Using “Nashville” to Demonstrate The Truth about Flashbacks

I think it would be fair to say that most mental health professionals groan when watching how mental illness is represented on T.V shows. Too often popular culture portrays the lives of individuals living with mental illness (or the symptoms of psychiatric disorders) in a one dimensional way that lacks nuance or, worse, is outright misleading and only serves to perpetuate the many myths and misperceptions about psychiatric illness that already exist in our society.


Image Credit: ABC

Image Credit: ABC

Last month, whilst watching episode 19 of Season 2 of the hit TV show Nashville, I could not help but be pleasantly surprised at the show’s careful depiction of the psychiatric symptom known as a “flashback.” In this episode the musical prodigy, Scarlett O’Connor, (played by the Australian actress Claire Bowen) experiences a flashback of childhood trauma whilst performing live on stage in front of tens of thousands of people.


Whilst the term “flashback” is used loosely in everyday culture to describe casual recollections of memories from earlier on in life, mental health professionals have a different definition of the word flashback. When we use the word flashback, we use it to describe a phenomenon where an individual experiences involuntary recurrent memories.  The experience is often sudden and usually a powerful re-experiencing of a past experience or elements of a past experience.  The term is used particularly when the memory is so intense that the person “relives” the experience, and this reliving contributes to a serious disruption in the person’s life.

From my perspective, as a Posttraumatic Disorder (PTSD) expert, I find this psychiatric symptom particularly fascinating as it is commonly associated with the traumatic experiences associated with PTSD.


Definition of flashback


2012-04-05-ptsd1In the DSM V, references to flashbacks are to be found under the heading that describes PTSD, i.e. it is a symptom typically associated with PTSD.  A flashback is an example of a dissociative reaction – i.e. when the individual feels or acts as if the traumatic events were recurring. Such reactions occur on a continuum, with the most extreme expression being a complete loss of awareness of one’s present surroundings

A related quote from DSM V: (please note, this text refers to the definition of flashback as it pertains to adults)


“The individual may experience dissociative states that last from a few seconds to several hours or even days, during which components of the event are relived and the individual behaves as if the event were occurring at that moment. Such events occur on a continuum from brief visual or other sensory intrusions about part of the traumatic event without loss of reality orientation, to complete loss of awareness of present surroundings.  These episodes, often referred to as “flashbacks” are typically brief but can be associated with prolonged distress and heightened arousal”


There are surprisingly few empirical publications on flashbacks and even fewer articles on the phenomenology of flashbacks. Flashbacks are a defining feature of posttraumatic stress disorder (PTSD), but there have been few studies of their neural basis. But the study of flashbacks is becoming important, as they are given an increasingly prominent role in the diagnosis of posttraumatic stress disorder .

Indeed, the precise definition or clinical nature of a flashback remains a matter of debate, even amongst neuroscientists and mental health professionals, and this was part of the reason I was so impressed with the depiction in Nashville.


What does it feel like to have a flashback?


If you were experiencing a flashback of a traumatic experience it could be so realistic that it feels as though you are living through the experience all over again. You experience the flashback in your mind, but may also feel the emotions and physical sensations – fear, sweating, smells, sounds, and pain – associated with the original trauma.

Flashbacks are often triggered by some kind of reminder of the original trauma; it can be something as simple as a sensory experience associated with the original trauma e.g. the scent of a particular perfume, the feel of raindrops on a wet day, or a sudden loud street noise.


I have witnessed patients who are having a flashback of psychologically traumatic memories and the depiction in Nashville was pretty authentic.


The Nashville episode was classic not only for the scenes that depicted the actual flashback, as experienced by Scarlett O’Connor, but the narrative leading up to the terrible event was equally compelling and authentic.  The weeks and months leading up to the “meltdown” on stage shows a Scarlett who is working hard on a serious music album; she writes about her complicated, and often tortured, relationship with her mother.  Whilst her creative output is good, the process has been stressful and she has isolated herself from her closest friends and her maternal uncle—the key emotional supports in her life.  She starts to take illegally diverted prescription stimulants to help her stay awake so she can finish the album, this combined with the stresses and strains of an intensive tour schedule start to take its toll.

Photo by ABCNetwork/YouTube (screen capture)

Photo by ABCNetwork/YouTube (screen capture)

The “trigger” for Scarlett is the surprise arrival of her mother when she is on tour in San Francisco. Her mother, Beverly, is the main perpertrator of her childhood abuse.  Initially Beverly is civil but we soon start to see the side of her which is emotionally abusive and physically intimidating toward Scarlett. Scarlett starts to experience brief flashbacks of childhood physical abuse and neglect where she was locked in cupboards for hours at a time with no food, water, or access to a bathroom. Startled by the flashbacks and under pressure to perform on stage she starts to consume alcohol to “deal” with the flashbacks.


This is common amongst individuals experiencing symptoms of posttraumatic stress – they “self medicate” their symptoms with alcohol or illicit drugs.  Unfortunately, intoxication often contributes to an overall worsening of symptoms, and this is what happens to Scarlett.


The weeks of stress, lack of sleep, and abuse of prescription stimulants combined with the pressure of performing on stage and a grueling tour schedule make her susceptible to experiencing mental health distress. The arrival of her mother in “real life,” who is the perpetrator of the childhood abuse, combined with Scarlett’s alcohol intoxication triggers a horrifically intense flashback which, unfortunately, occurs whilst she is on stage.

The episode is particularly valuable as it shows the experience of a flashback from Scarlett’s perspective. She is no longer the country music star performing on stage for a live audience, she is a seven year old girl, locked in a closet, terrified for her life as she listens to her mother full of rage, ranting and raving outside the door.  As a result Scarlett behaves that way, retreating from light and noise and eventually curling up under her grand piano.

There are problems with the storyline – the episode is tactlessly titled, “Crazy” and Scarlett’s brief “hospitalization” where she is admitted to “get everything out of her system” returns the storytelling to the familiar levels of inaccurate and overly simplistic portrayals of mental illness that I am used to groaning and moaning about.  Nonetheless, when it comes to mental health issues in TV shows, Scarlett’s performance scene was a refreshingly truthful depiction of a flashback, and one that I had nothing to groan about.

Category: Commentary, Psychiatry, PTSD, Uncategorized | Tagged , , , | Leave a comment

Are meta-analyses done by promoters of psychological treatments as tainted as those done by Pharma?

We would not waste time with a meta-analysis from Pfizer claiming the superiority of its antidepressant. Particularly when it’s a meta analysis of trials mostly done by Pfizer. Bah, just another advertisement. What, the review was published? And without a declaration of conflict of interest? We would should be outraged and doubt the integrity of the review process.

If we were not distrustful already, Ben Goldacre’s Bad Pharma taught us to distrust a drug company’s evaluation of its own product. Most randomized drug trials are industry funded. In these trials, the sponsor’s drug almost always triumphs. Overall, industry funded placebo-controlled trials of psychotropic medication are five times more likely to get positive results than those free of such funding.

My colleagues and I have successfully pushed for formalizing what was previously informal and inconsistent: in conducting a meta-analysis, source of funding for an RCT should routinely be noted in the evaluation using the Cochrane Collaboration  risk of bias criteria. Unless this risk of bias is flagged, authors of meta-analyses are themselves at risk for unknowingly laundering studies tainted by conflict of interest and coming up with seemingly squeaky clean effect sizes for the products of industry.

Of course, those effect sizes will be smaller if industry funded trials are excluded. And maybe the meta analysis would have come to a verdict of “insufficient evidence” if they are excluded.

My  colleagues and I then took aim at the Cochrane Collaboration itself. We pointed out that this had been only inconsistently done in past Cochrane reviews. Shame on them.

They were impressed and set about fixing things and then gave us the Bill Silverman Award. Apparently the Cochrane Collaboration is exceptionally big on someone pointing out when they are wrong and so they reserve a special award for who does it best in any given year.

Bill Silverman was a founding member of the Cochrane collaboration and pointed out thatcertified pain in the ass lots of people were making supposedly evidence-based statements that were wrong. That is why some sort of effort like Cochrane collaboration was needed. Silverman was a certified troublemaker. Our getting the award certifies us as having made trouble. I am taking that as a license to make some more.

Meta-analyses everywhere, but not a critical thought…

What is accepted as necessary for drug trials is routinely ignored for trials of psychotherapy treatments and meta-analyses integrating their results. Investigator allegiance has been identified as one of the strongest predictors of outcomes, regardless of the treatment that is being evaluated. But this does not get translated into enforcement of disclosures of conflict of interests by authors or by readers having heightened skepticism.

Yet, we routinely accept claims of superiority of psychological treatments made by those who profit from such advertisements. Meta-analyses allow them to make even bigger claims than single trials. And journals accept such claims and pass them on without conflict of interest statements. We seldom see any protesting letters to the editor. Must we conclude that no one is bothered enough to write?

Meta-analyses of psychological treatments with undisclosed conflicts of interest are endemic. We already know investigator allegiance is a better predictor of the outcome of the trial than whatever is being tested. But this embarrassment is explained away in terms of investigator’s enthusiasm for their treatment. More likely, results are spurious or inflated or spun.  There is high risk of bias associated with investigators having a dog in the fight. And a great potential for throwing the match with flexible rules of data selection, analysis, interpretation (DS, A, and I). And then there is hypothesizing after results are known (HARKING).

It is scandalous enough that the investigators can promote their psychological products by doing their own clinical trials, but they can go further, they can do meta-analysis. After all, everybody knows that a meta-analysis is a higher form of evidence, a stronger claim, than an individual clinical trial.

Because meta-analyses are considered the highest form of evidence for interventions, they provided an important opportunity for promoters to brand their treatments as evidence-supported. Such a branding is potentially worth millions in terms of winning contracts from governments for dissemination and implementation, consulting, training, and sale of materials associated with the treatment. Readers need to be informed of potential conflict of interest of the authors of meta-analyses in order to make independent evaluations of claims.

And the requirement of disclosure ought to apply to reviewers who act as gatekeepers for what gets into the journals. Haven’t thought of that? I think you soon will be. Read on.

This will be the first of two posts concerning the unreliability of a meta-analysis done by authors benefiting from the perception of their psychological treatment, Triple P Parenting Programs (3P) as “evidence-supported.” By the end of the second post, you will see how much work it takes to determine just how unreliable the meta-analysis is and how inflated an estimate it provides of the efficacy and effectiveness of 3P. Maybe you will learn to look for a few clues in examining other meta-analyses. But at least you will have learned to be skeptical.

nothing_to_declare1No conflict of interest statement was included with the article. Nothing_to_DeclareFurthermore, the bulk of the participants included were from studies in which investigators got financial benefits from a positive outcome, including very often one or more authors of this particular meta-analysis.

Nothing said in the article, but an elaborate statement was made in the preregistration of the meta-analyses at International Prospective Register of Systematic Reviews (PROSPERO) CRD42012003402 [Click on statement to enlarge.]

conflict of interest

Many journals, like PLOS One routinely remind editors and reviewers to consult preregistration and be alert to any discrepancies between the details of the preregistration and the published article, which are common and need to be clarified by the authors. Apparently this was not done.

goods to declare_redIt is not that Clinical Psychology Review lacks a policy nothing to declareconcerning conflict of interest.

All authors are requested to disclose any actual or potential conflict of interest including any financial, personal or other relationships with other people or organizations within three years of beginning the submitted work that could inappropriately influence, or be perceived to influence, their work. See also Further information and an example of a Conflict of Interest form can be found at:

Interlude: What we learn from the example of 3P, we can apply elsewhere

In the early days of the promotion of acceptance and commitment therapy (ACT), small-scale studies produced positive results at a statistically improbable rate, because of DS, A, and I and HARKING. Promoters of ACT therapy then conducted a meta-analysis that was cited in claims made to Time Magazine that ACT was superior to established treatments. Yet, in the short time since I blogged about this, it has become apparent that ACT is not superior to other credible, structured therapies. Promoters’ praise of ACT continues to depend disproportionately on small, methodologically inadequate studies that very often they themselves conducted.

But promoters of ACT really do not need to worry. They are off doing workshops and selling merchandise. In the workshops, they often show dramatic interventions like crying with patients that are not demonstrated to be integral to any efficacy of ACT but that are sure crowdpleasers.

And their anecdotes and testimonials often involve applications of ACT that are off label, i.e., not supported by studies of similar patients with similar complaints. They have gotten the point that workshops are not primarily about “how to” and “when to” but about drama and entertainment. They have learned from Dr. Phil.

But no one’s going to revoke their uber alles evidence-supported branding.

In a future post, I will show the same phenomenon is beginning to be seen with mindfulness therapy. There was already an opening shot at this in my secondary blog.

I am sure there are other examples. What is different about 3P is the literature is huge and the issue of conflict of interest has now been so squarely placed on the table.

In this and the next post, I will show meta-analysis as self-promotion on a grand scale. And I will begin my analysis with a juicy tale of misbehavior by editors, reviewers, and authors.

I hope the story will anger those interested in the integrity of the literature concerning psychological treatments, be they promoters, policymakers, taxpayers footing the bill for treatment, or consumers who are often receiving treatment because it is mandated.

Why you should not be reading meta-analyses…unless …

Analyses of altmetrics suggest when most people find an interesting study with an internet search, most get only as far as abstracts, not downloading and reading articles. But chances are that they form opinions about those articles based solely on the reading of the abstract.

In the case of meta-analyses, forming independent opinions can take multiple reads and application of critical skills guided by healthy dose of skepticism. And maybe going back to the original studies.

If you do not have the time, the skills, and the skepticism, you should not be reading meta-analyses. And you should not be accepting what you find in abstracts.

Should you stop reading meta-analyses?

Suspend judgment. Let me lay out for you a critical analysis and see if you would be willing to undertake it yourself. Or simply walk away, asking “WTF, why bother?”


Triple P Parenting is described by its developers

The Triple P – Positive Parenting Program is one of the most effective evidence-based parenting programs in the world, backed up by more than 30 years of ongoing research. Triple P gives parents simple and practical strategies to help them confidently manage their children’s behaviour, prevent problems developing and build strong, healthy relationships. Triple P is currently used in 25 countries and has been shown to work across cultures, socio-economic groups and in all kinds of family structures.

They proudly proclaim its branding as evidence supported–

No other parenting program in the world has an evidence base as extensive as that of Triple P. It is number one on the United Nations’ ranking of parenting programs, based on the extent of its evidence base.

An ugly and incredible story

Along came Phil Wilson M.D., PhD. He tried to express skepticism but he got slapped down.

He sent off manuscript describing a meta-analysis to Clinical Psychology Review. The manuscript noted how little evidence that was for the efficacy of 3P that was not tainted by investigator conflict of interest.

It is reasonable to presume that someone associated with the promoters of 3P was invited to review his manuscript.

  • The author’s employer was contacted and informed that Wilson had written a manuscript critical of 3P.
  • The manuscript was savaged.
  • Promoters of 3P sent Wilson some studies that had been published after the period covered by his meta-analysis.
  • The journal refused Wilson’s request for ascertainment of whether reviewers had disclosed conflicts of interest.

Wilson filed a formal complaint with the Committee on Publication Ethics (COPE). You can read it here and the letter from COPE to Clinical Psychology Review here.

Wilson’s rejected manuscript was nonetheless published in BMC Medicine. I praised it in a blog post, but noted that it had been insufficiently tough on the quality and quantity of the studies cited in widely touted branding of 3P has evidence supported. With Linda Kwakkenbos, I then wrote the blog post as an article that appeared in BMC Medicine.

Wilson’s meta-analysis

The meta-analysis is well reasoned and carefully conducted, but scathing in its conclusion:

In volunteer populations over the short term, mothers generally report that Triple P group interventions are better than no intervention, but there is concern about these results given the high risk of bias, poor reporting and potential conflicts of interest. We found no convincing evidence that Triple P interventions work across the whole population or that any benefits are long-term. Given the substantial cost implications, commissioners should apply to parenting programs the standards used in assessing pharmaceutical interventions.

My re-evaluation

My title says it all: Triple P-Positive Parenting programs: the folly of basing social policy on underpowered flawed studies.

My abstract

Wilson et al. provided a valuable systematic and meta-analytic review of the Triple P-Positive Parenting program in which they identified substantial problems in the quality of available evidence. Their review largely escaped unscathed after Sanders et al.’s critical commentary. However, both of these sources overlook the most serious problem with the Triple P literature, namely, the over-reliance on positive but substantially underpowered trials. Such trials are particularly susceptible to risks of bias and investigator manipulation of apparent results. We offer a justification for the criterion of no fewer than 35 participants in either the intervention or control group. Applying this criterion, 19 of the 23 trials identified by Wilson et al. were eliminated. A number of these trials were so small that it would be statistically improbable that they would detect an effect even if it were present. We argued that clinicians and policymakers implementing Triple P programs incorporate evaluations to ensure that goals are being met and resources are not being squandered.

You can read the open access article, but here is the crux of my critique

Many of the trials evaluating Triple P were quite small, with eight trials having less than 20 participants (9 to 18) in the smallest group. This is grossly inadequate to achieve the benefits of randomization and such trials are extremely vulnerable to reclassification or loss to follow-up or missing data from one or two participants. Moreover, we are given no indication how the investigators settled on an intervention or control group this small. Certainly it could not have been decided on the basis of an a priori power analysis, raising concerns of data snooping [14] having occurred. The consistently positive findings reported in the abstracts of such small studies raise further suspicions that investigators have manipulated results by hypothesizing after the results are known (harking) [15], cherry-picking and other inappropriate strategies for handling and reporting data [16]. Such small trials are statistically quite unlikely to detect even a moderate-sized effect, and that so many nonetheless get significant findings attests to a publication bias or obligatory replication [17] being enforced at some points in the publication process.

In response, promoters of 3P circulated on the Internet a manuscript that was labeled as being under review at Monographs of the Society for the Study of Child Development. The  manuscript is here. You can see that it explicitly cited Wilson’s meta analysis and my commentary.  But our main points are not recognizable.

Captured from Google Scholar

Click to enlarge


Many journals, including those of the American Psychological Association expressly forbid  circulating a manuscript with a label of it being under review at that particular journal. Perhaps that contributed to the rejection of the manuscript. But it was resubmitted to Clinical Psychology Review and published – without any conflict of interest statement.

Here is the abstract to the abortive Monographs of the Society submission.

This systematic review and meta-analysis examined the effects of the multilevel Triple P-Positive Parenting Program system on a broad range of child, parent and family outcomes. Multiple search strategies identified 116 eligible studies conducted over a 33-year period, with 101 studies comprising 16,099 families analyzed quantitatively. Effect sizes for controlled and uncontrolled studies were combined using a random effects model for seven different outcomes. Moderator analyses were conducted using structural equation modeling. Risk of bias within and across studies was assessed. Significant short-term effects were found for: children’s social, emotional and behavioral outcomes (d = 0.473); parenting practices (d = 0.578); parenting satisfaction and efficacy (d = 0.519), parental adjustment (d = 0.340); parental relationship (d = 0.225) and child observational data (d = 0.501). Significant effects were found for all outcomes at long-term including parent observational data (d = 0.249). Separate analyses on available father data found significant effects on most outcomes. Moderator analyses found that study approach, study power, Triple P level, and severity of initial child problems produced significant effects in multiple moderator models when controlling for other significant moderators. Several putative moderators did not have significant effects after controlling for other significant moderators, including country, child developmental disability, child age, design, methodological quality, attrition, length of follow-up, publication status, and developer involvement. The positive results for each level of the Triple P system provided empirical support for a blending of universal and targeted parenting interventions to promote child, parent and family wellbeing.

It is instructive to compare the above abstract to what was subsequently published in Clinical Psychology Review. Presumably, they should be some differences arising from the manuscript having been peer-reviewed. The original manuscripts submitted as a monograph, and so it is length had to be cut to conform to the limits of Clinical Psychology Review. But if you compare the two, some obvious flaws in the original manuscript were retained in the published version. Obviously, peer review was deficient in not noticing them and otherwise leaving little mark on the final, published version.

Unfortunately, the subsequent Clinical Psychology Review article is behind a pay wall. But you can write to the senior author at and request a PDF. But here is the abstract:

This systematic review and meta-analysis examined the effects of the multilevel Triple P-Positive Parenting Program system on a broad range of child, parent and family outcomes. Multiple search strategies identified 116 eligible studies conducted over a 33-year period, with 101 studies comprising 16,099 families analyzed quantitatively. Moderator analyses were conducted using structural equation modeling. Risk of bias within and across studies was assessed. Significant short-term effects were found for: children’s social, emotional and behavioral outcomes (d = 0.473); parenting practices (d =0.578); parenting satisfaction and efficacy (d = 0.519), parental adjustment (d = 0.340); parental relationship (d = 0.225) and child observational data (d = 0.501). Significant effects were found for all outcomes at long-term including parent observational data (d = 0.249). Moderator analyses found that study approach, study power, Triple P level, and severity of initial child problems produced significant effects in multiple moderator models when controlling for other significant moderators. Several putative moderators did not have significant effects after controlling for other significant moderators. The positive results for each level of the Triple P system provide empirical support for a blending of universal and targeted parenting interventions to promote child, parent and family wellbeing.

Impressive, hey? Certainly the effect sizes are and they contrast sharply with Wilson. If you had not been sensitized by my blog post, would you be inclined to simply accept the conclusion that is conveyed that the meta-analysis produces resounding support for 3P?

You would never know it from the abstract, but effect sizes from nonrandomized studies were combined with effect sizes from RCTs. But RCTs with head comparisons bs.etween 3P and other active treatments had the comparison groups dropped, so that the studies were considered not to be RCTs.

I do hope that you form your own opinion by obtaining a copy of the full article. You can also compare it to the PROSPERO registration.

Within 10 days of today, May 20, 2014,I will be posting my critique and we can compare notes.

A much briefer version of this blog post was previewed at my secondary blog. It was narrowly focused on the scandalous events concerning Wilson’s manuscript and not the larger context of how we view meta-analyses conducted by authors who have vested financial interest.

Category: Uncategorized | Tagged , , , | 8 Comments

U.S. Mental Health Policy Comes of Age

I am delighted to offer Mind the Brain readers a guest blog written by Keith Humphreys, Ph.D.  Dr. Humphreys is a Professor and the Section Director for Mental Health Policy in the Department of Psychiatry and Behavioral Sciences at Stanford University. He is also a Senior Research Career Scientist at the VA Health Services Research Center in Palo Alto and an Honorary Professor of Psychiatry at the Institute of Psychiatry, King’s College, London. His research addresses the prevention and treatment of addictive disorders, the formation of public policy, and the extent to which subjects in medical research differ from patients seen in everyday clinical practice.

Dr. Humphreys has been extensively involved in the formation of public policy, having served as a member of the White House Commission on Drug Free Communities, the VA National Mental Health Task Force, and the National Advisory Council of the U.S. Substance Abuse and Mental Health Services Administration. During the Obama Administration, he spent a sabbatical year as Senior Policy Advisor at the White House Office of National Drug Control Policy. He has also testified on numerous occasions in Parliament and advises multiple government agencies in the U.K.

Follow Professor Humphreys on Twitter @KeithNHumphreys.


U.S. Mental Health Policy Comes of Age


From the very first days of the U.S. health insurance system, the stigma of mental illness was formally codified into benefit design.  Both public and private insurers provided inferior coverage for mental health care, if they even provided it at all.  For decades, this was not remotely controversial.  Labor unions were quite happy to trade “mental for dental” when negotiating fringe benefits for their workers, politicians suffered no electoral consequences for passing insurance legislation that discriminated against people with mental illness, and families who needed better health benefits for mentally ill loved ones were typically too ashamed to speak up.  But thanks to brave advocates, inspiring bipartisan political leadership and cultural changes in perceptions of mental illness, dramatically improved mental health insurance coverage has at last arrived on the American scene.


Three laws have transformed the landscape of mental health insurance policy in the span of only a half-decade.


MedicareIn 2008, a sweeping reform of Medicare passed which righted an injustice that had plagued the program since its inception.  Medicare originally covered outpatient mental health and addiction treatment at a far lower rate (50%) than other outpatient care (80%).  The backbreaking 50% outpatient co-pay effectively prevented most enrollees from accessing outpatient mental health care.  The 2008 law phased this payment disparity out over time, eliminating it entirely as of January 1, 2014.  Medicare now covers 80% of outpatient mental health care costs, which is good news for its 50 million current enrollees and the 150,000 new enrollees it gains each month.


Attribution: Titomuerte at en.wikipedia; Photographer Mischa Fisher, Mental Health Parity Rally, March 5th 2008.

Attribution: Titomuerte at en.wikipedia; Photographer Mischa Fisher, Mental Health Parity Rally, March 5th 2008.

Also in 2008, Congress passed and President G.W. Bush signed the Wellstone-Domenici Mental Health Parity and Addiction Equity Act. Named for its two leading Senatorial advocates (interestingly, the proudly liberal Paul Wellstone and the staunchly conservative Pete Domenici) the law requires companies with more than 50 employees as well as Medicaid managed care plans to make their offered mental health benefits comparable to those for other illnesses.  These parity protections apply to over 100 million Americans.


Image Credit: Pete Souza

Image Credit: Pete Souza

The 2010 Affordable Care Act aka “Obamacare” went even further. It extended parity protections to individuals who receive insurance from small businesses and to those who purchase it in the individual market (e.g., on a state or federal health insurance exchange).  It also defines mental health as an essential health care benefit that all plans it regulates must offer.  Last but not least, the law of course also provides insurance to the uninsured population, which has a high rate of psychiatric disorders.  Over 60 million Americans will receive improved mental health insurance coverage because of the provisions of the Affordable Care Act.


Although enormous work remains necessary to implement these laws, they together bring the U.S. closer than it has ever been to providing mental health treatment on demand.  Coping with mental illness is never going to be easy, but at least mental health policy is now directed at making the process easier rather than harder.

Category: Commentary, mental health care, Uncategorized | Tagged , , | 2 Comments

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

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 , , , , | Leave a comment

On bitopertin and sharing data from clinical trials

While modern antipsychotics are doing an OK job improving the positive symptoms of schizophrenia – such as auditory hallucinations or fixed delusional ideas – there is a lot left to be desired in term of how these medications – or any psychotropics for that matter – work against negative symptoms. colorful-pillsThe negative symptoms of schizophrenia, including deficits in a variety of mental functions such as will power, ability to enjoy things, express emotions, or associate with others, have been an elusive target from a treatment perspective. In other words, available medications for schizophrenia might help a patient deal with “the voices,” but, because they do not also improve that patient’s negative symptoms, his ability to return to a meaningful and productive life is not substantially helped.

A promising new medication for negative symptoms — almost

Not surprisingly, any intervention that promises to improve negative symptoms makes the news. This was exactly what happened with bitopertin, a new Roche medication aimed at negative symptoms, which generated enough enthusiasm during its preliminary testing (Phase I and II clinical trials) to move to Phase III trials.

So, one wonders, why didn’t a brand new bitopertin study ( identifier NCT00616798), with a solid design and impressive action on negative symptoms get any attention – from the media, psychiatrist gurus, patient’s advocates, anyone? The study, which just came out in the flagship psychiatric journal (JAMA Psychiatry) generated no press/media coverage that I am aware off.

Actually, this rather surprising silent treatment is not an accident.

It turns out that this study has been preempted by a press announcement that Roche made this last January stating that  bitopertin did not hold up to its promise following its Phase III testing.  Meaning that… the just published JAMA Psychiatry study — the very study which generated enough enthusiasm to justify the seemingly well-deserved promotion bitopertin received further down the pipeline — is old, outdated news.

To summarize: on one hand, great positive results from a just published study, which, as it turns out, are actually quite old. On the other hand, negative results in Phase III testing, according to a news conference, but no publications to date.

The result: bitopertin is at the center of what is essentially a skewed and likely misleading state of affairs – at least from the point of view of official scientific validation via publication in peer reviewed journals.

How did we get here?

It seems that this bitopertin situation is the predictable result of a series of unfortunate events including:

  1. delays in reporting NCT00616798 study results : the original study, according to the official data, was completed in February 2010, more than 3 1/2 years prior to submission for  publication (original submission date August 30, 2013)
  2. an extremely lengthy peer review process: only a bit shy of 1/2 year: the original submission date was August 30, 2013; final revision received January 24, 2014; accepted January 24, 2014.
  3. No shared public data for any of the relevant studies that have been completed.

There is a fairly straightforward solution to prevent such complications: opening up the data from clinical trials to the public.alltrials_basic_logo2 Europe is already  pursuing an initiative to make reporting of all clinical trials data mandatory. This is an important step forward. But real progress will not occur unless and until patient level data is made available to the general public as close in time as possible to the date of data collection completion. Adrian Preda, M.D.

Category: mental health care, Publication bias, research, schizophrenia | Tagged , | 5 Comments