Archive for May, 2010

Can’t Make It Up This Good–or Bad: TEOSS Follow-Up


Sometimes, people don’t believe me when I talk about the evidence regarding psychotropic drugs. It does sound far-fetched some times because the evidence is so much different than what you hear in everyday conversation.  The difference between what you hear or read in the media and the clinical trial data is striking, so much so that reporting the real evidence often leads to raised eyebrows. But you know, I couldn’t make it up near as well or as damning as the actual clinical trial evidence. For example consider the latest about antipsychotics and kids.

Prescriptions for antipsychotics for children continue to skyrocket, despite underwhelming evidence. Here is how we wrote about the NIMH funded Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) (Sikich et al., 2008) in our recent chapter in the Heart and Soul of Change, 2nd Edition (Sparks, Duncan, Cohen, & Antonuccio, 2010):

“Described as a landmark trial (McClellan et al., 2007), TEOSS sought to examine the efficacy, tolerability, and safety of two second generation antipsychotics (SGAs; Risperdal and Zyprexa) for youths diagnosed with early-onset schizophrenia spectrum disorder and to compare these to a first generation antipsychotic FGA (molindone or Moban). Fewer than 50% of subjects completed 8 weeks of treatment and response rates were low and not significantly different for all three groups (Sikich et al.). Participants in the study were allowed concomitant use of antidepressants, anticonvulsants, and benzodiazepines, compromising even these disappointing findings. A 17-year old boy committed suicide and an unspecified number of participants were hospitalized due to suicidality or worsening psychosis. These events are particularly disturbing in light of the fact that youths considered at risk for suicide were excluded from the study. Weight gain was deemed serious enough to warrant suspension of the Zyprexa arm (McClellan et al.).”

It gets better or should I say worse? Follow up, available on line and soon to be published in the June issue of Journal of the American Academy of Child & Adolescent Psychiatry (see the abstract at http://www.jaacap.com/article/S0890-8567(10)00294-7/abstract, revealed that only14 of the 116 youth (12%) responded to the medication and stayed on it for one year. That’s right, you read it correctly–12%! Recall that in the famous adult trial of antipsychotics (the CATIE trial) that 74% dropped out. So it is even worse in youth—88% failed to benefit.

So let’s break this down. First, TEOSS was not placebo-controlled. The 116 youth enrolled into the trial were randomized either to a first generation antipsychotic (Moban) or to an atypical antipsychotic or so called second generation antipsychotic (Risperdal and Zyprexa). At the end of eight weeks, the response rate was 50% for those treated with Moban, 46% for Risperdal, and 34% for Zyprexa. Adverse events were “frequent” in all three groups.

Only those youth who “responded” during the initial eight weeks — 54 of the 116 — were entered into the 44-week maintenance study. Forty of the 54 youth dropped out during this period because of “adverse effects” or “inadequate response.” Thus, only 14 of the 116 youth who entered the study responded to the medication and stayed on it for as long as one year—only 12%.

Pharmacotherapy helps some children and adolescents, although apparently not very many. However, the preponderance of empirical research indicates that the risk may not be worth it. While pharmacotherapy involves considerable risk for young people, psychosocial interventions have a strong track record with virtually no adverse associated medical events. APA’s Working Group on Kids and Psychotropics (2006) concluded:

For most of the disorders reviewed herein, there are psychosocial treatments that are solidly grounded in empirical support as stand-alone treatments. Moreover, the preponderance of available evidence indicates that psychosocial treatments are safer than psychoactive medications. Thus, it is our recommendation that in most cases, psychosocial interventions be considered first. (p. 16. Italics added)

As the evidence regarding TEOSS suggests, the automatic prescription of antipsychotics for sure, but with any psychotropic, is unwarranted. Where children are concerned, the stakes are higher. They are, essentially, mandated clients—most do not have a voice to say no to treatments or devise their own, and depend on adults to safeguard their wellbeing (Sparks & Duncan, 2008). If you are seeing kids taking antipsychotics, you are on very firm ground to raise concerns and ensure the treatment is fitting client preferences.

Read more about psychiatric drugs and the evidence at http://heartandsoulofchange.com/resources/psychiatric-drugs/

 

Vatican Update: Psychiatric Drugs and the Directory


Many of you have asked me for a Vatican Update. Sorry it has been so long but this has been and will likely continue to be a long term process that requires a sustained effort to reach success. As you know, Jacqueline Sparks and I continue our efforts (see our chapter in the new Heart and Soul) to encourage folks to consider the risk/benefits of psychiatric drugs and our conclusion that the data do not support drugs as a first line intervention or rising prescription rates. This of course does not mean that we are anti drug or anti psychiatry but rather that we challenge automatic prescription, and believe that clients should have access to information, informed consent, and a range of alternatives that honor their preferences—and have the ability to monitor the results.

And many of you know that I did a radio show on Voice America about this same issue with Marcia Barbacki and David Cohen (many episodes available at http://heartandsoulofchange.com/resources/audio-presentations/ ). Marcia is the most persistent and selfless person I know. She works tirelessly at her own expense to bring this controversial topic to mainstream awareness and her efforts over the past three years have focused on enlisting the Catholic Church to help stem the tide of rising prescriptions, especially to kids given they have little voice in such decisions. I was intrigued and inspired by the idea that the Church and her vessels could counter the forces of corporate power and greed. Few institutions or even governmental entities seem to be able to stand up to economic tsunami of the pharmaceuticals…over 40 billion in sales last year and more spent on marketing than on research and development; and there is a pharmaceutical lobbyist assigned to every member of congress. Remember that good marketing, and unlimited lobbying, can overcome bad data every single day of week. Knowing that, I couldn’t help but be smitten by the idea that if the Church could be persuaded that the evidence does not support the prescription rates especially with children, considering the risks, then, through all the channels available—religious communities, churches, and schools—they might promote a cautionary, no first line use stance , and call for each professional to look at the evidence him or herself as well as a more defined separation between the pharmaceutical industry and research/education. For a great article about the negative effects of blurring this distinction as well as recommendations to fix the influence of drug companies on research and education, see Marcia Angell’s excellent article at: http://bostonreview.net/BR35.3/angell.php. This is not a wide eyed anti drug zealot but rather a former editor of the New England Journal of Medicine. I hope that this article might convince you that we are not just conspiracy theorists!

Marcia Barbacki and I recently did a presentation in Lourdes, France—a place that is inspiring on many levels—to an international group of Catholic physicians, nurses, pharmacists, and other health care professionals. Check out this presentation available in PowerPoint for your free download as well as the narrative summary at a new page of articles about psychotropics: http://heartandsoulofchange.com/resources/psychiatric-drugs/. The video from the presentation will be available soon. It will at the least be entertaining because I am wearing a suit and look like a fish out of water or perhaps like Gomer Pyle in his Sunday best. Golly! Marcia’s efforts and the presentation paid off. I am presenting at the Vatican’s annual conference in November. This could lead to an international conference on this important topic. Keep your fingers crossed.

And speaking of kids and drugs, Jacqueline just sent me this music video on ADHD:

And now for something completely different: I also wanted to remind you about the CDOI Directory. The benefits of listing will only increase over time as it becomes more known. Traffic to the site is increasing and will continue as other things develop including upcoming press releases about the alliance article as well as Networker and Psychotherapy in Australia articles. Besides allowing others to find you and know that you aspire to CDOI ideas and practices, it will allow you to network with folks holding similar values about practice, perhaps allowing you to find a local community. It can also provide additional exposure of your practice and let potential funders, interns, volunteers, etc, know of you and your interests. Over time, I hope to let funders know of our list and the benefits that members can offer because of their attention to client benefit and the alliance. And Rebecca just added another feature. You can download the CDOI Registered Provider icon from your listing and place it on your website to inform your visitors of your membership in the directory and what it means.

I am hoping for 100 members by the time of the Heart and Soul of Change Conference so I can show it to folks. I would appreciate your consideration. And while you are considering that, consider coming to the conference!

 

Alliance Trumps Early Change, The Mailing List, and a New Webinar


I am very pleased to announce that our alliance article from the Norway Feedback Project (Anker, Owen, Duncan, & Sparks, in press) was accepted in the prestigious Journal of Consulting and Clinical Psychology (JCCP). Congrats to the whole team: Morten Anker, Certified Trainer, Jesse Owen, Research Director, and Jacqueline Sparks, Project Leader. Although already well established in terms of its widespread use and validated psychometrics, this is a major step forward for the Session Rating Scale (our alliance measure), bringing it more academic credibility, and importantly, it allows mainstream scientific dissemination of the idea of continuous alliance monitoring. The Outcome Rating Scale/Session Rating Scale combo (or the Partners for Change Outcome Management System or PCOMS), btw, is the only outcome system that includes routine alliance monitoring. And the SRS is the only alliance measure specifically designed for the front line clinician for use with every client in every session.

There’s a lot of talk about what makes some therapists more effective than others, and a lot of claims unsubstantiated by research. But what really makes a difference in outcome is that tried and true but taken granted old friend, the alliance. The most definitive thing we know about what makes some therapists better than others is their ability to secure a good alliance across a variety of client presentations and personalities. This finding was recently confirmed by a sophisticated analysis by Scott Baldwin and colleagues in perhaps the premier psychotherapy research publication, JCCP. It also dispelled common folklore by demonstrating that good alliances were more of a function of what therapists brought to the table than clients; i.e., therapists adept at alliances were able to transcend type of client while other less effective therapists were not. Further, and simply put, the alliance accounts for five to seven times the amount of variance of outcome as model and technique. And, according to the bible of psychotherapy outcome research (Garfield and Bergin’s Handbook of Psychotherapy and Behavior Change, the Orlinsky, Rønnestad, and Willutzki chapter) there are over 1000 process-outcome findings that support the association between a strong alliance and positive outcome.

Despite this, however, naysayers (read model maniacs, I mean proponents) will dismiss the alliance by saying the research is only correlational. Even more damning, they say, is that we don’t know which comes first, client experience of a strong alliance or client report of change or benefit—the classic chicken or the egg question. Enter our just accepted alliance study that involved a total sample of 500 clients. The alliance significantly predicted outcome over and above early change, demonstrating that the alliance is not merely an artifact of client improvement but rather a force to be reckoned with in and of itself. Don’t let anyone tell you that the alliance is anything less than it is—the single greatest impact we can have on client change. We can continually improve our ability to form strong alliances with a broader range of clients, and thereby improve our effectiveness. Don’t leave it to change. Monitor with your clients.

A new feature just added to the website: The Heart and Soul of Change Project Mailing List. This list won’t cover you up in email or leave you hurling harsh language at me—I promise. You will only receive 4-6 updates per year about the latest training opportunities and Project happenings.  Subscribe/unsubscribe or change your profile.

Finally, the next webinar is scheduled:

Have you ever wondered how to present client directed outcome informed (CDOI) ideas and practices to a general rather than professional audience? Wonder no longer, because that is what I did in my self help book, What’s Right With You and that’s what this webinar will do:

We live in a world pervaded by the unspoken attitude that we are all basically flawed, broken, incomplete, scarred or sick: we’re labeled as dysfunctional, codependent, depressed, you name it. Contrary to popular perception and drug company ad campaigns, fifty years of research shows that positive change does not primarily emerge from examining the disorders, diseases, or dysfunctions—all the stuff that’s wrong with us—that allegedly plague the masses. Change, in truth, comes from what’s right with the people attempting it—their strengths, resources, ideas, and relational support—not the labels they are branded with, the special expertise of doctors or the magic methods or potions they peddle.

In this webinar Barry translates CDOI into a six step plan, as detailed in his self help book, What’s Right With You.

Title: What’s Right With You by Barry Duncan
Date: Friday, May 28, 2010
Time: 12:00 PM – 1:00 PM CDT

Join the CDOI Members or wait until this webinar is posted on the bookstore.