Project Leader Dave Claud, an addiction specialist and all around good guy, asked me to take a look at a recent article extolling the virtues of Suboxine for opioid addiction.

Weiss, R., et al. (2012). Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence. Archives of General Psychiatry, 68 (12), 1238-1246.

This is an interesting article and on first pass, it seems like a reasonable look at the relative merits of medication management with buprenorphine-naloxone (Suboxone) v. the same with an additional counseling component. But on further inspection, the spin on the results is an unabashed marketing of Suboxone to primary care docs. First, and foremost, the results are simply atrocious. The study had 2 phases: a two week “treatment lite” version (2 weeks of meds with a 2 week taper off the med followed by a 7 week follow up) and an up to 24 week more intensive regimen (12 weeks of meds followed by a 3 week taper and a 7 week follow up). In the first phase, only 6.6% of participants achieved successful outcomes; in the second phase, only 8.6% achieved a successful outcome. Holy Cow! The additional counseling mattered not: no differences in outcome between conditions. But before I get to that, and there is likely a pretty good reason for it, let’s address the spin on this study.

In the second phase, following 12 weeks of the meds (of course you know this an opioid agonist that approximates but does not offer the full package of actual opioid use because of the addition of a one quarter antagonist), there was a 49.2% successful outcome which all but evaporated after the med was tapered off. So the spin is that as long as you keep prescribing the Suboxone, nearly half of patients will successfully stay off prescription opioids. But if you stop, nearly all of those who benefit will ultimately start using again. So Suboxone, in essence, and without saying it directly, is promoted as a life-long treatment for opioid addiction that any physician can do in primary practice. A scary thought to be sure, and certainly a conclusion that benefits you know who. That’s the spin. But what won’t be in the sound bites here is that the medication management condition included weekly appointments with docs and weekly discussion of addiction, abstinence, and other psychiatric and substance abuse issues as well as the recommendation of self help groups. So the medication management condition already included a counseling component, although a less intensive one—a 20 minute meeting as opposed to the 60 minute meetings in the counseling condition. It is not likely that primary care physicians in the real world would every do the medication management component of the treatment and would wind up just prescribing the Suboxone, which is likely the bottom line message here.

Now, I am not saying that counseling added anything better because it didn’t. It seems like the counseling was pretty much the traditional, psychoeducational medical model, 12 step variety with a skill building component around life skills and relapse prevention. It just didn’t add much to what the doc provided and perhaps was seen as superfluous by the patient after talking to the doc and getting the drug. In essence it was counseling lite (by a doc who is giving you drugs) vs. a more intensive counseling experience. I wonder what giving the drug v. therapy would have done. I don’t think it was a very good effort to show what therapy can provide a person with an opioid addiction .

Several take home points: first of all opioid addiction (oxycodone, hydrocodone, hydromorphone, morphine, codeine, propoxyphene, etc), virtually created by free prescribing practices of primary care docs and anesthesiologists for pain etc, promoted heavily by drug companies is perhaps the mother of all addictions in terms of difficulty to treat. It exceeds heroin addiction in scope by at least 20 times. Perhaps it is the ultimate irony that the treatment advocated is to be administered by the same primary care docs who got us into this mess to start with. So the pharmaceutical industry has created this monster problem and now has a solution for it. I hope that we can figure out a better way than keeping a person on Suboxone. Because, besides the less than exemplary results, 83% experienced 1 or more adverse events in Phase 1 and 60% in Phase 2 (most common were headache and constipation). It is interesting that percentages of all the side effects are presented until we get to the “serious adverse events (SAE).” In Phase1, there were 12 SAEs (just 2 weeks of med treatment) or 1.8% experienced an SAE but when the med treatment continued for 12 weeks, 6.7% of patients experienced a severe adverse reaction. So the risks increase as time on the meds increase.

It is a complicated picture of a very difficult problem. Call me jaded but it is hard for me to not to see this article (whose authors have many ties to pharmaceuticals) as purely a marketing effort.

That’s my take.

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Consider the reach of CDOI/PCOMS: PCOMS and/or CDOI are recognized by two states (Arizona and Colorado) as an evidence based treatment and PCOMS is currently under review by SAMHSA for national evidence based treatment designation. PCOMS has been implemented by hundreds of organizations, public and private, by thousands of behavioral healthcare professionals in all 50 states and 20 countries serving over 100,000 clients a year. I think it is safe to say that CDOI and PCOMS are becoming a part of the vernacular of providing mental health and substance abuse services.

The Norwegian-American research team (Jesse Owen, Morten Anker, Jacqueline Sparks and Barry Duncan) has scored again, our fourth article based on the massive Norway Couple Feedback Study. Our article, “Initial Relationship Goal and Couple Therapy Outcomes at Post and Six Month Follow Up” has been accepted for publication in the Journal of Family Psychology. This study shows the benefits of knowing what couples want to accomplish in therapy at the outset as well as how couple therapy can help folks regardless of their goals of wanting to improve the relationship or get out of it. It is based on the scale developed by Morten Anker as well as his experience with couples wanting a variety of different things from therapy. Most if not all research in couple therapy deals with couples who desire to improve their relationship but that only covers a portion of the couples we see in real life. This study addresses that reality. It confirms the common sense notion that couples wanting to improve their relationship get better outcomes and are more likely to be together at follow up than couples in which one or both individuals are seeking clarification regarding the viability of the relationship. Moreover, it also demonstrates that couple therapy can benefit clients regardless of their initial goal. We conclude that therapist awareness of each individual’s relationship goal prior to couple therapy could enhance outcomes and treatment tailored according to initial goals could set the stage for positive outcomes however defined.

Jesse Owen, who is now a Project Leader, is doing a webinar via the member site on January 27 about these issues (Become a CDOI Member to participate):

The Couple Therapy that Nobody Talks About: Ambivalence, Commitment, and Change
This webinar discusses couple therapy in which at least one partner is ambivalent about the viability of the relationship. Commitment is vital for couples to successfully develop a secure emotional base and maintain a healthy relationship. When commitment wavers it affects nearly all aspects of the relationship, such as communication, couple identity, willingness to sacrifice, as well as respect, trust, and safety. Treating couples with wavering commitment is rarely discussed in either the theoretical or empirical literature. This webinar covers: (a) cutting-edge research on the importance of assessing couples’ initial relationship goals as a facet of the working alliance; (b) a theoretical framework to understand couples’ commitment; and (c) treatment guidelines for treating couples when at least one partner desires to clarify the viability relationship.

Two other items of interest: A brief video about On Becoming a Better Therapist that I did at APA: http://www.apa.org/pubs/books/interviews/4317217-duncan.aspx

And an interview I did with an old friend from graduate school who hosts a radio show:
http://www.clientdirectedoutcomeinformed.com/media/mp3/Wake_Up_Call_2011-11-20.mp3

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International Society for Ethical Psychology and Psychiatry Position Paper By Dr. Jacqueline Sparks, Project Leader, Heart and Soul of Change Project

The American Academy of Pediatrics (AAP) recently updated their guidelines for the diagnosis and treatment of attention-deficit/hyperactivity disorder (ADHD) to include preschool children (www.pediatrics.org/cgi/doi/10.1542/peds.2011-2654 ). The lowered age limit for treatment in the new AAP guidelines inevitably will increase the use of stimulant medications for this vulnerable age group. The use of these drugs and diagnoses of ADHD continue to rise (http://psychiatryonline.org/cgi/content/abstract/appi.ajp.2011.1103038). The numbers are sure to swell as pediatricians are given the green light to prescribe psychostimulants for very young patients.

Treatment related evidence for the AAP clinical ADHD practice guidelines relied on a recent review prepared by the Agency for Healthcare Research and Quality (AHRQ) (Charach, 2011). This review examined 15 reports representing 11 investigations of the use of psychostimulants by preschoolers and claimed that studies found the drugs to be safe and efficacious. However, the review acknowledges that “the evidence comes primarily from short-term trials lasting days to weeks with small samples” (p. Es-8). When comparing methylphenidate with parent behavior training (PBT), the review concludes that the strength of evidence for use of PBT was high due to number of studies and consistency of results but low for methylphenidate because of only one good-quality study (The Preschool ADHD Treatment Study, PATS). While PATS found modest differences on endpoint measures between the drug and placebo, only 21% of best-dose methylphenidate achieved defined criterion for remission set for school-age children diagnosed with ADHD. Moreover, 30% of parents spontaneously reported moderate to severe adverse events in all phases of the study, including irritability, repetitive behaviors, tics, and emotional outbursts (Wigal et al., 2006). For those children who remained on medication, annual growth rates were 20.3% less than expected for height and 55.2% for weight (Swanson et al., 2006).

In 2006, the Drug Safety and Risk Management Advisory Committee of the FDA urged stronger warnings on ADHD drugs, citing reports of serious cardiac risks, psychosis or mania, and suicidality for children taking them. A review of past studies on the effect of ADHD drugs on children’s growth found that the drugs suppress both height and weight for the duration of the trials that were studied (Drappatz et al., 2006). Height and weight effects were noted by the AHRQ review. Moreover, the AHRQ review cites that “Evidence that psychostimulant use in childhood improves long-term outcomes was inconclusive” (p. vii). . . [and] the majority of studies examining the long-term safety and efficacy of ADHD drugs are industry-funded and may result in “enhanced representations of efficacy and safety” (p. ES-9). The report concludes: “The increasing use of off-label prescriptions [of ADHD drugs] for very young children is concerning . . . “There is one primary implication from the review . . . the first line intervention for young children [at risk of ADHD] is evidence-based PBT” (p. 171).

Based on their own investigation, opening the floodgates for ADHD medications for children under the age of 6 is not justified. In light of current evidence, the International Society for Ethical Psychology and Psychiatry (ISEPP) strongly opposes the new AAP Guidelines and urges the AAP to reconsider the implications for lowering the age for which ADHD drugs may be recommended. The ISEPP further urges the AAP to retract their new guidelines until such evidence surfaces that ADHD drugs provide an acceptable risk relative to their benefit for children under the age of 6.

For references, see full position paper at: http://heartandsoulofchange.com/resources/psychiatric-drugs/

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The Partners for Change Outcome Management System (PCOMS), otherwise known as CDOI, has jumped the first hurdle and is officially under review by NREPP (SAMHSA’s National Registry of Evidence-based Programs and Practices), and will soon be so designated on the NREPP website. This doesn’t guarantee that it will make the approved list but it looks very good given the research we have done, especially the RCTs (all three RCTs are available on the website). This will be, of course, quite a boon to the use of the ORS and SRS in everyday clinical practice and from my perspective quite a boost for involving clients as full partners in decisions that affect their care.

Speaking of research, there are several research projects that are in process: an RCT with returning veterans with PTSD related problems and substance abuse concerns is in the writing phase; an RCT with children with behavioral problems in the schools is in its second year of data collection; a comparison trial of residential treatment services with and without CDOI for clients with the “SMI” moniker is underway; an RCT with prescribers of psychotropic meds is in the planning stages; and a component study addressing why the feedback intervention works is also in the planning stages. I’ll keep you informed of the progress.

Along the lines of Sami Timimi’s “No More Psychiatric Labels” campaign to abolish diagnostic systems like ICD and DSM (Check it out at http://www.criticalpsychiatry.net/?p=527  Support the campaign at http://www.causes.com/causes/615071-no-more-psychiatric-labels/about), another project is underway that calls attention to the many pitfalls of the psychiatric diagnosis. I just signed their petition. Check it out: “Open Letter to the DSM-5″
http://www.ipetitions.com/petition/dsm5/?utm_medium=email&utm_source=system&utm_campaign=Send%2Bto%2BFriend

I really think this is an important cause, extremely well articulated, and I’d like to encourage you to add your signature, too. It’s free and takes just a few seconds of your time.

And, I want to call your attention to the Training of Trainers Conference in West Palm Beach, Florida from January 30 to February 3, 2012. There are still a few spots left so don’t miss out on this intense CDOI/PCOMS immersion as well as the fun and sun. I am convinced that the difference between successful and unsuccessful agency implementation boils down to having someone on site that knows the ins and outs of not only CDOI, but also the nuts and bolts of making it happen on an organizational level. Hope to see you there.

Finally, join me for this month’s webinar on ensuring data integrity and therapist understanding on November 23rd at 1PM Central. Join the member site to watch.

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The pharmaceutical industry has made it very difficult to know what the clinical trial evidence actually is regarding psychotropics. Consequently, primary care physicians and other front-line practitioners are at a disadvantage when attempting to adhere to the ethical and scientific mandates of evidence based prescriptive practice. This article calls for a higher standard of prescriptive care derived from a risk/benefit analysis of clinical trial evidence. The authors assert that current prescribing practices are empirically unsound and unduly influenced by pharmaceutical company interests, resulting in unnecessary risks to patients. In the spirit of evidenced based medicine’s inclusion of patient values as well as the movement toward health home, we present a patient bill of rights for psychotropic prescription. We then offer guidelines to raise the bar of care equal to the available science for all prescribers of psychiatric medications.

Join me for a webinar on this article on October 19th at 1PM Central. Join the member site to watch.

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I was recently asked by the magazine, The New Therapist (Issue 74) to addresss the following question:
How important is attention to, and/or interpretation of, transference and countertransference dynamics for successful outcomes in psychotherapy, and why?

My response: Attention to and/or interpretation of transference/countertransference is no more important, and no less, than any other therapist action derived from theory, model, or technique. All approaches tend to work equally well, a finding referred to as the “dodo verdict.” Moreover, model differences or “specific effects” (those aspects unique to a given approach) account for a small amount of the variance of change with an effect size (ES) of only .2. Putting this into perspective, a meta-analysis of the client’s perception of empathy found an ES of .32. This is not meant to denigrate transference/countertransference or any other model-based idea or technique but rather to suggest what Saul Rosenzweig concluded 75 years ago–given that all approaches appear to work about the same, there must be common factors that account for therapeutic change.

One such factor (originating from psychodynamic thinking) holds far more sway over outcome–the therapeutic alliance. There are over 1000 studies that support the association between a strong alliance and positive outcome. The alliance accounts for five to seven times the amount of variance attributed to model and technique. It transcends any specific therapist behavior and is a property of all. It functions to engage the client in purposive work and includes both a relational connection and an agreement about the goals and tasks of therapy. Importantly, the alliance is dependent on the delivery of some particular treatment—a framework for understanding and solving the problem. Technique–whether interpreting transference or challenging dysfunctional thoughts–is the alliance in action.

While there is no differential efficacy among approaches on aggregate, there is with the client in your office now. The question is: does it resonate or not? Does its application help or hinder the alliance? Does the client engage in the work and make meaningful changes when you attend to or make transference/countertransference interpretations?

The only way to answer this question is to risk our romance with our theories and secure client-based feedback about outcome and the alliance–a process now shown in nine RCTs to significantly improve outcomes regardless of the treatment administered. For example, the largest trial of couples therapy ever done found that clients who gave their therapists feedback about the outcome and alliance on two brief, four-item forms reached clinically significant change nearly four times more than non-feedback couples did .

The constructs of transference/countertransference have a storied history steeped in the tradition of psychoanalytic thinking. Approaches that hold these ideas dear are just as effective as those that don’t. Regardless of model, however, most therapists can increase their effectiveness substantially through identification of those clients who are not responding and addressing the lack of change in a way that keeps clients engaged and forges new directions. The evidence calls for a “new therapist,” a more sophisticated clinician who chooses from a variety of orientations and methods to best fit client preferences and cultural values based on feedback about the benefit and fit of services.

The Training of Trainers event is coming up quick.  Learn how to train others in CDOI and PCOMS! Escape the cold this winter and attend the Training of Trainers Conference in sunny Florida, January 30-February 3.

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Data Integrity, Agency Implementation, and More Research
My views about agency implementation have changed substantially in the last few years. I used to believe in allowing it to happen more organically with agencies coming to see how data collection was invaluable part of the CDOI/PCOMS implementation process. Implementation generally started with the practices that supported a client directed or client privilege process and then progressed to operationalizing client privilege with the ORS/SRS family of measures. And then, data collection would start. The problem is that when I would follow up and look at the data, it had no integrity—in short, it was not helpful to therapists or agencies. I now believe that implementation should start with data collection from the very beginning. Collecting data allows you know in a heartbeat who is doing it and who isn’t. It allows supervisors to attend data integrity issues—that the measures are being used properly—right from the get-go. The data provides a clear picture of fidelity and integrity. The major integrity issues to look for are: More than 30% over the clinical cutoff ; any scores between 35-40; and ORS scores are go up and down or look like a saw on a graph.
Here is a slide I made to reflect the importance of data.
div style=”width:425px” id=”__ss_9075706″> DataIntegrity