from the “consensus” groups recommending screening are patients, frontline clinicians who will have to implement screening, and professionals from the community who would have to receive and evaluate referrals, notably primary-care physicians in most countries.

Nonetheless, the push for routine screening of cancer patients for psychological distress continues to gain momentum, with goals being set in many settings for the minimal proportion of cancer patients who must be screened.

The slogan “distress is the sixth vital sign” is not a testable empirical statement of the order of “depression is a significant risk factor for cardiac mortality.” Rather, it is best evaluated in terms of the use of terms, particularly “vital sign” and whether adopting slogan improves patient outcomes. Let us look at the notion of vital sign and then at the outcome of efforts to adopt pain has the fifth vital sign.

What is a vital sign?

According to Wikipedia

vital_signs_bot_image_blkVital signs are measures of various physiological statistics, often taken by health professionals, in order to assess the most basic body functions. Vital signs are an essential part of a case presentation. The act of taking vital signs normally entails recording body temperature, pulse rate (or heart rate), blood pressure, and respiratory rate, but may also include other measurements. Vital signs often vary by age.

In an excellent discussion of vital signs, Lucy Hornstein states

If someone other than the patient can’t see, hear, palpate, percuss, or measure it, it’s a symptom. Anything that can be perceived by someone else is a sign.

And

Vital signs are measured…and yield numeric results. Normal ranges are defined; values that fall outside those normal ranges are described with specific words (eg, bradycardia, tachypnea, hypothermia, hypertension).

A cough is a sign, but a headache is a symptom. Not that headaches are less “real,” they are just different.

With the standard definitions, pain cannot be a vital sign, only a symptom. The labeling of pain as a vital sign is metaphoric involves twisting the definition of a sign.

Something I will note now, but come back to later in the blog: patients cannot really argue against results of assessment of a vital sign. If repeated blood pressure readings indicate dystolic pressure above established cutoff, it is not left for the patient to argue “no, I do not have hypertension.” The notion is that a vital sign is objective and not subject to validation by patient self-report, although what to do about the vital sign may be interpreted in terms of other data about the patient, some of it from self-report. The point is that calling a measurement a “vital sign” claims particular authority for the results.

There have been numerous proposals for designating other vital signs in need of routine assessment and recording in medical records. These include (here I have extended the list from Wikipedia):

Pain as the fifth vital sign

Okay, so it is only metaphorically that pain can be considered a fifth vital sign. But what was nonetheless accomplished by designating it so in terms of improving its management? What can be learned that can be applied to designating distress as the sixth vital sign?

pain buttonThe pain-as-fifth-vital-sign (P5VS) campaign simply started with publicizing of high levels of untreated pain in medical populations, which in turn led to the consensus statements and mandated screening, similar to what is now occurring with declaring distress as the sixth vital sign.

1992. US Agency for Healthcare Quality Research (AHQR), issued guidelines documenting that half of surgical patients did not receive adequate post-surgical medication. The guidelines declared patients had a “right” to adequate pain measurement.

1995. American Pain Society (APS) issued a landmark consensus statement with guidelines for a quality improvement approach towards the treatment of acute and cancer pain [10], expanding upon its 1989 guidelines [11] for the treatment of pain. In his Presidential Address, Dr. James Campbell presented the idea of evaluating pain as a vital sign.

1998. The Veterans Health Administration (VHA) launched a national  P5VS initiative to pain thermometerimprove pain management for its patients, starting with documentation in the electronic medical record of assessment of patients’ self-report of pain.  It required use of a Numeric Rating Scale (NRS) in all clinical encounters.

P5VS campaigns were based on professional consensus, not appraisal of best evidence. When studies were later conducted, results did not demonstrate that the fifth vital sign campaign improved patient outcomes.

The title of a study of 300 consecutive patients before the start of the VA initiative and 300 afterwards says it all:

Measuring Pain as the 5th Vital Sign Does Not Improve Quality of Pain Management

The study examined 7 process indicators of quality of pain management fail to identify any improvement in

  • Subjective provider assessment (49.3% before versus 48.7% after).
  • Occurrence of a pain exam (26.3% versus 26.0%).
  • Orders to assess pain (11.7% versus 8.3%).
  • New pain medication prescribed (8.7% versus 11.0%)
  • Change in existing pain medication prescription (6.7%, 4.3%)
  • Other pain treatment (11.7% versus 13.7%).
  • Recording of follow-up plans (10.0%, 8.7%).

The initiative required that “patients indicating a score of four or about on a pain scale should receive comprehensive pain assessment and prompt intervention . . ’’

In a subsample of patients who reported substantial pain:

  • 22% had no attention to pain documented in the medical record of the visit which they reported.
  • 52% received no new therapy for pain at that visit.
  • 27% had no further assessment documented.

Our investigation of the P5VS…initiative at a single VA site has shown the routine documentation of pain levels, even with system-wide support and broad-based provider education, was ineffective in improving the quality-of-care.

carly-simon-havent-got-time-for-the-pain-1974

Carly Simon – Haven’t Got Time for the Pain

What was going wrong? It appears that front line clinicians making the pain assessments lacked the time or skills to take effective action. Pain assessments were typically conducted in encounters for which there are other reasons for the visit. Furthermore, pain assessments were collected outside of a clinical interaction in which the context or history could be discussed, which could likely lead to invalid ratings. When patients were asked only to rate current pain, it was unknown whether they took into account how much the pain bothered them, whether it was acute or chronic, or whether it reflected any change from past levels, all meaningful considerations. Other clinicians in the system either did not receive the ratings in a timely fashion or lacked the context to interpret the ratings.

Other studies [1, 2] similarly demonstrated that the P5VS campaign was by itself ineffective:

One potential reason for the insensitivity of routine pain screening in these studies is that all were conducted in outpatient primary and specialty care settings where chronic persistent or intermittent pain is much more common than acute pain. Routine pain screening that focuses on pain intensity “now” may not be sufficiently sensitive to detect important chronic pain that occurs episodically or varies with activity. In the VA primary care, the vast majority of pain problems are longstanding in nature, so sensitivity for chronic pain is important for any pain screening strategy in this setting.

The mandate that unrelieved pain must be addressed soon led to ineffective, inappropriate treatment that was not based on proper assessment. There was an increase in diagnostic tests that only confirmed existence of pain that was difficult to treat, notably chronic back pain. In the decade after the campaign to reduce pain was launched, costs of treating chronic back pain escalated without any demonstrated improvement in patient outcomes.

The guidelines had been promulgated with claims that addiction to opiates prescribed for acute pain was rare. But the evidence for that was only a brief 1980 letter in the New England Journal of Medicine indicating only four instances in treatment of 12,000 patients.

The campaign to improve pain control using routine ratings had an effect unanticipated by its proponents.

Dispensing opioids has almost doubled according to National Health and Nutrition Examination Survey data indicating that from 1988 to 1994 a total of 3.2% of Americans reported using opioids for pain, whereas from 2005 to 2008 a total of 5.7% reported use.

This significant increase has been associated with serious consequences, including an estimated 40 deaths per day due to prescription opioids.

Put simply

Improving pain care may require attention to all aspects of pain management, not just screening.

The pain as the fifth vital sign campaign involved mandated assessment of pain with a simple numerical scale at every clinical encounter, regardless of the reason for visit. The rating was typically obtained in the absence of any effort to talk to patients or to examine them in an effort to determine what were likely the multiple sources of their pain, its history, and their goals. Indeed, collecting these simple ratings may have become a substitute for having such discussions. The number on the rating scale came to characterize the patient for purposes of clinical decision-making, and may have led to overtreatment including escalating prescription of pain medication.

Is a good idea to consider distress the sixth vital sign?

Like pain, distress is not a vital sign by the conventional definition of the term. Yet to label it as such suggests that there is some sort of objective procedure involved in collecting ratings on a distress thermometer from patients.

Generally ignored in the promotion of screening is that most patients who indicate distress above established thresholds do not wish to receive a psychosocial service that they are not already receiving. Current guidelines for screening do not have a requirement of asking patients where they have any need for services. Instead, their response to the distress thermometer is used to tell them that they need intervention, with an emphasis on counseling.

When asked directly, most distressed patients reject the need for psychosocial services that they are not already getting, often outside the cancer center.  A rather typical study found that 14% definitely and an additional 29% maybe wanted to talk with a professional about their problems. Patients variously report

  • Already receiving services.
  • Believing they can solve the problems themselves.
  • Concentrating on the treating their physical illness takes precedence over receiving psychosocial and supportive services.
  • Services being offered to them are not needed, timely, or what they preferred.

A heightened score on a distress thermometer is a poor indication of whether patients are interested in receiving services that are listed on a screening sheet. Most do not want to receive a service, but most receiving services are not distressed. Think about it, looking at the problems listed on the screening form above. Many of the problems would be endorsed without patients having a heightened distress score. This poses for the dilemma for any interpretation of a score on a distress thermometer as if it were a vital sign.

Overall, thinking about distress as the sixth vital sign creates the illusion that a score on a distress thermometer is an authoritative, objective standalone indicator, much like a blood pressure reading. Actually, scores on a distress thermometer need to be discussed and interpreted. If distress is taken too seriously as the sixth vital sign, there is a risk that patients who do not meet the cut off for clinically significant distress will be denied an opportunity to discuss the problems that they might otherwise seek.

My colleagues and I undertook a study where we used results of screening for distress to attempt to recruit a sample of patients for an intervention trial evaluating problem-solving therapy as a way of reducing distress. It proved to be a discouragingly inefficient process.

  • We screened 970 cancer patients, of whom 423 were distressed, and, of these, 215 indicated a need for services. However, only 36 (4%) consented to participate in the intervention study.
  • 51% of the distressed patients reported having no need for psychosocial services and an additional 25% were already receiving services for their needs.
  • Overall, we had to screen 27 patients in order to recruit a single patient, with 17 hours of time required for each patient recruited.

Consider could have been accomplished if these 17 hours of were used instead to talk to patients who had indicated they wanted to talk to someone about their problems.

Designating distress as the sixth vital sign suggest false objectivity and validity to a procedure that has not demonstrated improvement in patient outcomes. It is an advertising slogan that is likely to prove ineffective and misdirect resources, just as the P5VS did.

 

 

Category: cancer, distress, evidence-supported, mental health care, palliative care, screening | Tagged , , , , | Leave a comment

Is dying a mental health issue?

Should a dying patient talking to a psychiatrist be diagnosed with adjustment disorder related to death?

 Dare we ask: Could impending death not be sufficiently psychologically distressing for patients to routinely benefit from psychotherapy?

2Presentation1Patients aware that they are dying often wish to talk to someone about their predicament. Should psychiatrists and psychologists be the first line professionals for such discussions? After all, aren’t many dying patients experiencing substantial psychological distress? Specialty mental health professionals would have the skills to differentially diagnose this distress and offer appropriate targeted treatment. And what about their ability to identify and address issues of suicidality?

Or should discussions be left to clergy and pastoral counselors, especially for patients of faith?

Raising these questions could easily get us into philosophical and spiritual issues where we might feel excused from having to bring in evidence. But a relatively large-scale and well-designed study has given us a relevant answer. Maybe not the answer that the investigators hoped to find and they probably will not like my further interpretation. And, sure, it is only one randomized trial, but results seem to speak exceptionally clearly about a number of issues.

The study was negative, but demonstrates just how much a well-designed negative trial can reveal.

The study appeared in the prestigious Lancet Oncology (Journal impact factor [JIF] = 21.12), along with a commentary.

Chochinov, H. M., Kristjanson, L. J., Breitbart, W., McClement, S., Hack, T. F., Hassard, T., & Harlos, M. (2011). Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. The Lancet Oncology, 12(8), 753-762.

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The randomized trial was conducted with a large sample (441) of patients recruited fromhospices and home-based palliative care in Australia, Canada, and the United States. Investigators compared their preferred intervention, dignity therapy (165 patients), to two comparison/ conditions – standard palliative care (140 patients) and client-centered care (136 patients).

Stated goal

This study represents the first randomized control trial of Dignity Therapy. We set out to determine if this novel psychotherapeutic approach would significantly outperform standard care, or Client Centered Care…on various measures of psychological, existential and spiritual distress.

Primary outcome

The primary outcome was distress, which sounds simple enough, but it was measured 23 different ways. No one variable was designated as the primary outcome for the purposes of evaluating the effectiveness or ineffectiveness of dignity therapy would be judged. There are also 22 different secondary outcomes, single items evaluating patients’ experience participating in the intervention.

The three conditions

Dignity Therapy provides patients with life-limiting illnesses an opportunity to speak about things that matter most to them. The conversations are recorded and transcribed to provide the basis for a document that patients can bequeath to individuals of their choosing.

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Patients were shown the Dignity Therapy question framework [see Table to the left] and asked to consider what they might wish to speak about during their Dignity Therapy session(s); this initial introduction to, and explanation of Dignity Therapy took about 30 minutes. Within a few days, or as soon as a second meeting could be arranged, the therapist used the question framework to help elicit the patient’s recollections, hopes, wishes for loved ones; lessons learned and things they wanted remembered by those they were about to leave behind. Dignity Therapy is flexible enough to accommodate participant preferences and choices regarding content, but the ethos of questioning targets those things that might enhance a sense of meaning, purpose, continued sense of self, and overall sense of dignity. All Dignity Therapy sessions were audio-taped; these sessions usually took about 60 minutes. Upon completion, the audio-recording was transcribed verbatim and the transcript edited, to provide a clear and readable narrative. This transcript or `generativity document’ was returned to the patient..,[and] read to them in its entirety to ensure that no errors of omission or commission needed to be addressed (this final session usually took about 30 minutes). .. The final version of the generativity document was then given to the patient, to be passed along to a designated recipient of their choosing.

dignity therapy tell themTherapists for the dignity therapy were psychologists, psychiatrists, or experienced palliative care nurses.

Generativity is a key concept in dignity therapy.

Generativity or the ability to guide the next generation, encompasses how patients might find strength or comfort in knowing that they will leave behind something lasing and transcendent after death.

Some readers may recognize the similarity of the investigators’ concept of generativity and Erik Erikson’s life stage of generativity versus stagnation.

In Standard Palliative Care patients had access to a full range of palliative care support services, including specialist palliative care physicians and nurses with expertise pain and symptom management, social workers, clergy, and mental health professionals.

There were not, however, any components of standard palliative care directly comparable to the dignity therapy.

Client Centred Care was a supportive psychotherapeutic approach, in which the therapist guides patients through discussions focusing on here and now issues. These might include their illness and symptoms and what is being done to address symptom distress. However, in order to keep this condition distinct from dignity therapy, the therapist did not encourage discussion of issues of meaning and purpose. If these topics came up, the therapist redirected the conversation back to illness-related issues.

The therapist for client-centred care was a research nurse.

What was found.

nothingNo evidence was found that that dignity therapy reduced distress across 22 different measures of distress, including overall scores and subscale scores from an array of measures.

The 23 items representing secondary outcomes had only a few differences between the three groups, no more than would be expected by chance. We should be careful about the statistically significant results that were obtained, but perhaps patients were expressing appreciation that they had been randomized to the specialized treatment, as well as having the document to leave for family members. With only five items dignity therapy was found to be superior to both standard palliative care and client-centred care.

The investigators’ interpretation.

Despite the beneficial effects of Dignity Therapy, its ability to mitigate outright distress, such as depression, desire for death or suicidality, has yet to be proven. However, there is currently ample evidence supporting its clinical application for patients nearing death, as a means of enhancing their end-of-life experience.

While floor effects precluded our ability to demonstrate significant differences across study arms, our secondary outcomes revealed substantive benefits of Dignity Therapy. Using a post-study survey, patients who received Dignity Therapy were significantly more likely to report benefits, in terms of finding it helpful, improving their quality of life, their sense of dignity; changing how their family might see or appreciate them, and deeming it helpful to their family, compared to the other study arms.

The investigators were obviously passionate about their intervention and looked exhaustively for evidence of the efficacy of dignity therapy. They really did not find any.

What I liked about this trial.

I like the unusually large sample size and the inclusion of two different control/comparison groups the allowed answering different kinds of questions. This is certainly not an underpowered pilot study being passed off as a full randomized trial. The Standard Palliative Care group allowed determination of whether dignity therapy offered anything beyond routine care. And a reader definitely gets the sense that routine care in this study was neither no care or inadequate care, as it is with so many studies. The Client Centered Care condition pitted the investigators’ preferred intervention against a lower intensity intervention that provides support, but without an element that the investigators considered key to their intervention.

The intervention followed a structured standardized protocol. Standardized training was provided, along with group supervision and review of transcripts of recordings of actual sessions to ensure fidelity of delivery.

The study recruited from a variety of settings and had an excellent uptake from patients who were offered an opportunity to participate.

Patients were randomized with the investigators blinded as to group assignment.

What I like less

The investigators administered a full battery of potential outcome measures including total and subscale scores of

The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale, Patient Dignity Inventory, Hospital Anxiety and Depression Scale, items from the Structured Interview for Symptoms and Concerns, Quality of Life Scale, and modified Edmonton Symptom Assessment Scale.

These measures tend to be moderately to highly correlated and so having this battery available for assessment of outcome represents considerable redundancy. The investigators not designating one or two measures as the primary outcomes set the stage for the investigators selecting a primary outcome after they knew the results, risking confirmatory bias and capitalization on chance.

The investigators had to contend with substantial lots of patients, not unexpectedly, because these are palliative care patients, but they did not avail themselves of a number of ways to provide estimates for the missing data and so analyses were not intention-to-treat.

This little reason to believe that this changed the results, however, because of the floor effect that they noted.

I did not like the positive spin put on the null findings of this trial. Confirmatory bias was clear in the abstract and extended to the discussion. The structured abstract conceded a lack of effect on distress, but cherry picked positive findings to emphasize out of an overall null set of secondary outcomes. In the interpretation section of the structured abstract offered:

Although the ability of dignity therapy to mitigate outright distress, such as depression, desire for death or suicidality, has yet to be proven, its benefits in terms of self-reported end-of-life experiences support its clinical application for patients nearing death.

The laudatory accompanying commentary.

Thecommentary on this article is an embarrassingly obvious attempt to spin and refute results the commentator did not want to accept.

Commentaries in peer-reviewed journals are typically not rigorously peer-reviewed. They tend to be written with an agenda, by reviewers who nominated themselves to write them. I have previously blogged about an unusual commentary in which the writer sought to destroy the credibility of an article she did not like, despite it having been accepted for publication. Most often, however, commentaries are laudatory and written with an awareness that the authors of the commentaries can get away with praise that would not survive peer-reviewed.

The commentator sought damage control in the face of an utter lack of significant findings. She tried to undermine the validity of an RCT for studying psychosocial interventions. It is true that clinical trials restrict participation to patients with sufficient cognitive intactness, but so do any talk therapies. Her criticism that the sample was not heterogeneous and representative was contradicted by demonstration most patients who were approached participated. Differences in baseline variables are a threat to the validity of results of an RCT, but one of the strengths of such a design is that it serves to minimize such differences. And the commentator gave no evidence that baseline differences between groups undermined the validity of this particular trial.

The commentator raised issues about the standardization of the treatment across settings, but ignored the efforts made to ensure fidelity of delivery. The commentator further ignored the efforts of the investigators to control for nonspecific factors by inclusion of both a standard care and a client centred/comparison control condition. Maybe the richness of standard care precludes finding any effect for the addition of dignity therapy, but that is a valuable finding. It sng that a specialized dignity therapy is not needed. Finally, the commentator’s suggestion that outcomes may not adequately measured is bewildering in the face of the investigators administering a battery of 22 measures for primary outcome and 23 measures for secondary outcome. What does she think is missing?

Given the effort to positively spin solidly null findings in both the article and the commentary, one has to ask under what conditions the investigators and commentator with and willing to concede that this is not a promising line of treatment development?

Why I consider this study important.

Although one does not make a definitive judgment on the basis of a single trial, there is little here to encourage further consideration of dignity therapy as an evidence-based therapy.

The investigators made the testable assumption that end-of-life is a time of considerable psychological distress. They designed an intervention to be delivered by mental health professionals to relieve that distress. They evaluated their intervention in an adequately powered randomized trial, but failed to find any evidence of an effect. The most likely reason is that this large representative sample of palliative care patients was simply not distressed enough to benefit from a mental health intervention.

One could argue that the intervention was not sufficiently intense or mental health oriented, but low baseline distress would preclude a more intense intervention succeeding. There is a floor effect going on, as the investigators recognize.

Basic pilot work would have revealed the surprisingly low levels of distress in this population. A specialty mental health oriented intervention may not be warranted with patients who are not specifically selected for distress. And furthermore, the minority of palliative care patients who show clinically significant distress may not benefit from an intervention like this. They probably would require something more intensive and specifically aimed at reducing distress, with evidence of the intervention having worked in other populations.

But the assumption that cancer patients suffer substantial psychological distress, and patients in palliative care particularly so, is so well entrenched that it is difficult to challenge. Certainly, if investigators applied for a NIH grant and stated that end-of-life is not a time of great psychological distress, they would have risked a low priority for funding.

Giving dying patients a chance to talk: Going from a feature of routine care to a treatment

The investigators failed to find that their structured intervention, dignity therapy offered benefits beyond routine care or a client centred care that had key elements removed: therapists for this condition were not allowed to discuss meaning or purpose.

Suppose investigators had found a therapy mainly provided by psychiatrists and psychologists yielded substantial reductions in distress. These findings would have reinforced existing views of palliative care patients as having high levels of distress. They would further have demonstrated the inadequacy of both good quality routine care and a client centred care modeled after what pastoral counselors offer in providing dying patients with opportunities to discuss their “recollections, hopes, wishes for loved ones; lessons learned and things they wanted remembered by those they were about to leave behind.”

Dignity therapy would be on its way to being an evidence-based treatment with demonstrated ability to reduce significant psychological distress.

And this would propel our moving what had been a feature of routine care to a formal treatment that is of necessity a billable procedure that ultimately requires a diagnosis psychiatrist and psychologist do not provide treatment without diagnosis of disorder. But with what diagnosis?

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The low levels of psychological distress do not indicate the likelihood of substantial psychiatric disorder in this population. There is already a suitable diagnostic category that is loose and limited in its validity, but that serves administrative purposes, adjustment disorder. Mental health professionals seeking to document the diagnosis of patients being treated with dignity therapy, but lacking any other formal psychiatric disorder, could always bill for adjustment reaction related to death. That mental health professionals wanted to treat the patient and the patient wanted treatment would in itself be an indication of distress and clinically significant impairment. And the cause of the disorder the dignity therapy targeted is impending death.

Making a diagnosis of adjustment disorder often is a successful resolution of acute compensation crisis of mental health professionals. They are not offered treatment in the absence of the diagnosis, they are treating adjustment disorder.

Psychiatrists and psychologists offer treatment in “sessions” that are of necessity of limited duration typically half hour to 50 minutes. They do so with a certain time pressure. They follow  schedules allowing only small time intervals between patients and no running over, even if the discussion is intense and productive.

In contrast, pastoral counselors do not require diagnoses for what they provide to patients. While there may be heavy demands on their time, they do not typically operate with rigidly timed “sessions” and will stay with the patient as long as needed, within practical limits. This particular trial of dignity therapy fails to find any evidence that what they do is less efficacious than a psychologist or psychiatrist.

Much of the content of dignity therapy will differ according to the religious faith of patients. It would seem that pastoral counselors could address these issues with greater authority and knowledge.

As an agnostic, I approached working with pastoral counselors in cancer care with skepticism as to whether they would take advantage of patients’ dying days to win them back to their faith. I never saw any of that happen. Rather, all the pastoral counselors I have ever seen have a deep respect for patients’ level of commitment to their faith – or lack thereof. I would characterize what they do is provide a presence for patients’ talking about things that matter to them, nondirectively guiding the conversation forward, but without imposition of their own views.

How do we evaluate what pastoral counselors do? If what they provide is not considered treatment, there is no issue of whether it is evidence-based treatment. It does not require that patients be distressed in order to be eligible for a discussion, nor that the distress be resolved for the discussion to be “successful.”

An example from primary care illustrates some of the “crisis” of medical care in the United States and in many countries that extends to cancer care, dignity therapy would be implemented.

Click to enlarge http://minnesota.cbslocal.com/2012/10/19/questions-can-trigger-split-visit-charge-at-docs-office/

Click to enlarge
http://minnesota.cbslocal.com/2012/10/19/questions-can-trigger-split-visit-charge-at-docs-office/

Image Methods Of Psychosocial Intervention 2 4 13-1As detailed in a CBS news story, a woman sought a physical examination from her primary care physician, after not receiving regular care for some time. She came prepared with a long list of health questions for which she would seek answers in her appointment. The physician obtained reimbursement from insurance for the physical by billing for all of the specific tests and procedures that had been done. However, he billed the woman by the minute for the discussion. A commentator in the news segment discussing this said, in effect, ‘physicians get paid for doing procedures, not for whether they solve problems and not for talking about it.”

Cancer care is expensive, which means lucrative for both for-profit and not-for-profit settings that can obtain reimbursement. There is increasing emphasis on procedures that are billable to third-party payers and for efficient use of providers’ time.   Provision of basic emotional support and time for patients discussing their concerns are endangered features of routine cancer care. But we should be careful about efforts to preserve these features by making them billable mental health procedures. That entails an inevitable need for a diagnosis and for rationing talk time, restricting it to those patients having a mental health related disorder.

More generally, psychotherapy intervention trials in cancer care do not typically attract patients with clinically significant distress in great numbers. Across trials, only about a third of the patients are clinically distressed. That is about the same as what you find in primary care medical population waiting rooms.

Correspondingly, RCTs of psychotherapy for cancer patients often failed to show a benefit because the patient samples that are recruited are overall insufficiently distressed. Why are the patients there, then?

It is likely that with the increasing scarcity of talk time in routine care, patients are simply seeking a safe place where they will be listened to, and can express and reflect on their feelings, not necessarily solve problems or reduce distress. That can be an entirely valid goal in itself. But problems arise when these discussions are of necessity provided as treatment with mental health professionals. Issues of cost effectiveness and efficacy arise, for which formal evidence is required. And such treatment is typically in short supply, with long waiting lists.

This RCT of dignity therapy came about because a  psychiatrist passionate about what he provides for palliative care patients developed and evaluated a structured mental health treatment. Maybe it is not all bad that the trial was negative. We now have a greater chance of preserving supportive elements of palliative care, including time for patients to talk about their concerns, and can hold off rationing them.

 

Category: cancer, death and dying, evidence-supported, palliative care, psychotherapy | Tagged , , , , | Leave a comment

Neurobalm: the pseudo-neuroscience of couples therapy

soothingsyrup1Special thanks to Professor Keith Laws, blogger at LawsDystopiaBlog and especially the pseudonymous Neurocritic for their helpful comments. But any excesses or inaccuracies are entirely my own responsibility.

 

You may be more able to debunk bad neuroscience than you think.

In my last blog post, I began critically examining whether emotionally focused couples therapy (EFT) could be said to sooth the brains of wives who had received it.

Claims were made in a peer-reviewed article available here and amplified in a University of Ottawa press release that EFT was a particularly potent form of couples therapy. An fMRI study supposedly demonstrated how EFT changed the way the brain encoded threatening situations.

True love creates resilience, turning off fear and pain in the brain

OTTAWA, May 1, 2014— New research led by Dr. Sue Johnson of the University of Ottawa’s School of Psychology confirms that those with a truly felt loving connection to their partner seem to be calmer, stronger and more resilient to stress and threat.

In the first part of the study, which was recently published in PLOS ONE, couples learned how to reach for their lover and ask for what they need in a “Hold Me Tight” conversation. They learned the secrets of emotional responsiveness and connection.

The second part of the study, summarized here, focused on how this also changed their brain. It compared the activation of the female partner’s brain when a signal was given that an electric shock was pending before and after the “Hold Me Tight” conversation.

The experiment explored three different conditions. In the first, the subject lay alone in a scanner knowing that when she saw a red X on a screen in front of her face there was a 20% chance she would receive a shock to her ankles. In the second, a male stranger held her hand throughout the same procedure. In the third, her partner held her hand. Subjects also pressed a screen after each shock to rate how painful they perceived it to be.

Before the “Hold Me Tight” conversation, even when the female partner was holding her mate’s hand, her brain became very activated by the threat of the shock — especially in areas such as the inferior frontal gyrus, anterior insula, frontal operculum and orbitofrontal cortex, where fear is controlled. These are all areas that process alarm responses. Subjects also rated the shock as painful under all conditions.

However, after the partners were guided through intense bonding conversations (a structured therapy titled Emotionally Focused Couple Therapy or EFT), the brain activation and reported level of pain changed —under one condition. While the shock was again described as painful in the alone and in the stranger hand holding conditions (albeit with some small change compared to before), the shock was described as merely uncomfortable when the husband offered his hand. Even more interesting, in the husband hand-holding condition, the subject’s brain remained calm with minimal activation in the face of threat.

These results support the effectiveness of EFT and its ability to shape secure bonding. The physiological effects are exactly what one would expect from more secure bonding. This study also adds to the evidence that attachment bonds and their soothing impact are a key part of adult romantic love. Results shed new light on other positive findings on secure attachment in adults, suggesting the mechanisms by which safe haven contact fosters more stability and less reactivity to threat.

You can find my succinct deconstruction of the press release here.

I invite you to carefully read the article or my last blog post and this one. This shouldhold me tight prepare you to detect some important signs this press release is utter nonsense, designed to mislead and falsely impress clinicians to whom EFT workshops and trainings are marketed. For instance, where in the procedures described in the PLOS One article is there any indication of the “Hold Me Tight” conversation? But that is just the start of the nonsense.

The PLOS One article ends with the claim that this “experiment” was conducted with a rigor comparable to a randomized clinical trial. Reading the article or these blog posts, you should also be able to see that this claim too is utter nonsense.

In my last blog post, I showed a lack of compelling evidence that EFT was better than any other couples treatment. To the extent to which EFT has been evaluated at all, the studies are quite small and all supervised by promoters of EFT. Couples in the EFT studies are recruited to be less martially dissatisfied than in other couples therapy research, and there is some evidence that improvement in marital functioning does not persist after therapy ends.

I called attention to the neuroscientist Neurocritic’s caution against expecting fMRI studies to reveal much about the process or effectiveness of psychotherapy that we do not know already.

Of course, we should expect some effects of psychotherapy to be apparent in pre-post therapy fMRI studies. But we should also expect the same of bowling or watching a TV series for equivalent amount of time. Are we really getting much more than what we what we can observe in couples’ behavior or what they report after therapy to what we can find with an fMRI? And without a comparison group, studies are not particularly revealing.

The larger problem looming in the background is authors intentionally or unintentionally intimidating readers with glib interpretations of neuroscience. Few readers feel confident in their ability to interpret such claims, especially the therapists to whom author Susan Johnson’s workshops are promoted.

This blog post could surprise you.

Maybe it will reassure you that you possess basic critical faculties with which you can debunk the journal article –if you are willing to commit the time and energy to reading and rereading it with skepticism.

I would settle, however, for leaving you thoroughly confused and skeptical about the claims in the PLOS One article. There are lots of things that do not make sense and that should be confusing if you think about them.

Confusion is a healthy reaction, particularly if the alternative is gullibility and being persuaded by pseudoscience.

I begin by ignoring that this was specifically an fMRI study.  Instead, I will look at some numbers and details of the study that you can readily discover. Maybe you would have had to look some things up on the Internet, but many of you could replicate my efforts.

In the text below, I have inserted some numbers in brackets. If you click on them, you will be taken to a secondary blog site where there are some further explanations.

The 23 wives for whom data were reported are in unrepresentative and highly select subsample of the 666 wives in couples expressing an interest in response to advertisements for the study.

With such a small number of participants–

  •  Including or excluding one or two participants can change results [1]. There is some evidence this could have occurred after initial results were known [2].
  • Any positive significant findings are likely to be false, and of necessity, significant findings will be large in magnitude, even when false positives [3].

The sample was restricted to couples experiencing only mild to moderate marital dissatisfaction. So, the study sample was less dissatisfied with their marriages, i.e.,  not comparable to those recruited by other research groups for couples intervention studies.

Given the selection procedure, it was impossible for the authors to obtain a sample of couples with the mean levels of marital dissatisfaction that they reported for baseline assessments.

They stated that they recruited couples with the criteria that their marital dissatisfactionyour sample sizes are small initially be between 80-96 on the DAS. They then report that initial mean DAS score was 81.2 (SD=14.0). Impossible. [4]

Yup, and this throws into doubt all the other results that are reported, especially when they find they need to explain results that did not occur as expected in differences between pre and post EFT fMRI, but only in a complex interaction between pre/post fMRI and initial DAS scores.

Couples therapy was continued until some vaguely defined clinical goal had been achieved.  None of the details were presented that one would expect a scientific paper for how it was decided that this was enough therapy.

We were not told who decided, by what criteria, or with what interrater reliability the judgments were made. We do know Susan Johnson, CEO of the nonprofit and profit-making companies promoting EFT supervised all therapy and the study.

Basically, Dr. Johnson was probably able to prolong the therapy and the follow-up fMRI assessment until she believed that the wives responses would make the therapy look good. And with no further follow-up, she implies that “how the brain processes threat” had been changed without any evidence that whether changes in fMRI persisted or were transient.

This might be fine for the pseudo-magic of a workshop presentation, but is unacceptable for a peer-reviewed article for which readers are supposed to be able to arrive at an independent judgment. And far removed from the experimental control of a clinical trial in which timing of follow up assessments are fixed.

Randomized clinical trials take this kind of control away from investigators and put it into the design and the phenomenon being studied so that maybe investigators can be proved incorrect.

The amount of therapy that these wives received (M= 22-9, range =13-35) was substantially more what was provided in past EFT outcome studies. Whatever therapeutic gains were observed in the sample could not be expected to generalize to past studies. [5]

Despite the therapy that they had received and despite the low levels of marital dissatisfaction with which they had begun, the average couple finishing the study still qualified for entering it. [6]

There is no explanation given why only wives data are presented. No theoretical or clinical rationale is given for not studying husbands or presenting their data as well [7]

A great deal is made of whether particular results are statistically significant or not. However, keep in mind that there was a very small sample size and the seemingly sharp distinction between significant and nonsignificant is arbitrary. Certainly, the size of most differences between results characterized as significant versus nonsignificant is not itself statistically significant. [8]

And, we will see, much is being made of small differences that did not occur for all wives, only those initially with the lowest marital satisfaction.

The number of statistical tests the conducted was many times number of women in the study. The authors do not indicate all the analyses they conducted and selectively reported a subset of the analyses conducted, but there was considerable room for capitalizing on chance.

cherrypickingMultiple statistical tests in  a small sample without adjustment for there being so many tests is a common complaint about small fMRI studies, but this study is a particularly bad example. Happy cherrypicking!

The article and Johnson’s promotional materials make much of differences that were observed from fMRI data collected before and after therapy. But the article never reports results for actually testing these differences.This is an important discovery. Let’s stop and explore it.

The article leads off its presentation of the fMRI results with

The omnibus test of EFT and handholding on all voxels activated in the original Coan et al. handholding study indicated a significant interaction between EFT, handholding and DAS, F (2, 72.6) = 3.6, p= .03 (Alone x EFT x DAS b= 10.3, SE =3.7; Stranger x EFT x DAS b = 2.5, SE =3.3).

What is oddly missing here is any test of the simple interaction between EFT (before versus after therapy) and handholding, i.e., EFT x handholding. The authors do not tell us whether the overall effects on hand holding (partner versus alone versus stranger) were different from before versus after completion of EFT (partner versus alone versus stranger), but that is the difference they want to discuss.

Basically, the authors only report interactions between EFT and handholding as qualified by level of initial marital satisfaction.

So? The authors proposed the simple hypothesis that receiving EFT will affect fMRI results in a situation involving threat of pain. They are about to do a very large number of multiple statistical tests and they want to reassure the reader that they are not capitalizing on chance.

For reassurance, they need an interaction between EFT and handholding in the omnibus test. Apparently they did not get it. What they end up doing is going back and forth between whatever few statistical tests are significant from the well over 100 tests that they conducted for pre-/post-fMRI findings. When most of those tests proved nonsignificant they went to a more complex interaction between fMRI results qualified by wives’ level of marital satisfaction.

NThis  is a classic fishing expedition with a high probability that many of the fish should be thrown back as false positives. And the authors do not even have the fishing license that they hoped  significant omnibus results would have provided.

The article makes repeated references to following up and replicating an earlier study by one of the authors, Jim Coan. That study involved only 16 women selected for higher marital satisfaction, so much so, they were called “supercouples” in press coverage of the study. You can find Neurocritic’s critique of that study here.

The levels of marital satisfaction for the two small samples were discontinuous with each other—any couples eligible for one would be disqualified from the other by a wide margin. Most of the general population of married people would fall in between these two studies in  level of marital satisfaction. And any reference, as these authors make, to findings for women with low marital satisfaction in the Coan study are bunk. The highly select sample in the Coan study did not have any women with low marital satisfaction.

The two  samples are very different, but neither study presented data in a way that allowed direct comparison with the other. Both studies departed from transparent, conventional presentation of data. Maybe the results for the original Coan study were weak as well and were simply covered up. That is suggested in the Neurocritic blog post.

But the problem is worse than that. The authors claim that they are preselected the regions of interest (ROIs) based on the results that Coan obtained with his sample of 16 women. If you take the trouble to examine Table 1 from this article and compare it to Coan’s results, you will see that some of the areas of the brain they are examining did not produce significant results in Coan’s study. More evidence of a fishing expedition.

It is apparent that the authors changed their hypotheses after seeing the data. They did not expect changes in the stranger condition and scrambled to explain these results. If you jump to the Discussion section concerning fMRI results for the stranger condition, you get a lot of amazing post-hoc gobbledygook as the authors try to justify the results they obtained. They should simply have admitted that their hypothesis was not confirmed.

j figure 2.pone.0079314.g002

Figure 2. Point estimates of percent signal change graphed as a function of EFT (pre vs. post) by handholding (alone, stranger, partner) and DAS score.

The graphic representations in Figures 2 and 4 were produced by throwing away two thirds of the available data [9].  Yup. Each line represents results for two wives. It is unclear what interpretation is possible, except that it appears that after throwing away all this data, differences between pre- and post-therapy were not apparent for the group that started with higher marital satisfaction. It is nearly flat in the partner condition, which the authors consider so important.

We do not want to make too much of these graphs because they are based on so few wives. But they do seem to suggest that not much was happening for women with higher marital satisfaction to begin with. And this may be particularly true for the responses when they were holding the hand of their partner. Yikes!

aPLOS Johnson EFT-1

Click to enlarge

In looking at the graphical representations of self-report data in figure 1 and the fMRI data in figures 3 and 5, pay particular attention to the bracketing +/- zones, not just the heights of the bar graphs. Some of the brackets overlap or nearly so and you can see that small differences are being discussed.

And, oh, the neuroscience….

It is helpful to know something about fMRI studies to go much further in evaluating this one. But I can provide you with some light weaponry for dispensing with common nonsense.

First, beware of multiple statistical tests from small samples. The authors reassure us that their omnibus test reduced that threat, but they did not report relevant results and they probably did not obtain the results they needed for reassurance. And the results they expected for the omnibus test would not have been much reassurance anyway, they would still be largely capitalizing on chance. The authors also claim that they were testing regions of interest (ROIs), but if you take a careful look, they were testing other regions of the brain and they generally did not replicate much of Coan’s findings from his small study.

new phrenologySecond, beware of suggestions that particular complex mental functions are localized in single regions of the brain so that a difference for that mental function can be inferred from a specific finding for that region. The tendency of investigators to lapse into such claims has been labeled the new phrenology, phrenology being the 19th century pseudoscience of bumps. The authors of this study lead us into this trap when they attempt to explain in the discussion section findings they did not expect.

Third, beware of glib interpretations that a particular region of the brain is activated in terms of meaning that certain mental processes are occurring. It is often hard to tell what activation means. More activity can mean that more mental activity is occurring or it can mean the same mental activity requires more effort.

Fourth, beware of investigators claiming that changes in activation observed in fMRI data represent changes in the structure of the brain or mental processes (in this case, the authors’ claim that processing of threat had been changed). They are simply changes in activity and they may or may not persist and they may or may not be compensated by other changes. Keep in mind the brain is complex and function is interconnected.

Overall, the MRI results were weak, inconsistent, and obscured by the authors’ failure to report simple pre-post differences in any straightforward fashion. And what is presented really does not allow direct comparison between the earlier Coan study and the present one.

The authors started with the simple hypothesis that fMRI assessments conducted before and after EFT would show changes in wives’ response to threat of pain relative to whether there hand was being held by their partner, a stranger, or no one. Results were inconsistent and the authors were left struggling with findings that after a course of EFT, among other things, the wives were more comfortable with their hands been held by a stranger and less comfortable being alone. And that overall, results that they expected to be simply a result of the wives getting EFT actually were limited to wives who got EFT, but who had the lowest marital satisfaction to begin with.

We could continue our analysis by getting into the specific areas of brain functioning for which significant results were or were not obtained. That is dubious business because so many of the results are likely to be due to chance. If we nonetheless continue, we have to confront post-hoc gobbledygook efforts to explain results like

In the substantia nigra/red nucleus, threat-related activity was generally greater during stranger than partner handholding, F (1, 47.4) = 6.5, p = .01. In the vmPFC, left NAcc, left pallidum, right insula, right pallidum, and right planum polare, main effects of EFT revealed general decreases from pre- to post- therapy in threat activation, regardless of whose hand was held, all Fs (1, 41.1 to 58.6) > 3.9, all ps < .05.

Okay, now we started talking about seemingly serious neuroscience and fMRIs and you are confused. But you ought to be confused. Even a neuroscientist would be confused, because the authors are not providing a transparent presentation of their findings, only a lot of razzle dazzle designed to shock and awe, not really inform.

Magneto, the BS-fighting superhero summoned by Neurocritic

Magneto, the BS-fighting superhero summoned by Neurocritic

In an earlier blog post concerning the PLOS One study, Neurocritic detected nonsense and announced that Magneto, a BS-fighting superhero was being summoned. But even mighty Magneto was thwarted by the confused presentation of ambiguous results and the absence of knowledge of what other results had been examined but were suppressed because they did not support the story the authors wanted to tell.

I’m not sure that I understand this formulation, or that a dissociation between behavioral self-report and dACC activity warrants a reinterpretation of EFT’s therapeutic effects. Ultimately, I don’t feel like a BS-fighting superhero either, because it’s not clear whether Magneto has effectively corrected the misperceptions and overinterpretations that have arisen from this fMRI research.

Some of you may be old enough to recall Ronald Reagan doing advertisements for Generalconfused-man Electric on television. He would always end with “Progress is our most important product.” We have been trying to make sense of neuroscience data being inappropriately used to promote psychotherapy,and have had to  deal with all the confusion, contradictory results, and outright cover-up in an article in PLOS One. To paraphrase Reagan, “Confusion is our most important product.” If you are not confused, you don’t sufficiently grasp what is being done in the PLOS One article and the press coverage and promotional video.

Category: Couples therapy, neuroscience, Uncategorized | Tagged , , , , , | 3 Comments

Soothing psychotherapists’ brains with NeuroBalm

Promoters of Emotionally Focused Psychotherapy offer sciencey claims with undeclared conflicts of interest, cherry picked evidence, and bad science.

The temptation exists for researchers and clinicians to search for the strongest and most provocative version of their knowledge, which will create greatest publicity. The appeal is great; oversell and over-dramatize the result and attention will follow. — Jay Lebow, Editor, Family Process

amygdalaPity the poor therapists. They want to do the best for their clients. They are required to get CE credits for licensure and renewal. But how do they choose their CE courses? With workshop promoters hawking approved courses in thought field therapy and somatic experiencing therapies, therapists can understand that professional organizations’ approval is no guarantee that what they will learn is evidence- supported or that it will mostly help, rather than hurt their clients.

Worse, few therapists have the research background minimally necessary to interpret the sometimes wild claims made promoters of workshops. They are unprepared to evaluate impressively sciency claims that are being made for treatments. And what is more sciency than neuroscience?

Psychotherapy is an inherently uncertain, subjective process. Isolated in sessions with clients, therapists do not have ready ways to monitor what is going on with confidence and decide moment to moment if it is helpful. Even when psychotherapy is manualized, done by the book, there is lots of uncertainty as to what is to be done when, to whom, whether it is done effectively, and how to follow-up.

Neuroscience seems to hold the promise of reducing some of that uncertainty. Exploitative hucksters make lots of money from therapists and their clients with claims that they can use neuroscience to monitor and direct the process of psychotherapy with precision. The hucksters play on the belief that changes in neural functioning can somehow serve to get more at what is “really” going on in therapy, beyond and, if necessary, in sharp contradiction of what therapists observe and clients report.

Enter workshop promoter Susan Johnson.  As told in the New York Times, she claims her emotionally-focused therapy (EFT)

can help couples break out of patterns, “interrupting and dismantling these destructive sequences and then actively constructing a more emotionally open and receptive way of interacting.” She aims to transform relationships “using the megawatt power of the wired-in longing for contact and care that defines our species,” and offers various exercises to restore trust.

Wow! If we could only monitor that interrupting and dismantling and the megawatt power of the “wired-in longing” with neuroscience.

In this blog post I discuss an article in PLOS One in which psychotherapist Johnson teams up with neuroscientist Jim Coan to claim they can do just that.

Ultimately, our handholding paradigm has provided a unique opportunity to test some of the proposed mechanisms of social support in general, and EFT in particular, all at the level of brain function, in vivo.

It is a terrible article, starting with its undisclosed conflicts of interests: Johnson is using the article to promote her psychotherapy products. And when we get past that, the article is shamelessly blatant cherry-picked evidence and poor psychotherapy research. We can learn from it as such.

Click in text for video

Click in text for video

But wait, hold on! Think of me like the greeter at the local Kanuka_BalmMacy’s department store who sprays you with free cologne or maybe rubs your hands with a soothing balm. Before we get into discussing the article, you can get a free sample of the Neurobalm right here that is being used to promote this psychotherapy product. See, no, feel for yourself. This is best appreciated wearing high-quality earphones to do the wonderful soundtrack justice.

Disclaimer: As you can already tell, I find this article outrageous and I am just getting warmed up in explaining how and why.  I am a PLOS One Academic Editor and I have gone on record insisting that promoters of psychotherapy be held to the same standards as the pharmaceutical companies in having to disclose apparent conflicts of interest. And now I have encountered an undisclosed conflict in the very journal where I work for free to provide a small bit of the oversight of the quality and integrity of what readers find there.

Oversight of conflicts of interest is far from perfect, especially when it depends on author disclosure. And oversight of the 24,000 articles published in PLOS One last year cannot be expected to be perfect.  But PLOS One has numerous tools to be self-correcting, especially when faced with undisclosed conflicts of interest. Unlike the journals Prevention Science and Clinical Psychology Review that I have been recently complaining about, PLOS One asks every author about potential conflicts of interest and every article published in PLOS One has an explicit declaration. And unlike these other two journals, PLOS One has explicit, orderly procedures for responding to apparent non-disclosures. An editor like myself, just like any reader, can make a complaint, and PLOS One will evaluate whether an inquiry to authors is necessary in order to decide what further action to take.

disclaimerThe opinions I am going to express here are my own, and not necessarily those of the journal or other members of the editorial board. Thankfully, at Mind the Brain, bloggers are free to speak out for themselves without censorship or even approval from the sponsoring journal. Remember what happened at Psychology Today and how I came to blog here.

The full text of the open access article is available here.

Abstract

Social relationships are tightly linked to health and well-being. Recent work suggests that social relationships can even serve vital emotion regulation functions by minimizing threat-related neural activity. But relationship distress remains a significant public health problem in North America and elsewhere. A promising approach to helping couples both resolve relationship distress and nurture effective interpersonal functioning is Emotionally Focused Therapy for couples (EFT), a manualized, empirically supported therapy that is strongly focused on repairing adult attachment bonds. We sought to examine a neural index of social emotion regulation as a potential mediator of the effects of EFT. Specifically, we examined the effectiveness of EFT for modifying the social regulation of neural threat responding using an fMRI-based handholding procedure. Results suggest that EFT altered the brain’s representation of threat cues in the presence of a romantic partner. EFT-related changes during stranger handholding were also observed, but stranger effects were dependent upon self-reported relationship quality. EFT also appeared to increase threat-related brain activity in regions associated with self-regulation during the nohandholding condition. These findings provide a critical window into the regulatory mechanisms of close relationships in general and EFT in particular.

Before co-authoring this PLOS One article with Susan Johnson, Jim Coan published a closely related 2006 study in Psychological Science. Coan received lots of press coverage, even before the article was available on the Internet. The blogger Neurocritic critiqued the press coverage and then followed up with a blog post critiquing the present PLOS One article.

Neurocritic provides some generally useful wisdom concerning interpreting statements about neural imaging, psychotherapy, and relationships. I think most neuroscientists would agree with him. If you are a therapist, you might want to bookmark his blog post for future reference when you feel slathered with Neurobalm from psychotherapy workshop gurus.

An extended excerpt from Neurocritic

Can neuroscience illuminate the nature of human relationships? Or does it primarily serve as a prop to sell self-help books? The neurorelationship cottage industry touts the importance of brain research for understanding romance and commitment. But any knowledge of the brain is completely unnecessary for issuing take-home messages like tips on maintaining a successful marriage.

In an analogous fashion, we can ask whether successful psychotherapy depends on having detailed knowledge of the mechanisms of “neuroplasticity” (a vague and clichéd term). Obviously not (or else everyone’s been doing it wrong). Of course the brain changes after 12 sessions of psychotherapy, just as it changes after watching 12 episodes of Dexter. The important question is whether knowing the pattern of neural changes (via fMRI) can inform how treatment is administered. Or whether pre-treatment neuroimaging can predict which therapy will be the most effective.

However, neuroimaging studies of psychotherapy that have absolutely no control conditions are of limited usefulness. We don’t know what sort of changes would have happened over an equivalent amount of time with no intervention. More importantly, we don’t know whether the specific therapy under consideration is better than another form of psychotherapy, or better than going bowling once a week.

Problems start  with the article’s title

Soothing the threatened brain: Leveraging contact comfort with Emotionally Focused Therapy.

This title titillates the unwary but triggers an alert among even open minded skeptics.

Some of you may recall that in the tips I gave for writing titles in the Colon Theory of Titles. I suggested that if you reserve one side of the colon in a title for keywords, you might use the other side to have a little fun attracting interest in your article.

Coyne, J. C., & van Sonderen, E. (2012). The Hospital Anxiety and Depression Scale (HADS) is dead, but like Elvis, there will still be citings. Journal of Psychosomatic Research, 73(1), 77-78.

Or the more outrageous

Krauth, S. J., Coulibaly, J. T., Knopp, S., Traoré, M., N’Goran, E. K., & Utzinger, J. (2012). An in-depth analysis of a piece of shit: distribution of Schistosoma mansoni and hookworm eggs in human stool. PLOS Neglected Tropical Diseases, 6(12), e1969.

Fair fun. But the problem with Soothing the Threatened Brain is that many of the therapists think there is something more profound about ‘soothing the brain’, rather than soothing the wife or her heart or her emotions. And this target audience is all too ready to believe that there is something special about promoters of emotion focused therapy claiming it soothes the threatened brain. EFT is better than other marital therapies because it works on the wife’s brain, not just a couple. Other therapies only do relationships or wives but EFT does brains.

If you think I am being too tough on therapists, you can do an informal experiment. Strike up conversations with a few therapists about how they understand the abstract and title of this article or the dramatic video is based on the study. I tried this, and though some expressed some skepticism, they really did not feel competent to argue with a peer-reviewed article or a video of a fMRI assessment.

undeclaredAppearance of conflict of interest

Competing interests: The authors have declared that no competing interests exist.

Funding. This research was supported in part by the International Centre for Excellence in Emotionally Focused Therapy (ICEEFT), a not-for-profit corporation whose mission includes the scientific evaluation of EFT. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Additional funding was provided by a National Institute of Mental Health grant, Award Number R01MH080725, awarded to JAC. No additional external funding received for this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

This does not ring true. The website of the International Center for Excellence and Emotion Focused Therapy lists Susan Johnson as founder and director. Not only did Susan Johnson design the study and interpret the data, she provided supervision of the therapy and somehow decided the particular time point at which women who had received the intervention would get fMRI assessment. As psychotherapy research, this is bizarre and breaks down any benefits of experimental control — the investigator with strong allegiance to her treatment gets to pick when outcome assessments are done rather than having preset times of assessment.

The website for Johnson’s for-profit Ottawa Couples and Family Institute indicates that it shares the same physical space and administrative staff as ICEEFT. The nonprofit corporation serves a number of marketing functions, including maintaining a referral list of therapists who have completed sufficient trainings to obtain the certification, as well as granting permission to otherwise unqualified persons to participate in workshops and get certification so they can practice in the community, often without licensure. Depending on the country or state, people who attend trainings can offer EFT for a fee without having a license or any regulation as long as they do not adopt a title that is regulated and licensed in that particular jurisdiction. This can be a matter of calling themselves a coach or counselor, depending on the jurisdiction.

This is a rather standard arrangement in the therapy training business, whereby profit-making activities are from ostensibly nonprofit certification that extends the market for trainings.

If readers were informed of financial interests at stake….

If a candid conflict of interest statement had been provided, readers would have been more prepared to independently and skeptically evaluate claims starting in introduction and colorful and on scientific language throughout.

For instance, the authors declare in the introduction

Early research suggested that EFT was superior to behavioral marital therapy [20], and a more recent meta-analysis [21] concluded that 70–73% of couples who undergo EFT are no longer relationally distressed at the end of therapy – at an average effect size of d= 1.3.

The evidence of superiority [20] refers to a 1986 study with 15 couples each assigned to EFT or behavioral marital therapy. It was a small underpowered study that can be discounted by its high risk of bias, including the developers testing their own therapy.

Let us get real. Accumulated psychotherapy studies suggest that it is quite unrealistic to expect that a comparison of 15 couples receiving a particular therapy versus 15 couples who were on a waiting list will yield a significant finding. There are also lots of studies suggesting only modest differences between credible, active, structured therapies like EFT versus behavioral marital therapy. It is highly unlikely that such findings would be obtained by honest and transparent reporting of well-done psychotherapy research by anyone without a dog in the fight.

The “more recent meta-analysis [21]” refers to a 1999 poor quality review and meta-analysis also conducted by developers of EFT.

The meta-analysis is worth a look. You can click on the table to the right and see the 7 table EFT meta-analysis 1999-1studies included. All were done by developers of EFT or as a dissertation under the supervision. Three studies are nonrandomized trials, one with only seven couples. All of the randomized trials have 16 or fewer couples assigned to EFT,  and so have less than 50% probability of detecting a positive result if it is present. All of the articles identified as positive studies.

Essentially this is a poor quality meta-analysis of what should have been left as pilot studies conducted by promoters of a therapy in their own lab. The meta-analysis lacks many of the formal features of meta-analyses including forest plots and assessments of risk of bias. The overall effect size of 1.31 is improbably high in the failsafe N of 49 studies being unpublished to unseat a positive evaluation EFT highlights the absurdity of invoking that statistic. If we took failsafe N seriously, we would have to accept that there would have to be almost as many unpublished null trials as there are couples in the published studies.

It is instructive to compare the assessment of the EFT from its developers to a more detached consideration about the same time by a group organized by American Psychological Association to evaluate the evidence-supported status of psychotherapies.

The APA group tell you things that somehow get missed in this review of EFT in PLOS One.

It is important to note that the interventions were restricted to moderately distressed couples because the investigators were concerned that EFT might not be optimal for extremely distressed couples.

Promoters of a psychotherapy rarely lose a comparison between the intervention they are rooting for and a rival comparison-control, particularly in a grossly underpowered study. However, that is exactly what occurred in one of the studies included in the meta-analysis were EFT was bested by strategic therapy in follow-up. This led the APA group to declare systemic therapy “possibly efficacious.” I doubt this kind of upset has ever happened in formal evaluations of psychotherapy research. Of course, the APA group’s rules are kind of loopy and I would not give this evaluation too much credence. Nonetheless, the APA group goes on:

This difference between treatments resulted from the couples in the EFT treatment experiencing significant relapse during the follow-up period. The investigators noted that couples in this study were much more distressed than couples in the Johnson and Greenberg study, which might account for the differences seen in the two studies at follow-up. They cautioned that, with severely distressed couples, time-limited EFT might not be powerful enough to create sufficient intimacy to maintain posttest gains.

Compare this to what Susan Johnson says in the PLOS article:

 Moreover, EFT treatment gains realized among distressed couples at high risk for relapse are stable over two- and three- year assessment periods [22,23]. *

Art Garfunkel’s Mr Shuck ‘N Jive http://tinyurl.com/k7wbwo4

Art Garfunkel’s Mr Shuck ‘N Jive http://tinyurl.com/k7wbwo4

The discrepancy can be explained by picking and choosing particular timepoints for particular tiny psychotherapy follow-up studies with highly selected, on representative patients.  Come on Susan, you’re shucking us. This has little resemblance to finding best evidence, you are just finding evidence to sell your psychotherapy.

The APA group also noted some differences in the outcomes of a waitlist control group in behavioral marital therapy conducted by its originator, Neil Jacobson:

Whereas 50% of James’s [an EFT study done by a dissertation student] waiting list couples improved without treatment, the waiting list couples in the BMT studies reviewed by Jacobson et al. showed an improvement rate of only 13.5%.

So, even the waitlist control groups do better in the EFT versus BMT studies.

Johnson continues her overview of the literature in the PLOS One introduction.

EFT has also been successfully applied to couples in which one or both partners are coping with a history of childhood sexual abuse [28,29], major depression [30,31], and even breast cancer [32].

You are shucking us again, Susan. What constitutes being “successfully applied”? These are not randomized controlled studies. For instance, the application to breast cancer involved only to patients. You are hardly in a position to crow about this. Shame on you.

When I read an introduction to a scientific article, I expect a much more nuanced, balanced consideration of the existing literature in a way that leads up to the research question of a particular study. What we get in this introduction in no way resembles us. Rather, an author with undeclared conflicts of interest is shamelessly hawking her psychotherapy product.

But stay tuned. In Part Two of this blog post I will offer a detailed critique of the methodology and interpretation of the actual study. It would be great if readers read the open access PLOS One article ahead of my next post and were prepared with their own interpretations and maybe even to dispute mind.

*The EFT literature and apparently what is said in workshops provide strong claims about outcomes that are echoed in the advertisements of therapists who get certified in EFT. For instance, the website of a Philadelphia-based therapist claims

EFT ad

Click to enlarge

This is either an exaggeration or outright fraud if it is supposed to represent the likelihood of a positive outcome of a couple coming to this therapy.

conflict of interest

 

Category: Conflict of interest, evidence-supported, mental health care, neuroscience, psychotherapy | Tagged , , , | 4 Comments

Repost: The Latest and Greatest in Treatment for PTSD: Magic Bullets and Cutting Edge Innovation

June is PTSD awareness month.  In light of this, I am reposting a blog I wrote about “The Latest and Greatest in Treatment for PTSD.”  If you are interested in knowing more about PTSD please check out the NCPTSD website.

Also, below are links to other blog posts I have written about PTSD and related topics:

 

The Latest and Greatest in Treatment for PTSD: Magic Bullets and Cutting Edge Innovation

I am frequently asked to talk about PTSD to professional audiences and, without 2012-04-05-ptsd1exception, always get a post talk question asking about my experience with some experimental intervention that someone read about somewhere in a newsmagazine or heard about from the T.V.

Internally, I always groan.

Having just spent 60-90 minutes pouring over carefully crafted PowerPoint slides that contain information about the evidence base for the treatments of PTSD and what best practices consist of, why I am always confronted with a zealous audience member who is obsessed with the new, the innovative, or the magic bullet?

In the interest of full disclosure, I have to share my viewpoint as being that of a health services researcher.  I approach PTSD treatment with a basic belief that we already have pretty good treatments, and the issues with getting better outcomes for PTSD lie more in how we implement those treatments, the limitations of the systems that provide care, massive issues of access to care (i.e. those who need care the most simply can’t access it for a myriad of reasons), and healthcare disparities (that an individual’s outcomes for PTSD are more likely linked to their zip code as opposed to their genes/neurotransmitters).

In short, I usually have a healthy skepticism toward the experimental or magic bullets type of treatments for PTSD, which often get a lot of media attention and can be very seductive to the brain of a researcher or clinician who spends their days trying to help individuals who live with PTSD.

 

Still, today I am curbing my skepticism and with much enthusiasm am writing about some of the hottest ideas for innovation in the treatment of PTSD.

 

Please note: MANY of these approaches are still considered EXPERIMENTAL, and I am listing them in no particular order of importance.

1. Mind – Body Practices for PTSD

Image Credit: Cornelius383

Mind Body practices are increasingly used to offer symptom reduction for PTSD.  Approaches such as Yoga, Tai Chi, Mindfulness Based Stress Reduction, Meditation, and Deep breathing are some examples.  There are about 16 rigorous studies that have been done to date, most of which have small sample sizes.  Whilst early findings suggest such practices can have a beneficial impact on symptoms like intrusive memories, avoidance, and increased emotional arousal, there is insufficient evidence to support their use as standalone treatments, though they can be recommended as an adjunctive treatment.

 

2. Cervical Sympathetic Blockade and Stellate Ganglion Block for PTSD 

In 2008, reports started to emerge about a minimally invasive manipulation of sympathetic nerve tissue in patients with PTSD that relieved their anxiety.  The procedure consisted of injecting a local anesthetic into sympathetic cervical nerve tissue at the C6 level and was apparently accompanied by immediate relief by the patient.  In 2012, a case series was reported where treatment resistant veterans with PTSD were given a stellate ganglion block and also a pre and post intervention CAPS. After the intervention, 5/9 of the patients experienced significant improvement; these benefits diminished over time and the benefits were not universal.  Controlled trials are currently underway to investigate this intervention further.

 

3. Virtual Reality Exposure Therapy

Virtual Reality exposure therapy utilizes real time computer graphics, body tracking devices, visual displays, and other sensory input devices to give the patient the experience that they are immersed in a virtual environment. It is an enhanced version of the imaginal exposure typically utilized as a part of trauma-focused psychotherapies. In 2001 an open clinical trial of Virtual Reality exposure therapy yielded promising results. It is currently being studied under controlled conditions.

 

4. D-Cycloserinemanypills

D-Cycloserine is a partial agonist of the NMDA receptor (a brain receptor that plays an essential role in learning and memory). It has been used to treat social phobia and panic disorder and to enhance the effects of psychological therapies for those disorders.  Preliminary data suggests it can be a useful adjunct in addition to evidence-based psychotherapies for patients living with severe PTSD.

 

5. Ketamine

Ketamine is a non-barbiturate anesthetic and antagonist at the NMDA receptor that is typically administered intravenously.  It has been used for years for patients with severe burns and it was, in this use, that its dissociative properties became apparent.  Retrospective studies show that those who received Ketamine after a traumatic event were less likely to develop PTSD.  It has been postulated that Ketamine may disrupt the process via which traumatic memories are laid down. A 2014 JAMA study reported on a RCT which demonstrated a rapid reduction in symptom severity following Ketamine infusion in patients with chronic PTSD.

 

6. Increasing the Intensity of Treatments

In an experimentation with packaging, British researchers compressed versions of trauma-focused psychotherapies for PTSD into a seven day intensive treatment.  This was found to work as well as treatment as usual, which is the same treatment delivered once a week, over 12 weeks.  Such an approach was postulated to be more efficient and convenient and was associated with faster improvement in symptoms and lower dropout rates.

 

7. Memantine colorful-pills

Memantine is a non competitive NMDA antagonist that is thought to protect the glutamergic destruction of neurons and hence prevent the hypothesized neurodegeneration in the hypothalamus, which contributes to the memory issues related to PTSD.  In a 2007 open label small trial, Memantine was found to be associated with some encouraging outcomes.  Double blind placebo controlled trials are pending.

Category: alternative medicine, Commentary, mental health care, Psychiatry, PTSD, research | Tagged , , , , | 1 Comment