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“Complex, multi-component therapy” can be studied well

This August was a tough month for SBM bloggers reading The New England Journal of Medicine (NEJM). Just one week after a review of acupuncture for back pain—in which the authors recommended referring patients to traditionally trained acupuncturists despite data showing that traditional needling does not outperform a blinded sham control (click here here here for the trifecta takedown)— NEJM featured an original article about a study of Tai Chi for fibromyalgia. As critiqued by Dr. Gorski, the control intervention for the Tai Chi study was arguably inappropriate: the test and control groups experienced different intensities of exercise, for different durations of time, led by different instructors with different levels of enthusiasm. The special pleading and the weak design were not of themselves surprising, only their presence in such an august journal.

A group of editorial authors in that same NEJM issue preemptively address the SBM critics by describing Tai Chi as a “complex, multi-component therapy” and thereby implying that an appropriate sham cannot easily be designed. I agree that studying Tai Chi must be trickier than matching drugs to sugar pills. But “complex, multi-component” interventions can indeed be studied in a way that leads to convincing conclusions, as illustrated in the August 25, 2010 issue of The Journal of the American Medical Association (JAMA). A team of Boston psychologists studied a complex, multi-component intervention for attention deficit-hyperactivity disorder (ADHD) and reported their findings in “Cognitive Behavioral Therapy vs Relaxation With Educational Support for Medication-Treated Adults With ADHD and Persistent Symptoms: A Randomized Controlled Trial.” The abstract:

Context Attention-deficit/hyperactivity disorder (ADHD) in adulthood is a prevalent, distressing, and impairing condition that is not fully treated by pharmacotherapy alone and lacks evidence-based psychosocial treatments.
Objective To test cognitive behavioral therapy for ADHD in adults treated with medication but who still have clinically significant symptoms.
Design, Setting, and Patients Randomized controlled trial assessing the efficacy of cognitive behavioral therapy for 86 symptomatic adults with ADHD who were already being treated with medication. The study was conducted at a US hospital between November 2004 and June 2008 (follow-up was conducted through July 2009). Of the 86 patients randomized, 79 completed treatment and 70 completed the follow-up assessments.
Interventions Patients were randomized to 12 individual sessions of either cognitive behavioral therapy or relaxation with educational support (which is an attention-matched comparison).
Main Outcome Measures The primary measures were ADHD symptoms rated by an assessor (ADHD rating scale and Clinical Global Impression scale) at baseline, posttreatment, and at 6- and 12-month follow-up. The assessor was blinded to treatment condition assignment. The secondary outcome measure was self-report of ADHD symptoms.
Results Cognitive behavioral therapy achieved lower posttreatment scores on both the Clinical Global Impression scale (magnitude –0.0531; 95% confidence interval [CI], –1.01 to –0.05; P = .03) and the ADHD rating scale (magnitude –4.631; 95% CI, –8.30 to –0.963; P = .02) compared with relaxation with educational support. Throughout treatment, self-reported symptoms were also significantly more improved for cognitive behavioral therapy (β = –0.41; 95% CI, –0.64 to –0.17; P <001), and there were more treatment responders in cognitive behavioral therapy for both the Clinical Global Impression scale (53% vs 23%; oddsratio [OR], 3.80; 95% CI, 1.50 to 9.59; P = .01) and the ADHD rating scale (67% vs 33%; OR, 4.29; 95% CI, 1.74 to 10.58;P = .002). Responders and partial responders in the cognitive behavioral therapy condition maintained their gains over 6 and 12 months.
Conclusion Among adults with persistent ADHD symptoms treated with medication, the use of cognitive behavioral therapycompared with relaxation with educational support resulted in improved ADHD symptoms, which were maintained at 12 months.

Cognitive behavioral therapy (CBT) is a psychotherapeutic intervention based on teaching patients to recognize, challenge, and consciously correct their maladaptive thoughts and behaviors. It has strongest evidenciary support in the treatment of mild to moderate depressive disorders, either alone or in combination with medical therapy. CBT is also sometimes used in the treatment of anxiety disorders, obsessive-compulsive disorder, personality disorders, and somatoform disorders. This focused therapy involves teaching patients to change easily identifiable thoughts and behaviors; it does not address or even presuppose any unconscious factors in the psychological disorder.

The details between the JAMA ADHD study and the NEJM fibromyalgia study are similar in several ways. Both studies address a condition of uncertain etiology, pervasive impact on a patient’s personal life, subjective measurability, and unsatisfactory response to medical treatment. (The latter is not always true for ADHD, but it was true by selection in this study.) Both studies examined a therapy that is non-medical, non-surgical and requires a trained therapist; in both cases the intervention had somatic and cognitive components, albeit in different mixtures, as well as a didactic component. Both studies refrained from overly restrictive inclusion criteria, allowing patients with different degrees of disease and medication history so long as no patient had experienced the therapy under study, thereby maximizing generalizability.

And yet, compared to questionable sham of the NEJM study of Tai Chi (as described), the JAMA study of CBT had a very interesting control intervention. The test group had 12 one-on-one sessions of CBT, which included: education about the disease ADHD, organizational and planning strategies that compensate for ADHD symptoms, specific skills to increase concentration and reduce distractibility, and learning to think differently about the disease symptoms and triggers. The control group had an equal number of sessions of equal duration; they also were educated about ADHD, but in place of CBT they were taught progressive muscle relaxation (PMR) and practiced applying the techniques in response to ADHD symptoms. PMR is the process of sequentially tensing and relaxing specific muscle groups, and along with other techniques it can be an effective tool for reducing anxiety. Since anxiety is not thought to play a major role in ADHD, we can reasonably assume that PMR will not yield specific therapeutic effects for the study participants.

The problem with the Tai Chi control group is that it failed to control for the very types of nonspecific effects that the SBM critics suspect are most responsible for the perceived effectiveness of CAM: time spent with a caring professional focusing on your symptoms and performing an elaborate ritual. If you compare a “boring” sham with an “exotic” intervention, then you have not controlled for important placebo effects. Here are two examples of CAM shams that successfully control for these elements, and the resulting data are negative. The brilliance of the CBT study is that PMR controls for many of these nonspecific effects of the therapeutic interaction: a 50-minute session, one-on-one with the therapist, focused on noticing and responding differently to your symptoms. Furthermore, the CBT and PMR therapies were both conducted by the same individual psychologists (no confounding for a charismatic Eastern mystic!) who were trained before the study in both interventions and sporadically monitored for adherence. This CBT study should be held up as an example of how to properly evaluate a “complex, multi-component” therapeutic intervention.

Finally, there is good news from this study not just for SBM fans but also for our friends and patients who suffer from ADHD. The data from this study suggest that CBT can cause meaningful and durable improvement in symptoms of adult ADHD that is poorly controlled by medical therapy. Patients with ADHD who need an alternative or a complement to medical therapy need not look outside the realm of evidence-based treatment.

As a fourth-year medical student applying right now to psychiatry residency programs, I look forward to learning more about evidence-based psychotherapies like CBT.

Posted in: Clinical Trials

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