Lucrative pseudoscience at the International Positive Psychology Association meeting

By James Coyne PhD
Posted: July 15, 2015

A plenary session dripping with crank science may be an outlier, but it’s on a continuum with the claims of mainstream positive psychology.

 Follow the conference attendees following the money, does it take you to science?

Imagine…

HMI-Bio-Speaker-Rollin-217x300Imagine a PhD student going to her first positive psychology conference, drawn by the opportunity to hear research oriented psychologists such as Richard Davidson and Jonathan Haidt in one place. But at the first plenary session she attends, Rollin McCraty is talking to an enthralled audience about “the science of what connects us.” McCraty says the heart radiates a measurable magnetic field which carries emotional state information, and can be detected by the nervous systems of nearby.”

Puzzled, she googles McCraty and comes to websites and articles making even more bizarre claims, like

 There is compelling evidence to suggest that the heart’s energy field (energetic heart) is coupled to a field of information that is not bound by the classical limits of time and space.

And even better

This evidence comes from a rigorous experimental study conducted to investigate the proposition that the body receives and processes information about a future event before the event actually happens (McCraty et al 2004a, b). The study’s results provide surprising data showing that both the heart and brain receive and respond to pre-stimulus information about a future event. Even more tantalizing are indications that the heart receives intuitive information before the brain, and that the heart sends a different pattern of afferent signals to the brain which modulates the frontal cortex.

“…about a future event before the event actually happens”? Wow, this puts Daryl Bem’s  claim of precognition to shame. But this claim cannot possibly prepare our PhD student for

A Tidal Wave of Kindness

In the fall of 2013, the IHM [Institute of HeartMath, where McCraty is Director of Research] launched the Global Coherence Initiative. The ambitious goals of this campaign are unprecedented: to quantify the impact of human emotion on the earth’s electromagnetic field and tip the global equation toward greater peace. While this may sound like a utopian fantasy, Dr. McCraty points out that science once again supports this possibility. “If the earth’s fields are a carrier, we are all coupled to this field, all the signals are out there,” he says. “So every emotion we experience is coupled to that field. This creates a global humanity field, if you will.” According to Dr. McCraty, this field is continually fed by our feelings, both positive and negative. The goal is to shift the balance toward the positive. “Any time we’re putting out love and kindness, that energy is not wasted,” he adds.

HeartMath graphThis is crank science far beyond the satire of Alan Sokal hoax article, Transgressing the Boundaries: Towards a Transformative Hermeneutics of Quantum Gravity. But we’re not done yet:

Current IHM research demonstrating the interconnectedness between people has Dr. McCraty very excited. Two studies going on in northern California and Saudi Arabia are monitoring HRV 24/7 to help quantify the interconnectivity between people and how it is affected by nervous system dynamics, the earth’s magnetic fields, solar flares, and even radio frequencies.

happy facesAt the reception that evening, our PhD student desperately searches for familiar faces of other research oriented PhD students. She manages to find only a few among the oppressively bubbly crowd. And none of her colleagues actually went to the McCraty plenary. Some dismissed him as just pushing the merchandise of the very commercial HeartMath.

Who was attending the International Positive Psychology Association meeting?

Advertisements for the conference advised

who should attend

But any research-oriented attendees were disappointed if they sought first-ever reports of breakthrough, but reproducible science. Personal coaching and organizational and executive consulting themes predominated in the preconference workshops and presentations.

Elements of a trade show blended into a revivalist meeting. Hordes of “certified” life coaches and wannabes were seeking new contacts, positive psychology products, and dubious certificates to hang in their offices. These coaches had paid out-of-pocket, without scholarship for degrees from “approved” masters of arts in positive psychology programs (MAPPs) costing as much as $60,000 a year. Many were hungry. But there are inspiring -positive psychology is about inspiring- stories on the Internet of big bucks being made immediately:

make money

  • MAPP programs typically require no background in behavior science and provide very little training in critical appraisal of research or even ethics.
  • Graduates of MAPP programs general lack ability to determine independently whether claims are evidence-based. They are suckers for anything that superficially sounds and looks sciencey. They are as vulnerable as marital and family therapists who can be readily seduced by claims about therapies that are “soothing the brain” hawked by unscrupulous “neuroscientists” and self-promoters.

Indeed, just go to some coaching websites and see claims of being able to provide clients with wondrous transformations take takes little effort from them.

Positive psychology merchandise. Get certified as a trainer now.

The science is often superficial and even quack. Yet, to compete effectively in a crowded field, positive psychology coaches brandish a label of ‘we are more sciencey than the rest’.the pp scientist

McCraty’s HeartMath promises that big time science backs its claims of effectiveness.

Over the years we have received numerous reports that coherence training has improved performance in a wide range of cognitive capacities, both short and long-term. These include tasks requiring eye-hand coordination, speed and accuracy, and coordination in various sports as well as cognitive tasks involving executive functions associated with the frontal cortex such as maintaining focus and concentration, problem solving, self-regulation, and abstract thinking.

A study of California correctional officers with high workplace stress found reductions in total cholesterol, glucose, and both systolic and diastolic blood pressure (BP), as well as significant reductions in overall stress, anger, fatigue and hostility with projected savings in annual heath care costs of $1179 per employee (McCraty et al 2009).

stand back scienceUnfortunately McCraty et al 2009 turns out to be a rather dodgy source

McCraty R, Atkinson, M., Tomasino, D., & Bradley, R. T (2009) The coherent heart: Heart-brain interactions, psychophysiological coherence, and the emergence of system-wide order. Integral Review 5: 10–115.

But why stop there?

Hospitals implementing HM programs implementing have seen increased personal, team and organizational coherence. The measures most often assessed are staff retention and employee satisfaction. Cape Fear Valley hospital system in Cape Fear, North Carolina, reduced nurse turn over from 24% to 13%, and Delnor Community Hospital in Chicago saw a similar reduction from 27% to 14% – as well as a dramatic improvement in employee satisfaction, results that have been sustained over an eight year period. Similarly, Duke University’s Health System reduced turnover from 38% to 5% in its emergency services division. An analysis of the combined psychometric data from 3,129 matched pre-post HM coherence trainings found that fatigue, anxiety, depression and anger were reduced by almost half. Another workplace study conducted in large chain of retail stores with in-store pharmacies that employed 220 pharmacists across multiple locations found a reduction is medical errors ranging from 40 to 71%, depending on the store location (HeartMath 2009).

Specific statistics, yes, but, alas, these data are not independently peer reviewed claims nor even transparently presented. They call upon our faith in HeartMath.

If your methods are so powerful, HeartMath, submit your evidence for legitimate peer review.

Shame on me for not doing a systematic review of this literature.

When I posted a critical comment about McCraty on my Facebook wall, I was quickly chastised by a “friend” whom I do not actually know:

Have you read the body of research published by HeartMath? Which articles have you critically reviewed and found flawed? Can you discuss that in detail? Do you know what the Global Coherence Project is? Do you know those methods, their datasets? Are you dismissing this on the idea alone, or on the details of their generated body of scientific work? Are you an expert on electrical fields generated by the human body? Do you know all the work on heart rate variability and its associations with human health and communication? Which part of that body of work are you taking issue with?

Dear Facebook “friend,” don’t you realize that the burden of proof lies on the quacks who wish us to believe ridiculous claims with zero obvious scientific basis? Evidence, please. No plausible mechanism means not worth a serious investigation. And by the way, does anyone know ‘their methods, their data sets,’ outside of HeartMath?

There is so much junk out there and so little time to evaluate it. Skeptics should not waste their time, when they quick-screen for plausible mechanism and find none. That eliminates the bulk of the nonsense bombarding us, even from successful academic positive psychology gurus. Sure, we might miss some dramatic breakthroughs, but prior probabilities are on our side.

The positive psychology – corporate – military complex

Touchy question in the positive psychology community: Was US Defense Department grant money used to reward psychologists for involvement in the CIA torture program for those who protected them from ethical sanctions? There has not been much discussion of this on the tightly controlled Friends of Positive Psychology listserv, only swift denials, but can others get in on the money? Can Rollin McCraty help? A good reason to go to his talk. But, first, some background.

Psychologist Stephen Soldz, Ph.D and colleagues produced a report, American Psychological Association’s Secret Complicity with the White House and US Intelligence Community in Support of the CIA’s ”Enhanced” Interrogation Program. The report contained a number of linked emails that included Paul Ekman, James Mitchell and…Marty Seligman.

Blogger Vaughan Bell states

 To be clear, I am not suggesting that Ekman and Seligman were directly involved in CIA interrogations or torture. Seligman has gone as far as directly denying it on record.

But there is something else interesting which links Ekman, Seligman and Mitchell: lucrative multi-million dollar US Government contracts for security programmes based on little evidence.

Seligman was reportedly awarded a $31 million US Army no-bid contract to develop ‘resilience training’ for soldiers to prevent mental health problems. This was surprising to many as he had no particular experience in developing clinical interventions. It was deployed as the $237 million Comprehensive Soldier Fitness programme, the results of which have only been reported in some oddly incompetent technical reports and are markedly under-whelming. Nicholas Brown’s analysis of the first three evaluative technical reports is particularly good where he notes the tiny effects sizes and shoddy design. A fourth report has since been published (pdf) which also notes “small effect sizes” and doesn’t control for things like combat exposure.

Money from the ineffective Comprehensive Soldier Fitness Progam has been an enormous bonanza for positive psychologists – and even critics willing to mute what they say. Is Rollin McCraty a useful way in? Aside from being Director of Research at Institute of HeartMath (IHM), Rollin McCarty is also Director of Military Training – the HeartMath website tells us – he is working with Major Robert A. Bradley (USAF, Ret., Director of Veterans Outreach.

HeartMath once had a million dollar grant from the US Navy. Their grant portfolio has apparently shrunk to a few thousand dollars. But HeartMath offers training and certification in nice sounding programs. Can hungry MAPP graduate attendees get trained and certificates suitable for framing and make big bucks through HeartMath? The hell with the science, there are sciencey claims that must sell.

We cannot tell how much profit HeartMath is making. We can only get the financial details on their not-for-profit institute, not their for-profit wing. The split between profit and nonprofit wings of training institutes making money and the secrecy is common in training enterprises a common organizational structure for entrepreneurs.

An outlier, but on a continuum with positive psychology (pseudo) science?

Rollin McCraty may be an outlier, but he still lies on a continuum with the most recognized scientists of positive psychology.

Barbara Fredrickson is considered a rock star in the positive psychology community. She has an endowed chair, lots of grant money, and numerous publications in journals where you would never find Mcraty. Yet her papers are often tied to her heavily marketed commercial products, though without the requisite declaration of conflict interest in her papers. Some of her claims have not fared so well with strong hints of shaky and even pseudo science.

Positivity ratio. Fredrickson and Losada (2005) infamously applied a mathematical model drawn from nonlinear dynamics and claimed that a ratio of positive to negative affect of exactly 2.9013 separated flourishing people from those who are merely languishing. Nick Brown, Alan Sokal, and Harris Friedman examined this claim and found

no theoretical or empirical justification for the use of differential equations drawn from fluid dynamics, a subfield of physics, to describe changes in human emotions over time; furthermore, we demonstrate that the purported application of these equations contains numerous fundamental conceptual and mathematical errors.

In response, Fredrickson partially retracted her claim, where visitors can take a 2- minute test to determine whether they are flourishing or languishing and watch Youtube videos.

Meaning is healthier than happiness. Fredrickson and colleagues claimed to have used functional genomics to settle the classical philosophical question of whether we pursue meaning (eudaimonism) in our lives or happiness (hedonism). These claims echoed in the popular press  as

People who are happy but have little-to-no sense of meaning in their lives have the same gene expression patterns as people who are enduring chronic adversity.

My colleagues and I (including Nick Brown and Harris Freidman) took a critical look and reanalyzed Fredrickson and colleagues’ data. We concluded

Fredrickson et al.’s article conceptually deficient, but more crucially that their statistical analyses are fatally flawed, to the point that their claimed results are in fact essentially meaningless.

The journal where the article originally appeared, PNAS has so far resisted a number calls, including one from Neuroskeptic for retraction of the original article.

Better health and relationships through loving kindness meditation. Much like McCarty, some of Fredrickson’s work makes strong claims about transforming people’s lives by changing cardiac vagal tone. She and colleagues claimed to have shown that practicing loving-kindness meditation (LKM) generates an “upward spiral” of mutual enhancement among positive emotions, social connectedness, and physical health. So,

“Advice about how people might improve their physical health . . . can now be expanded to include self-generating positive emotions.”

My group -again with Nick and Harris, but also James Heathers – took a closer look and reanalyzed the data. We found the study was actually a badly reported clinical trial with null results, evidence concerning the association of cardiac vagal tone and established valid parameters of physical health were contradictory, and carrdiac vagal tone was certainly not a suitable proxy outcome for health in a clinical trial, especially for persons of the age included in Fredrickson’s trial.

love 2Nonetheless, the first hit when I googled “Fredrickson loving kindness meditation” was another Fredrickson commercial website, Love 2.0  offering a book and other products with an eye-catching question:

What if everything you know about love is wrong?

It’s time to upgrade your view of love. Love 2.0 offers new lenses for seeing and more fully appreciating micro-moments of connection. Dr. Barbara Fredrickson gives you the lab-tested tools to unlock more love in your life.

Any wonder why the attendees at International Positive Psychology Association had trouble distinguishing between science and nonsense like what McCarty offered?

 

 

Category: coaching, genomics, happiness, hedonia, positive psychology, social genomics | Tagged , , , , , , , | 7 Comments

Advocating CBT for Psychosis: “Ultimately it is all political.”

By James Coyne PhD
Posted: June 30, 2015

Political… Or just cynical?

Frida Kahlo, “Without Hope”

Frida Kahlo, “Without Hope”

Professor Paul Salkovskis and his colleagues organized a lively, thought-provoking conference at University of Bath “Understanding Psychosis and Schizophrenia: How well do we understand and what should we do to improve how we help?”

Presenters and members of the roundtable discussion panel included a number of authors of the British Psychological Society’s Understanding Psychosis and Schizophrenia. But they noticeably  avoided engaging anyone outside their tight knit group, especially speakers disagreeing with their manifesto. The Understanding Psychosis and Schizophrenia authors appeared glum and dyspeptic throughout lively discussions. The conference nonetheless went on around them. Highlights included presentations by Professors Robin Murray and Clive Adams.

In his “Genes, Social Adversity and Cannabis: how do they interact?” Professor Robin Murray gently chided the authors of the British Psychological Society’s Understanding Psychosis and Schizophrenia for their insensitivity to the suffering, debilitation, and sometimes terror posed by schizophrenia. For me, his talk clarified confusion caused by the authors of Understanding Psychosis repeatedly claiming Professor Robin Murray had endorsed their document. He did not. He is an exceptionally kind and well-mannered person and I think his polite comments at the earlier launch meeting for Understanding Psychosis were misinterpreted. His presentation at the Bath conference left no doubt where he stood.

A diagnosis of schizophrenia encompasses a wide range of conditions that will undoubtedly by sorted into a tighter, more useful categories as we use existing categories to organize the evidence we accumulate. As Joe McCleary summarized in comments on my FB wall, if we use existing – admittedly imperfect and provisional – categories, we can learn about

the nature of the individuals symptoms and experience, the likelihood and time course of improvement, recovery, and/or relapse, persistence of difficulties in particular domains (intellectual, social, emotional, adaptive functioning), which interventions might be most useful to try, what co-occurring disorders and risks are high and low (e.g., suicide, aggression, dissociation), likely levels of dependence vs independence, impacts on family, reliance on family, impacts on society, reliance on society, risk for harm (e.g., being taken advantage of or abused), etc., etc., etc.

These correlates of a diagnosis of schizophrenia check out well when we go to the available literature.

Professor Peter Kinderman who is President-Elect of the British Psychological Society, as well as an author of Understanding Psychosis was a member of the afternoon roundtable panel at Bath But he mostly sat in silence. He rejects the idea that the diagnosis has led to any progress:

Diagnostic systems in psychiatry have always been criticized for their poor reliability, validity, utility, epistemology and humanity.

And

The poor validity of psychiatric diagnoses—their inability to map onto any entity discernable in the real world—is demonstrated by their failure to predict course or indicate which treatment options are beneficial, and by the fact that they do not map neatly onto biological findings, which are often nonspecific and cross diagnostic boundaries.

Kinderman repeats these points in every forum he’s given until he lapses into self-plagiarism. Compare Imagine there’s no diagnosis, it’s easy if you try  to Drop the language of disorder.

What does Kinderman offer in place of diagnosis? That we respond to patients in terms ofmy paradigm their nonspecific distress, which is a “normal, not abnormal, part of human life.” This insight, according to Kinderman, places us on the “cusp of a major paradigm shift in our thinking about psychiatric disorders.”

Kinderman leaves us with sweeping declarations and no evidence to support them. He gets quite fussy when challenged. During the Roundtable Discussion, he went off on one of his usual rants, peppered by a torrent of clichés, allusions to unnamed professionals describing schizophrenia as a genetic disease, and argument by anecdote.

But what if we took seriously his suggestion that we drop diagnosis and substitute a generic distress? He concedes that many patients are helped by antipsychotic medication. But getting the best candidates for this treatment depends on the diagnostic label schizophrenia. And just as importantly, keeping patients who are likely to be poor candidates and for whom it will be ineffective, also depends on using the criteria associated with the label schizophrenia to rule out this treatment is appropriate. Unless Kinderman can come up with something else, it would seem that we risk both undermedication of those who desperately need it and overmedication of those who get more harm than benefit, if we abandon such labels.

And turning to Professor Clive Adam’s presentation organizing the available literature around the diagnostic label of schizophrenia, we can see from Cochrane reviews the likelihood that treatment with cognitive behavior therapy in the absence of medication is likely to be ineffective and not at all based on available evidence.

Clive Adams delivered a take-no-prisoners “CBT-P and medication in the treatment of psychosis: summarising best evidence.”  Adams’ presentation is captured in a blog post but its message can be succinctly stated

I just cannot see that this approach (CBTp), on average, is reaping enough benefits for people.

None of the authors of Understanding Psychosis responded to Adams’ strictly data oriented presentation. They simply mumbled among themselves.

Maybe we should simply accept that when the authors of Understanding Psychosis call for extensive discussion and dialogue, it is not what would be usually meant by those terms. They don’t want their monologue  interrupted by anything but  applause.

What the authors of Understanding Psychosis  get is that with Twitter and blogs, you cannot not engage in a dialogue when you put outrageous claims out there. You can only risk your social media identity being defined what others say.

Let’s examine what Peter Kinderman says in another monologic blog post, strikingly free of any reference to evidence, Three phrases. The post discusses three phrases that organized an international meeting concerning cognitive behavior therapy held in Philadelphia in May, 2015.

It’s probably better to read the outcomes of our discussions in peer-reviewed scientific papers and in the policy documents of our various nations. For me, however, three phrases stood out as we discussed our shared interests.

I can’t wait! But until then we have his blog.

The first phrase “Trauma-informed practice” is described

In all kinds of ways, we’re learning how psychotic experiences can relate to trauma – in childhood and as adults. And we’re learning how the ways in which we purport to care for people – with the labels that we attach to their problems, with the explanations (and non-explanations) that we propose, and especially with the treatments that we use (and occasionally impose, even forcefully) – can potentiate experiences of trauma. So I welcome the fact that there appears to be increasing discussion of how we might base our therapies, and indeed our whole service design philosophy, on an appreciation of the role of trauma, for many people, in the development of their difficulties.

Presumably the forthcoming “peer-reviewed scientific papers” will allow us to evaluate the evidence for the efficacy of “trauma-informed” treatment of schizophrenia. I can’t find it. I don’t see where any of the randomized trials of CBT for psychosis that have been conducted are organized around this concept. Does Kinderman have any sense of the history or usage of “trauma-informed” in the United States and elsewhere?

mindbody connection“Trauma informed practice” typically refers to an approach that is more hermeneutic than scientific. The assumption is made that psychological trauma causes both mental disorder and physical illnesses.

Understanding Psychosis takes for granted that traumatic experiences are at the root of most psychotic disturbance. When they invoke evidence at all, it is the work of one of its authors, Richard Bentall. The literature concerning the role of child adversity in psychotic disturbance is  methodologically flawed, but even if we accepted at face, the effect sizes it generates would not justify the assumptions that trauma is behind all psychotic experiences.

In the United States, evidence-based, research-oriented clinicians are skeptical of the slippery slope whereby calls for “trauma-informed practice” too often lead down to nonsense about trauma being embodied in organs and peripheral tissue, not just the nervous system. Untrained and incompetent therapists insist that conditions like diabetes and asthma are linked to trauma, and if patients cannot report relevant traumatic experiences, there should be an effort to recover their repressed memories. Serious damage was done to a lot of patients and their families before the fad of recovering memories of sexual abuse and participation in devil worshiping cults was put down with legal action.

Kinderman’s second phrase is “CBT-informed practice”

It’s hardly a surprise that the acronym ‘CBT’ means slightly different things to different people.

There’s a valuable debate about ‘fidelity’ (whether a therapist is or is not adherent to the accepted elements of CBT). But there’s also an appreciation that, in the field of psychosocial interventions in mental health care, common therapeutic factors, the fundamental role of a good ‘therapeutic alliance’ (a relationship based on respect) and the heterogeneity of individual experiences means that we are now much more likely to talk about “CBT-informed practice”. Again, for me, this is welcome. I believe that it not only allows for valuable innovation and development of psychosocial interventions, but also permits an appreciation of the uniqueness of each person’s experience.

The retreat from any claim to being evidence-based continues. If a therapy carries the branding of evidence-based, it is assumed that it is delivered with some fidelity to what has been tested in clinical trials. Branding as “evidence-based” cannot be retained unless the innovations and further development are themselves subjected to clinical trials. “Evidence-based, is not a branding they can be casually transferred to new products without testing.

Kinderman’s final phrase is “_ ultimately, it’s all political_.”

The attendees of these meetings are all applied scientists (although some have some influential roles in shaping healthcare policies). But it was interesting that many of our discussions referred back to the social circumstances of those people accessing our services, and on the political decisions taken about how those services are commissioned, planned and delivered We discussed, for instance, the role of social determinants of health generally and mental health in particular. We discussed how different psychological and social problems seem to have similar social determinants (and the implications of this). We talked about how trauma, discrimination, racism, the struggles of undocumented migrants and the pressures on unemployed people can affect their mental health. We discussed how people access high-quality healthcare in different states and nations, and we discussed how political decisions – such as those related to involuntary detention and compulsory treatment, the funding of healthcare and provision of different forms of care – impact on our clients. We also discussed how, as a group of professionals, we are increasingly being asked to contribute to these debates.

So for me, it was a very positive and encouraging trip. I am – I remain – confident that conventional CBT, a form of one-to-one therapy that of course has its limitations, can be very positive for people experiencing psychosis. But, given the views I hold about the fundamental nature of mental heath and wellbeing, the phrases that echo most encouragingly from last week’s meeting are “trauma-informed practice”, CBT-informed practice” and “ultimately, it’s all political.”

I think I finally get it. Kinderman is saying that his followers should hold on to claims of being evidence-based, even in the face of clinical trials and meta-analyses providing evidence to the contrary. And they should incorporate elements of “trauma-based practice.” This is not taking  seriously principles of evidence-based evaluation of best practices. but that is not what Understanding Psychosis is about.

Advocating CBT is political, not evidence-based, but we need the latter label for credibility and controlling credentialing.

This is cynical, not political.

Category: antipsychotics, cognitive behavioral therapy, distress, evidence-supported, professional organizations, psychotherapy, schizophrenia | Tagged , , | 2 Comments

Consistently poor coverage of mental health issues in The Guardian

By James Coyne PhD
Posted: June 27, 2015

Issuing a readers’ advisory: The Guardian provides misleading, badly skewed coverage of mental health issues vitally important to mental health service users.

Guardian PulitzerStories in The Guardian can confuse and disempower mental health service users seeking information for difficult decisions about choosing and sticking to treatments. Articles labeled Psychology and Health and sometimes Science don’t adhere to the quality that earned The Guardian a Pulitzer Prize.

In this issue of Mind the Brain, I show why there should be a formal readers advisory for mental health information appearing in The Guardian. The excellent watchdog of faulty health coverage in the media, NIH Choices: Behind the Headlines  should routinely monitor stories appearing in The Guardian and provide more balanced analyses.

NHS choices

 

 

 

 

You can compare my assessments to your own evaluation with the links I provide to the stories in The Guardian.

Some recent examples:

At last, a promising alternative to antipsychotics for schizophrenia

Imagine that, after feeling unwell for a while, you visit your GP. “Ah,” says the doctor decisively, “what you need is medication X. It’s often pretty effective, though there can be side-effects. You may gain weight. Or feel drowsy. And you may develop tremors reminiscent of Parkinson’s disease.” Warily, you glance at the prescription on the doctor’s desk, but she hasn’t finished. “Some patients find that sex becomes a problem. Diabetes and heart problems are a risk. And in the long term the drug may actually shrink your brain.”

It is insulting to those who suffer from schizophrenia to have their life-altering experience trivialized and domesticated as simply “feeling unwell for a while.”

The article provides a fright-mongering depiction of the difficult choice that patients with schizophrenia face. Let’s give a critical look at the authors’ claim about drugs shrinking the brain. The sole citation is a PLOS One article. Authors of that article provided a carefully worded press release:

A study published today has confirmed a link between antipsychotic medication and a slight, but measureable, decrease in brain volume in patients with schizophrenia. For the first time, researchers have been able to examine whether this decrease is harmful for patients’ cognitive function and symptoms, and noted that over a nine year follow-up, this decrease did not appear to have any effect.

The UK senior author of the study further clarified:

doesn't appear

 

 

 

 

The study is not a randomized trial in which the amount of antipsychotic medication that patients received was manipulated. It is a small observational study comparing 33 patients with schizophrenia to 71 controls. Causal interpretation depends on statistical manipulation of correlational data. Yet a group of only 33 (!) patients with schizophrenia does not allow reliable multivariate analysis to explore alternative interpretations of the data. One plausible interpretation is that the amount of medication particular patients received is tied to severity of course of their schizophrenia. This would be a classic example of confounding by indication. The authors acknowledge this possibility:

It is conceivable that patients with the most severe illness lose more brain volume over time, reflecting intrinsic aspects of the pathology of schizophrenia, and the fact that severely ill patients receive higher doses of medication.

They further note:

Whilst it is extremely important to determine the causes of loss of brain volume in schizophrenia, an equally important question concerns its clinical significance. Loss of brain volume occurs throughout the majority of adult life in the healthy population, and whilst it might seem trivial that this would be disadvantageous, in some periods of development loss of brain tissue appears to be potentially beneficial [43]*.

Yes, antipsychotic medication poses serious side effects, doesn’t cure schizophrenia, and there are problems with adherence. But The Guardian article fails to note that the longer an episode of schizophrenia goes untreated, the less likelihood that a patient will ever resume a semblance of a normal life. And schizophrenia is associated with a 10% rate of suicide. What alternative does The Guardian article suggest?

A team led by Professor Anthony Morrison at the University of Manchester randomly assigned a group of patients, all of whom had opted not to take antipsychotics, to treatment as usual (involving a range of non-pharmaceutical care) or to treatment as usual plus a course of cognitive therapy (CT). Drop-out rates for the cognitive therapy were low, while its efficacy in reducing the symptoms of psychosis was comparable to what medication can achieve.

You can compare this summary to my critiques [1,2].

  • “Drop out rates..,were low?” The study retained fewer participants receiving cognitive therapy at the end of the study than there were authors.
  • The comparison treatment was ill-defined, but for some patients meant no treatment because they were kicked out of routine care for refusing medication.
  • A substantial proportion of patients assigned to cognitive therapy began taking antipsychotic medication by the end of the study.
  • There was no evidence that the response to cognitive therapy was comparable to that achieved with antipsychotic medication alone in clinical trials.

The authors of the study backed down from this last claim in an exchange of letters [1 and 2] at the Lancet with myself and others. BBC News dropped that claim after initially making it in coverage of the study.

as effective

 

 

Became

moderately effective

 

 

Don’t settle for my interpretation of the literature concerning cognitive therapy for psychosis (CBTp), go to a summary of available evidence in a blog post by Clive Adams, Chair of Mental Health Services Research and Co-Ordinating Editor of the Cochrane Schizophrenia Group at the University of Nottingham.

Adams wraps up with

Where does this leave CBTp?

In the opinion of this writer, having read and thought about the reviews (and others in some detail) it is time to move on.

It is great that there are data for questions around this potentially potent intervention for people with schizophrenia (for many treatments there are no data at all). I just cannot see that this approach (CBTp), on average, is reaping enough benefits for people.

Adams cites

Jones C, Hacker D, Cormac I, Meaden A, Irving CB. Cognitive behavioural therapy versus other psychosocial treatments for schizophrenia. Cochrane Database of Systematic Reviews 2012, Issue 4. Art. No.: CD008712.

Which concludes

Trial-based evidence suggests no clear and convincing advantage for cognitive behavioural therapy over other – and sometime much less sophisticated – therapies for people with schizophrenia.

Mark Taylor chaired the Scottish Intercollegiate Guidelines Network (SIGN) committee that produced the Scottish Guidelines for the Management of Schizophrenia. SIGN is the equivalent to the British National Initiative for Clinical Excellence (NICE). In an editorial in British Journal of Psychiatry he commented on the NICE guidelines’ favoring of cognitive behavioral therapy:

NICE has also taken the bold step of recommending CBT and family therapy alone for people with first-episode psychosis who wish it. The guideline acknowledges that psychosocial interventions are more effective in conjunction with antipsychotic medication, but still suggests this intervention alone for one month or less. This is controversial in view of the lack of robust supportive evidence and could potentially worsen outcomes. A related point is that in the guideline NICE seem oblivious to the fact that many patients with acute schizophrenia have impaired insight into their illness and health needs,5 and thus may not have capacity to consent to their treatment.

And finally, there is a Keith Laws’ carefully documented Science & Politics of CBT for Psychosis.

A Guardian story on mindfulness: New study shows mindfulness therapy can be as effective as antidepressants

Glass half-full readers, of course, will see that the trial results demonstrate that we actually have two similarly effective treatment options for recurrent depression: one involves eight weeks of a psychological therapy, the other relies on taking medication for two years. The challenge now is to make both equally available in treatment services.

I provided a detailed critique of this study. You would never guess from The Guardian article that mindfulness therapy used in this study was not designed to treat depression, only to prevent relapse in patients who had recovered in treatment by other means. And there was no assessment of whether patients assigned maintenance antidepressants were actually adhering to them or receiving adequate, guideline congruent care. You can see my comments on this study at PubMed Commons and leave your own as well.

The lead author of the study who is a colleague of the author of The Guardian went to the trouble of modifying the study registration to clarify that the trial was not designed to compare mindfulness therapy antidepressants for depression.

Feeling paranoid? Your worries are justified but can be helped

In this article The Guardian authors present as mainstream their unconventional views of what “feeling paranoid” represents. One of the authors promotes his own treatment for which he conducts workshops tied to his self-help books about worrying.

The fog machine gets going when the authors merge colloquial use of paranoid with the psychotic symptom. Many people, especially the young use “paranoid” in every speech in a way far removed from professionals discussing the psychotic symptom. Most endorsements of “feeling paranoid” on a checklist would not represent a psychiatric symptom. Even when present, the psychiatric symptom of paranoid is neither necessary nor sufficient for a diagnosis of schizophrenia.

When occurring in the context of a diagnosis of schizophrenia, however, paranoid delusions can be strongly held convictions accompanied by other lack of insight and thought disorder. I know of no evidence that everyday suspiciousness turns into psychotic persecutory delusions in persons who are not otherwise at risk for psychosis.

Think of someone insisting on shifting a conversation about skin cancer to talking about moles. Dropping lung cancer and chronic obstructive pulmonary disease for a more inclusive, but nonspecific “cough.” These are silly moves in a language game that prevent evaluation of health problems in terms of available evidence of necessity tied to more precise language.

The Guardian authors propose:

As we’ve noted previously on Guardian Science, anti-psychotics don’t work for everyone. And their side effects can be so unpleasant that many people refuse to take them. Moreover, there’s compelling evidence to suggest that the concept of “schizophrenia” doesn’t stand up scientifically, operating instead as a catch-all for a variety of distinct and frequently unrelated experiences.

What compelling evidence? Says who? I doubt that the one of these authors who is in the Psychology at Oxford would make such a statement in a formal presentation to his colleagues. But apparently it suffices for a lay audience including mental health services users seeking information about their condition and available treatments.

In general, readers should beware of authors making such sweeping statements in the media without identifying specific sources, degree of scientific consensus, or grade of evidence. The Guardian authors require readers to turn off critical skills and trust them.

This is why scientists have increasingly focused on understanding and treating those experiences in their own right, rather than assuming they’re simply symptoms of some single (albeit nebulous) underlying illness. So what have we discovered by applying this approach to paranoia?

Which “scientists”? Where? Readers are again left trusting the expertise of The Guardian authors.

The authors are getting set to promote the treatment developed by one them for “worry” in patients with paranoid delusions, which is marketed in his workshops, using his self-help book. I previously reviewed this study in detail.

I concluded

  • The treatment was a low intensity variation of a self-help exercise using excerpts from The Guardian authors’ book.
  • The treatment of the control group was ill-defined routine care. Relying on this control group as the only comparison precluded evaluating whether the intervention was any better than a non-branded similar amount of attention and support.
  • The primary outcome was hopelessly confounded with nonspecific worrying or anxiety and inadequate to assess clinically significant changes in psychotic symptoms of paranoid delusions.

I could go on with examples from other articles in The Guardian. But I think these suffice to establish that mental health service users seeking reliable information can find themselves misled by stories in The Guardian. Readers who don’t have the time or feel up to the task of checking out what they read against what is available in the literature would do well to simply ignore what is said in The Guardian about serious mental disorder and its treatment.

insect parts-page-0Readers advisory

Despite The Guardian having won the Pulitzer Prize for science reporting, readers may find stories about mental health that are seriously misleading and of little use in making choices about mental health problems and treatments. Information about these issues are not responsibly vetted or fact checked.

Whatever happened to responsible journalism at The Guardian?

in April 2015,The Guardian announced a Live Question and Answer Session.

How can academics help science reporters get their facts straight?

Academics have never been under more pressure to engage with the public and show the impact of their work. But there’s a problem. The media, one of the key channels for communicating with people outside academia, has a reputation for skewing or clumsily confusing scientific reports.

The session was in response to larger concerns about the accuracy of health and science journalism. With serious cutbacks in funding and layoffs of experienced professional journalists, the media increasingly rely upon copy/pasting exaggerated and inaccurate press releases generated by self-promoting researchers in the universities. What has been lost is the important filter function by which journalists offer independent evaluation of what they are fed by researchers’ public relations machines.

Many readers of The Guardian probably did notice a profound shift from reliance on professional journalists to to blogging provided free by academics. Accessing a link to The Guardian provided by a Google Search or Twitter, readers are given no indication that they will be reading a blog.

A blog post last year by Alastair Taylor identified the dilemma –

Media outlets, such as the Guardian Science Blogs, can present the science direct (and without paying for it) from the experts themselves. Blogging also opens up the potential for the democratisation of science through online debates, and challenges established hierarchies through open access and public peer review. At the same time, can scientists themselves offer the needed reflection on their research that an investigative journalist might do?

In the case of these  authors appearing in The Guardian, apparently not.

The new system has obvious strengths. I look forward to reading regular blog posts by academic sources who have proved trustworthy such as Suzi Gage, Chris Chambers, or many others. They have earned my trust sufficiently for me to recommend them. But unfortunately, appearing in The Guardian no longer necessarily indicates that stories are scientificially accurate and helpful to consumers. We must suspend our trust in The Guardian and be skeptical when encountering stories there about mental health.

I sincerely hope that this situation changes.

NOTE

*The authors of the PLOS One article cite a Nature article for this point, which states

More intelligent children demonstrate a particularly plastic cortex, with an initial accelerated and prolonged phase of cortical increase, which yields to equally vigorous cortical thinning by early adolescence. This study indicates that the neuroanatomical expression of intelligence in children is dynamic [bolding added].

 

Category: antipsychotics, Cochrane Collaboration, cognitive behavioral therapy, evidence-supported, mental health care, National Institute for Health and Care Excellence, Psychiatry, psychosis, psychotherapy, schizophrenia | Tagged , , , , | Leave a comment

Developments in the Treatment of PTSD Nightmares

By Shaili Jain, MD
Posted: June 10, 2015

“What Dreams May Come: Treating the Nightmares of PTSD” was a blog post I published in November 2013. It remains a very popular post, which continues to receive many views and comments. Since publishing that post, I have received multiple questions from readers about treatments for nightmares. These queries reinforce, for me, just how distressing this symptom of nightmares is for individuals who live with PTSD.

In light of this, on 5/22/2015 I interviewed Dr. Murray Raskind about his pioneering work in the field of PTSD and the treatment of nightmares.

Murray A. Raskind, MD, is Director of the VA Northwest Network Mental Illness Research, Education and Clinical Center (MIRECC). He is also Professor and Vice-Chairman in the Department of Psychiatry and Behavioral Sciences at the University of Washington School of Medicine and Director of the University of Washington Alzheimer’s Disease Research Center.

In the late 1990’s, Dr. Raskind pioneered the use of prazosin for nightmares, by giving it to some of his veteran patients with PTSD. What started as clinical innovation eventually morphed into an important research question, and in 2013 Dr. Raskind and his group reported on an encouraging scientific development. They conducted a fifteen week randomized controlled trial of prazosin that involved sixty-seven active duty soldiers with PTSD. The medicine was titrated up based on the participant nightmare response over a period of six weeks. Prazosin was found to be effective in improving PTSD nightmares and sleep quality in two thirds of the sample. It was also associated with the study participants reporting a reduction in PTSD symptoms and an improvement in their overall global functioning.

 

I started my interview by asking Dr. Raskind about any other scientific findings that have emerged from that trial since his 2013 publication.

 

Image: Coalitionforveterans.org

Image: Coalitionforveterans.org

Dr. Raskind: We did an interesting secondary analysis, which we are writing up for publication now, of that sample of 60 or so active duty Iraq/Afghanistan soldiers with PTSD. When we analyze the response to prazosin, prazosin worked a lot better than placebo, but not in everybody. Approximately 2/3 of the soldiers were moderately improved globally, but there were 1/3 who just did not respond even though there were no differences in their symptom severity as measured by the CAPS (The Clinician-Administered PTSD Scale). With just looking at the psychiatric symptomatology, we really could not differentiate why one person would respond and another would not. We started thinking about it and we thought it would be nice to know something about the level of activation in the brain of the alpha 1 receptor for norepinephrine, which is the target of . (Prazosin is an alpha 1 norepinephrine receptor blocker or antagonist.)

We were thinking maybe you had to have a lot of alpha 1 receptor stimulation by norepinephrine to be a responder and maybe there are different underlying biologies to the PTSD symptoms. Unfortunately, there is no way, using imaging technology or anything else, to directly measure the alpha 1 receptor for norepinephrine. But it occurred to me, having been interested in effects on blood pressure of norepinephrine, that the central norepinephrine system and the peripheral sympathetic nervous system, which uses norepinephrine as its neurotransmitter, are often co-regulated. Blood pressure particularly is affected strongly by stimulation of the alpha 1 receptor on the arterial blood vessels that regulate blood pressure.

We hypothesized that soldiers with PTSD who have higher standing systolic blood pressure would have a better response to prazosin than the ones with lower baseline standing systolic blood pressure. We did this before we started them on prazosin, because we were looking for a biomarker of response to prazosin or a predictor of response to prazosin. We just did a straight forward statistical analysis and, lo and behold, the prediction was strongly supported by the data. These are young men and their mean age is 29 and they were in good shape, because they were still in the army, so they have to keep physically fit. We did not have people with a systolic of 180, but if you just compare it, in the statistical model, a person who had a slightly elevated systolic blood pressure of 130, those folks have a big prazosin response. A big improvement. Whereas if you have a baseline standing systolic of 110, your response to prazosin did not differ at all from placebo.

 

Dr. Jain: So you are starting to paint a profile of what kind of patient would respond well to prazosin?

 

Dr. Raskind: Right, which goes to our clinical experience….I often get referred the most agitated, aggravated, and upset combat veterans with PTSD who are having sleep disruption. When they wake up from a nightmare, or even without a nightmare, the bed is wet from sweat and their heart is racing and they cannot get back to sleep. During the day they are hyper vigilant and irritable. The ones I see, the ones who are good prazosin responders, almost always have some degree of elevated blood pressure. When someone comes in to my office with the same clinical picture but their blood pressure is below normal, I say, “I do not think that prazosin is going to work particularly well for this veteran.” I made that observation clinically, but I did not know whether it was valid until we did the study. It is actually sort of exciting. We have to do it prospectively, but I think it will hold up. Even without measuring blood pressures, other indications of increased sympathetic arousal such as sweating when you wake up at night or during sleep is another factor that I think would be a good biomarker, but it is not so easy to quantify.

 

Dr. Jain: That is pretty exciting, because, as far as I know, when we look at medications for PTSD, I do not think we have other biological predictors of response.

 

Dr. Raskind: Right. We do not. That is correct. We presented the data at two places so far. At this year’s Biological Psychiatry meeting and also at ACNP (American College of Neuropsychopharmacology) last December.

 

Dr. Jain: How do you see prazosin being used in the clinical setting 5-10 years from now?

 

Dr. Raskind: Well, I think that I would like to see it being used for people in whom there is a good chance that it would work. It’s not for everybody. Fortunately, it is a pretty easy medication to tolerate and the side effects are relatively uncommon, provided that you start at a low dose and titrate it upwards. The titration should be based both on the target symptoms going away and if there are any adverse effects on blood pressure. Usually, adverse effects are relatively uncommon. The major problem with prazosin is that providers don’t titrate to a high enough dose. If you look nationally, there are about 100,000 veterans with a PTSD diagnosis in the VA who, last year, were prescribed prazosin. About, one out of six. But the downside is that the mean dose is about 4 milligrams.

 

Dr. Jain: Is that sub-therapeutic in your mind?

 

Dr. Raskind: It works for some people, but some people need more. They also often need smaller daytime doses. Either one in the mid-morning and another one at around mid-afternoon somewhere, in addition to the night time dose, because prazosin only has a duration of action of about 6-8 hours. There is no magic number of milligrams. In the 2013 study, we titrated it up to a maximum dose of 20 milligrams at night and 5 milligrams mid-morning. You could go that high. Rules were you titrate it up until all nightmares were gone in the previous week. It took a lot of prazosin. We got up to about a little over 15 milligrams at night and about 4 milligrams mid-morning until we reach that criterion. That suggests that 4 milligrams is too low. On the other hand, some people get better with 2 milligrams. Sleeping great and nightmares are gone. That is the dose for them.

 

Dr. Jain: It sounds like you would like to see prazosin used in a more tailored fashion in people who have a profile which suggests it is more likely to work for them.

 

Dr. Raskind: Exactly. There are other disorders for which it appears that prazosin will also play a therapeutic role.

 

Dr. Jain: Like what?

 

Dr. Raskind: Well, there are three. The first is alcohol use disorder. Second is post mild traumatic brain injury or post-concussion migraine headache. The third is agitation aggression in Alzheimer’s disease and probably dementia in general.

 

Dr. Jain: Alright. Other than prazosin, what else do you like to use for nightmares? Are there any other things you have come across that you are particularly impressed by, non-pharmacological as well as pharmacological?

 

Dr. Raskind: The literature on nightmare psychotherapy is mostly from civilian trauma populations. I don’t know how well it translates over to (veterans)… There are specific nightmare psychotherapies, that I am frankly not terribly familiar with, e.g. imagery rehearsal. Changing the nature of the dream while you are awake and then seeing if that helps. Again, it helps in civilian trauma populations. The nice thing about psychotherapy, in my opinion, is if it is done well with a compassionate and interested person, they all work to some degree and their side effects are pretty low. In general, the psychotherapy along with rational pharmacotherapies is probably the way to go.

 

Dr. Jain: Please offer your perspectives re: clinical innovation in the 21st century? Is it harder for today’s physicians to innovate at the bedside? (too much regulation, oversight, paperwork, legal implications)

 

Dr. Raskind: And these guidelines, which are really, mostly, guesses.

 

Dr. Jain: You mean the clinical practice guidelines?

 

Dr. Raskind: Right. If you do not follow them, people worry that they are going to be called on it and I have seen it happen. The prazosin thing—what happened there was I was working with this Vietnam veterans group in 1995. From their descriptions of their symptoms it was clear that they were having an adrenaline storm at night. So I said, “What do people use to calm excess norepinephrine in the brain?” Block the beta receptor with propranolol! (It has been used for social anxiety, public speaking anxiety, or for performers who get nervous about a performance.) So I gave my first veteran propranolol—I was pretty safe in doing that because he had some hypertension too. He came in and said, “I am getting worse. My nightmares are even more intense.” I looked at the PDR and saw that Beta blockers do intensify dreams!

I did know, from some of the neuroendocrine work that I have been doing in Alzheimer’s, that the beta receptor for norepinephrine and the alpha 1 receptor sometimes had opposite effects, when stimulated or blocked, on various neuroendocrine systems. So I said, “Well if he is getting worse by blocking the beta receptor, maybe he will get better if I block the alpha 1 receptors.” I looked at the available alpha 1 receptor antagonists. Prazosin was the only one that had reasonable penetrance into the brain by its lipid solubility. So I said, “Let’s try prazosin.” The veteran gets better. He got better and dramatically improved. The second one dramatically improved too.

 

Dr. Jain: That’s a great story. That happened in 1995, do you see that happening nowadays?

 

Dr. Raskind: I think it can, if people have open minds. We are not going to change the bureaucratic system, but we need to be observing things rather than saying, “This expert says this and this one says that.” I mean, though it is all well and good and we have studies which demonstrate this and that, it is very important for us to remember our experience with the individual patient. What we thought, a guess of what might help and if we have some rational for doing it. People are so afraid to deviate from what someone says is the right thing to do that it (clinical innovation) may be happening less and less.

 

Dr. Jain: Yes. Keeping an open mind and, like you said, focusing on the individual patient experience.

 

Dr. Raskind: And talking to your colleagues. Anyway, I agree with you that we are tending to under appreciate the ability of clinical observation to give us productive leads in drug development.

Category: mental health care, Psychiatry, PTSD, research | Tagged , , , | Leave a comment

Is mindfulness-based therapy ready for rollout to prevent relapse and recurrence in depression?

By James Coyne PhD
Posted: May 20, 2015

Doubts that much of clinical or policy significance was learned from a recent study published in Lancet

Dog-MindfulnessPromoters of Acceptance and Commitment Therapy (ACT) notoriously established a record for academics endorsing a psychotherapy as better than alternatives, in the absence of evidence from adequately sized, high quality studies with suitable active control/comparison conditions. The credibility of designating a psychological interventions as “evidence-based” took a serious hit with the promotion of ACT, before its enthusiasts felt they attracted enough adherents to be able to abandon claims of “best” or “better than.”

But the tsunami of mindfulness promotion has surpassed anything ACT ever produced, and still with insufficient quality and quantity of evidence.

Could that be changing?

Some might think so with a recent randomized controlled trial reported in the Lancet of mindfulness-based cognitive therapy (MBCT) to reduce relapse and recurrence in depression. The headline of a Guardian column  by one of the Lancet article’s first author’s colleagues at Oxford misleadingly proclaimed that the study showed

freeman promoAnd that misrepresentation was echoed in the Mental Health Foundation call for mindfulness to be offered through the UK National Health Service –

calls for NHS mindfulnessThe Mental Health Foundation is offering a 10-session online course  for £60 and is undoubtedly prepared for an expanded market.

andrea-on-mindfulness

Patient testimonial accompanying Mental Health Foundation’s call for dissemination.

 

 

 

The Declaration of Conflict of Interest for the Lancet article mentions the first author and one other are “co-directors of the Mindfulness Network Community Interest Company and teach nationally and internationally on MBCT.” The first author notes the marketing potential of his study in comments to the media.

revising NICETo the authors’ credit, they modified the registration of their trial to reduce the likelihood of it being misinterpreted.

Reworded research question. To ensure that readers clearly understand that this trial is not a direct comparison between antidepressant medication (ADM) and Mindfulness-based cognitive therapy (MBCT), but ADM versus MBCT plus tapering support (MBCT-TS), the primary research question has been changed following the recommendation made by the Trial Steering Committee at their meeting on 24 June 2013. The revised primary research question now reads as follows: ‘Is MBCT with support to taper/discontinue antidepressant medication (MBCT-TS) superior to maintenance antidepressant medication (m-ADM) in preventing depression over 24 months?’ In addition, the acronym MBCT-TS will be used to emphasise this aspect of the intervention.

1792c904fbbe91e81ceefdd510d46304I would agree and amplify: This trial adds nothing to  the paucity of evidence from well-controlled trials that MBCT is a first-line treatment for patients experiencing a current episode of major depression. The few studies to date are small and of poor quality and are insufficient to recommend MBCT as a first line treatment of major depression.

I know, you would never guess that from promotions of MBCT for depression, especially not in the current blitz promotion in the UK.

The most salient question is whether MBCT can provide an effective means of preventing relapse in depressed patients who have already achieved remission and seek discontinuation.

Despite a chorus of claims in the social media to the contrary, the Lancet trial does not demonstrate that

  • Formal psychotherapy is needed to prevent relapse and recurrence among patients previously treated with antidepressants in primary care.
  • Any less benefit would have been achieved with a depression care manager who requires less formal training than a MBCT therapist.
  • Any less benefit would have been achieved with primary care physicians simply tapering antidepressant treatment that may not even have been appropriate in the first place.
  • The crucial benefit to patients being assigned to the MBCT condition was their acquisition of skills.
  • That practicing mindfulness is needed or even helpful in tapering from antidepressants.

We are all dodos and everyone gets a prize

dodosSomething also lost in the promotion of the trial is that it was originally designed to test the hypothesis that MBCT was better than maintenance antidepressant therapy in terms of relapse and recurrence of depression. That is stated in the registration of the trial, but not in the actual Lancet report of the trial outcome.

Across the primary and secondary outcome measures, the trial failed to demonstrate that MBCT was superior. Essentially the investigators had a null trial on their hands. But in a triumph of marketing over accurate reporting of a clinical trial, they shifted the question to whether MBCT is inferior to maintenance antidepressant therapy and declared the success demonstrating that it was not.

We saw a similar move in a MBCT trial  that I critiqued just recently. The authors here opted for the noninformative conclusion that MBCT was “not inferior” to an ill-defined routine primary care for a mixed sample of patients with depression and anxiety and adjustment disorders.

An important distinction is being lost here. Null findings in a clinical trial with a sample size set to answer the question whether one treatment is better than another is not the same as demonstrating that the two treatments are equivalent. The latter question requires a non-inferiority design with a much larger sample size in order to demonstrate that by some pre-specified criteria two treatments do not differ from each other in clinically significant terms.

Consider this analogy: we want to test whether yogurt is better than aspirin for a headache. So we do a power analysis tailored to the null hypothesis of no difference between yogurt and aspirin, conduct a trial, and find that yogurt and aspirin do not differ. But if we were actually interested in the question whether yogurt can be substituted for aspirin in treating headaches, we would have to estimate what size of a study would leave us comfortable with that conclusion the treating aspirin with yogurt versus aspirin makes no clinically significant difference. That would require a much larger sample size, typically several times the size of a clinical trial designed to test the efficacy of an intervention.

The often confusing differences between standard efficacy trials and noninferiority and superiority trials are nicely explained here.

Do primary care patients prescribed an antidepressant need to continue?

Patients taking antidepressants should not stop without consulting their physician and agreeing on a plan for discontinuation.

NICE Guidelines, like many international guidelines, recommend that patients with recurrent depression continue their medication for at least two years, out of concerned for a heightened risk of relapse and recurrence. But these recommendations are based on research in specialty mental health settings conducted with patients with an established diagnosis of depression. The generalization to primary care patients may not be appropriate best evidence.

Major depression is typically a recurrent, episodic condition with onset in the teens or early 20s. Many currently adult depressed patients beyond that age would be characterized as having a recurrent depression. In a study conducted at primary care practices associated with the University of Michigan, we found that most patients in waiting rooms identified as depressed on the basis of a two stage screening and formal diagnostic interview had recurrent depression, with the average patient having over six episodes before our point of contact.

However, depression in primary care may have less severe symptoms in a given episode and an overall less severe course then the patients who make it to specialty mental health care. And primary care physicians’ decisions about placing patients on antidepressants in primary care are typically not based upon a formal, semi structured interview in which there are symptom counts to ascertain whether patients have the necessary number of symptoms (5 for the Diagnostic and Statistical Manual-5) to meet diagnostic criteria.

My colleagues in Germany and I conducted another relevant study in which we randomized patients to either antidepressant, behavior therapy, or the patient preference of antidepressant versus behavior therapy. However, what was unusual was that we relied on primary care physician diagnosis, not our formal research criteria. We found that many patients enrolling in the trial would not meet criteria for major depression and, at least by DSM-IV-R criteria, would be given the highly ambiguous diagnosis of Depression, Not Otherwise Specified. The patients identified by the primary care physicians as requiring treatment for depression were quite different than those typically entering clinical trials evaluating treatment options. You can find out more about the trial here .

It is thus important to note that patients in the Lancet study were not originally prescribed antidepressants based on a formal, research diagnosis of major depression. Rather, the decisions of primary care physicians to prescribe the antidepressants, are not usually based on a systematic interview aimed at a formal diagnosis based on a minimal number of symptoms being present. This is a key issue.

The inclusion criteria for the Lancet study were that patients currently be in full or partial remission from a recent episode of depression and have had at least three episodes, counting the recent one. But their diagnosis at the time they were prescribed antidepressants was retrospectively reconstructed and may have biased by them having received antidepressants

Patients enrolled in the study were thus a highly select subsample of all patients receiving antidepressants in the UK primary care. A complex recruitment procedure involving not only review of GP records, but advertisement in the community means that we cannot tell what the overall proportion of patients receiving antidepressants and otherwise meeting criteria would have agreed to be in the study.

The study definitely does not provide a basis for revising guidelines for determining when and if primary care physicians should raise the issue of tapering antidepressant treatment. But that’s a vitally important clinical question.

skeptical-cat-is-fraught-with-skepticismQuestions not answered by the study:

  • We don’t know the appropriateness of the prescription of antidepressants to these patients in the first place.
  • We don’t know what review of the appropriateness of prescription of antidepressants had been conducted by the primary care physicians in agreeing that their patients participate in the study.
  • We don’t know the selectivity with which primary care physicians agreed for their patients to participate. To what extent are the patients to whom they recommended the trial representative of other patients in the maintenance phase of treatment?
  • We don’t know enough about how the primary care physicians treating the patients in the control groups reacted to the advice from the investigator group to continue medication. Importantly, how often were there meetings with these patients and did that change as a result of participation in this trial? Like every other trial of CBT in the UK that I have reviewed, this one suffers from an ill defined control group that was nonequivalent in terms of the contact time with professionals and support.
  • The question persists whether any benefits claimed for cognitive behavior therapy or MBCT from recent UK trials could have been achieved with nonspecific supportive interventions. In this particular Lancet study, we don’t know whether the same results could been achieved by simply tapering antidepressants assisted by a depression care manager less credentialed than what is required to provide MBCT.

The investigators provided a cost analysis. They concluded that there were no savings in health care costs of moving patients in full or partial remission off antidepressants to MBCT. But the cost analysis did not take into account the added patient time invested in practicing MBCT. Indeed, we don’t even know whether the patients assigned to MBCT actually practiced it with any diligence or will continue to do after treatment.

The authors promise a process analysis that will shed light on what element of MBCT contributed to the equivalency of outcomes with the maintenance of antidepressant medication.

But this process analysis will be severely limited by the inability to control for nonspecific factors such as contact time with the patient and support provided to the primary care physician and patient in tapering medication.

The authors seem intent on arguing that MBCT should be disseminated into the UK National Health Services. But a more sober assessment is that this trial only demonstrates that a highly select group of patients currently receiving antidepressants within the UK health system could be tapered without heightened risk of relapse and recurrence. There may be no necessity or benefit of providing MBCT per se during this process.

The study is not comparable to other noteworthy studies of MBCT to prevent remission, like Zindel Segal’s complex study . That study started with an acutely depressed patient population defined by careful criteria and treated patients with a well-defined algorithm for choosing and making changes in medications. Randomization to continued medication, MBCT, or pill placebo occurred on in the patients who remitted. It is unclear how much the clinical characteristics of the patients in the present Lancet study overlapped with those in Segal’s study.

What would be the consequences of disseminating and implementing MBCT into routine care based on current levels of evidence?

There are lots of unanswered questions concerning whether MBCT should be disseminated and widely implemented in routine care for depression.

One issue is where would the resources come from for this initiative? There already are long waiting list for cognitive behavior therapy, generally 18 weeks. Would disseminating MBCT draw therapists away from providing conventional cognitive behavior therapy? Therapists are often drawn to therapies based on their novelty and initial, unsubstantiated promises rather than strength of evidence. And the strength of evidence for MBCT is not such that we could recommend substituting it for CBT for treatment of acute, current major depression.

Another issue is whether most patients would be willing to commit not only the time for sessions of training and MBCT but to actually practicing it in their everyday life. Of course, again, we don’t even know from this trial whether actually practicing MBCT matters.

There hasn’t been a fair comparison of MBCT to equivalent time with a depression manager who would review patients currently receiving antidepressants and advise physicians has to whether and how to taper suitable candidates for discontinuation.

If I were distributing scarce resources to research to reduce unnecessary treatment with antidepressants, I would focus on a descriptive, observational study of the clinical status of patients currently receiving antidepressants, the amount of contact time their receiving with some primary health care professional, and the adequacy of their response in terms of symptom levels, but also adherence. Results could establish the usefulness of targeting long term use of antidepressants and the level of adherence of patients to taking the medication and to physicians monitoring their symptom levels and adherence. I bet there is a lot of poor quality maintenance care for depression in the community

When I was conducting NIMH-funded studies of depression in primary care, I never could get review committees interested in the issue of overtreatment and unnecessarily continued treatment. I recall one reviewer’s snotty comment that that these are not pressing public health issues.

That’s too bad, because I think they are key in considering how to distribute scarce resources to study and improve care for depression in the community. Existing evidence suggest a substantial cost of treatment of depression with antidepressants in general medical care is squandered on patients who do not meet guideline criteria for receiving antidepressants or who do not receive adequate monitoring.

Category: antidepressants, depression, mindfulness, National Institute for Health and Care Excellence, primary care, psychotherapy, treatment as usual | Tagged , , , | 7 Comments