A Placebo-Controlled Trial of Phenelzine, Cognitive Behavioral Group Therapy, and Their Combination for Social Anxiety Disorder

Department of Psychiatry, New York State Psychiatric Institute, College of Physicians and Surgeons of Columbia University,1051 Riverside Dr, Box 69, New York, NY 10032, USA.
Archives of general psychiatry (Impact Factor: 13.75). 03/2010; 67(3):286-95. DOI: 10.1001/archgenpsychiatry.2010.11
Source: PubMed

ABSTRACT Medication and cognitive behavioral treatment are the best-established treatments for social anxiety disorder, yet many individuals remain symptomatic after treatment.
To determine whether combined medication and cognitive behavioral treatment is superior to either monotherapy or pill placebo.
Randomized, double-blind, placebo-controlled trial.
Research clinics at Columbia University and Temple University.
One hundred twenty-eight individuals with a primary DSM-IV diagnosis of social anxiety disorder.
Cognitive behavioral group therapy (CBGT), phenelzine sulfate, pill placebo, and combined CBGT plus phenelzine.
Liebowitz Social Anxiety Scale and Clinical Global Impression (CGI) scale scores at weeks 12 and 24.
Linear mixed-effects models showed a specific order of effects, with steepest reductions in Liebowitz Social Anxiety Scale scores for the combined group, followed by the monotherapies, and the least reduction in the placebo group (Williams test = 4.97, P < .01). The CGI response rates in the intention-to-treat sample at week 12 were 9 of 27 (33.3%) (placebo), 16 of 34 (47.1%) (CBGT), 19 of 35 (54.3%) (phenelzine), and 23 of 32 (71.9%) (combined treatment) (chi(2)(1) = 8.76, P < .01). Corresponding remission rates (CGI = 1) were 2 of 27 (7.4%), 3 of 34 (8.8%), 8 of 35 (22.9%), and 15 of 32 (46.9%) (chi(2)(1) = 15.92, P < .01). At week 24, response rates were 9 of 27 (33.3%), 18 of 34 (52.9%), 17 of 35 (48.6%), and 25 of 32 (78.1%) (chi(2)(1) = 12.02, P = .001). Remission rates were 4 of 27 (14.8%), 8 of 34 (23.5%), 9 of 35 (25.7%), and 17 of 32 (53.1%) (chi(2)(1) = 10.72, P = .001).
Combined phenelzine and CBGT treatment is superior to either treatment alone and to placebo on dimensional measures and on rates of response and remission.

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Available from: David M Fresco, Jul 04, 2015
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    ABSTRACT: According to cognitive-behavioral models of social anxiety disorder (SAD), four of the important maintaining mechanisms are avoidance, self-focused attention, anticipatory processing and post-event cognitive processing. Individual cognitive therapy (ICT) and cognitive behavioral group therapy (CBGT) both have substantial empirical support. However, it is unclear whether they achieve their effects by similar or different mechanisms. The aim of this study was to investigate whether changes in the four maintenance processes mediate clinical improvement in ICT and CBGT for SAD. We analyzed data from participants (N = 94) who received either ICT or CBGT in two separate RCTs. The results showed that ICT had larger effects than CBGT on social anxiety and each of the four potential mediators. More pertinently, moderated mediation analyses revealed significant between-treatment differences. Whereas improvement in ICT was mainly mediated by reductions in avoidance and self-focused attention, improvement in CBGT was mediated by changes in self-focused attention and in anticipatory and post-event processing. These results support the importance of the putative mediators, but suggest that their relative weights are moderated by treatment type.
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Questions & Answers about this publication

  • David M Fresco added an answer in EMDR:
    Is an anti-depressive incompatible with EMDR?

    Does anyone know - based on scientific research or clinical experience - whether EMDR is incompatible with an anti-depressive? An acquaintance, Mrs. C., is on 15 mg Mirtazapine (almost the minimum dosage) to keep her extreme generalized anxiety somewhat between limits. In the past she had suffered a brief psychotic episode. Her therapist (Mrs. C. is still on the waiting-list) claims that being medication-free is an absolute condition for EMDR to be effective. To me the risk seems too big.

    David M Fresco · Kent State University

    The question presupposes that there is something special or different about EMDR.  In fact there is NOTHING special or different in EMDR.  It is nothing more than a form of exposure therapy and the eye-movements add no special value to it. Thus, a more appropriate question is whether ADM is appropriate to administer with exposure therapy.  The answer as with many things is "it depends."  I was involved with a NIMH funded clinical trial where patients received a combination of CBT with and without phenelzine for social phobia.  Combination treatment was better than monotherapy Grillo et al., 2010).  There is also the famous example of combination treatment of CBT with and without imipramine for panic disorder (Barlow et al., 2000; JAMA) where initially combined treatment looked better at the end of acute treatment but the monotherapy arms evidenced superior treatment durability.  The after the fact interpretation of Barlow's trial is that simultaneous combination therapy resulted in less durable treatment gains because the ADM led to ambiguous inhibitory learning during the exposure exercises in CBT.  Thus, the take home message here or for anyone considering EMDR is that it is one of several efficacious exposure therapies and that the eye movements add NOTHING, and I repeat NOTHING above and beyond competently administered exposure therapy.  I find it regrettable that EMDR is somehow seen as something different or possibly better than traditional exposure therapy when the evidence to the contrary is so greatly overwhelming.  

  • David M Fresco added an answer in Clinical Psychology:
    What are your best suggestions for screening social phobia and measuring it's changes during therapy?
    I want to screen social phobia among students and also measure the changes during SE therapy.
    David M Fresco · Kent State University
    Several individuals have chimed in about the LSAS. I have published several papers on this measure attesting to it's reliability and treatment sensitivity in both the original interview form and in the purely self-report form. In either form, the LSAS is excellent at case finding and in many trials, is often the primary outcome measure of treatment change.
  • David M Fresco added an answer in Psychiatry:
    Which type of treatment is more effective for a generalized anxiety disorder, pharmacotherapy or psychotherapy?
    Which type of treatment is more effective for a generalized anxiety disorder, pharmacotherapy or psychotherapy?
    David M Fresco · Kent State University
    Actually, there's pretty convincing evidence when the active treatment is exposure therapy that combined treatment might be worse. The evidence comes from a trial for panic disorder (Barlow et al., 2000 JAMA). In that five arm study, the combination of CBT and Imipramine looked better after acute care ended, but in the follow-up, CBT with placebo and monotherapy with CBT evidenced the most durable treatment gains. The interpretation of those findings was that active medication may have interfered with the durability of exposure therapy effects in the CBT by not completely providing inhibitory learning. We recently published a trial comparing monotherapy CBGT or phenelzine or their combination in the treatment of social phobia, where combined treatment did perform best.

    My interpretation of those findings though is that phenelzine was a tough medicine to get patients to agree to take and that many patients may have already failed trials of what were at the time newer medications. I've always thought that the patients in that trial may have been more severe or more treatment refractory at the outset.