Article

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: 14.48). 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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    • "Cognitive behavioral group therapy (CBGT) has been shown to be effective in the treatment of SAD in at least 12 randomized controlled trials (e.g. Blanco et al., 2010; Heimberg et al., 1990). Access to treatment is however limited (Cavanagh, 2013) and stigma, costs, and difficulty to take time off from work to attend therapy sessions are common barriers to treatment (Mewton, Smith, Rossouw, & Andrews, 2014; Moritz, Schroder, Meyer, & Hauschildt, 2013). "
    [Show abstract] [Hide abstract]
    ABSTRACT: Social anxiety disorder (SAD) is common, debilitating and associated with high societal costs. The disorder can be effectively treated with Internet-based cognitive behavior therapy (ICBT), but no previous study has investigated the long-term clinical or health economic effects of ICBT for SAD in comparison to an evidence-based control treatment. The aim of the study was to investigate the clinical effectiveness and cost-effectiveness of ICBT compared to cognitive behavioral group therapy (CBGT) four years post-treatment. We conducted a 4-year follow-up study of participants who had received ICBT or CBGT for SAD within the context of a randomized controlled non-inferiority trial. The cost-effectiveness analyses were conducted taking a societal perspective. Participants in both treatment groups made large improvements from baseline to 4-year follow-up on the primary outcome measure (d= 1.34-1.48) and the 95% CI of the mean difference on the primary outcome was well within the non-inferiority margin. ICBT and CBGT were similarly cost-effective and both groups reduced their indirect costs. We conclude that ICBT for SAD yields large sustainable effects and is at least as long-term effective as CBGT. Intervention costs of both treatments are offset by net societal cost reductions in a short time.
    Full-text · Article · Aug 2014 · Behaviour Research and Therapy
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    • "The quality of the eleven studies varied. In five studies [32]; [33]; [38]; [39]; [40] the allocation to conditions was reported adequately, whereas in the other studies it was not [11]; [34]; [35]; [36]; [37]; [41]. Only two studies described concealment of allocation [32]; [33]. "
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    ABSTRACT: A few meta-analyses have examined psychological treatments for a social anxiety disorder (SAD). This is the first meta-analysis that examines the effects of cognitive behavioural group therapies (CBGT) for SAD compared to control on symptoms of anxiety. After a systematic literature search in PubMed, Cochrane, PsychINFO and Embase was conducted; eleven studies were identified that met the inclusion criteria. The studies had to be randomized controlled studies in which individuals with a diagnosed SAD were treated with cognitive-behavioural group therapy (CBGT) and compared with a control group. The overall quality of the studies was moderate. The pooled effect size indicated that the difference between intervention and control conditions was 0.53 (96% CI: 0.33-0.73), in favour of the intervention. This corresponds to a NNT 3.24. Heterogeneity was low to moderately high in all analyses. There was some indication of publication bias. It was found that psychological group-treatments CBGT are more effective than control conditions in patients with SAD. Since heterogeneity between studies was high, more research comparing group psychotherapies for SAD to control is needed.
    Full-text · Article · Dec 2013 · PLoS ONE
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    • "can promote and facilitate the implementation of EST techniques, such as relaxation, or favor the processes of desensitization and extinction in exposure techniques (Barlow et al., 2000; Blanco et al., 2010; Norberg, Krystal, & Tolin, 2008) as well as improving the effectiveness of EST. In contrast, some investigations report that including PT in EST is inappropriate because: (a) combining EST and PT contributes no benefi ts to the use of ESTs (Franklin, "
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    ABSTRACT: Background: The goal of this work is to determine whether the combined use of empirically supported psychological treatments (ESTs) and pharmacological therapy (PT) achieves better results than the isolated use of ESTs in the treatment of Anxiety Disorders (AD) in a welfare clinical setting. Method: A quasi-experimental study was designed, with a sample of 287 patients with primary diagnosis of AD. Of the patients, 25.1% (n = 72) received ESTs+PT and 74.9% (n = 216), only ESTs. At pretreatment, no intergroup differences were observed in anxiety and depressive symptoms, duration of the problem and comorbidity, but there were differences for previous treatments (they were fewer in the EST group). Results: After the intervention, both groups showed similar degree of completion, compliance with treatment, task performance and similar effectiveness at post treatment but EST+PT was significantly longer (16.58 sessions vs. 13.04 sessions). Conclusions: It is concluded that adding PT to EST does not improve the results but it does increase the cost and duration of treatment, thereby reducing the efficiency of the intervention.
    Full-text · Article · Aug 2013 · Psicothema
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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

    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.  

    + 1 more attachment

  • 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
    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.

    https://www.researchgate.net/publication/41656910_A_placebo-controlled_trial_of_phenelzine_cognitive_behavioral_group_therapy_and_their_combination_for_social_anxiety_disorder?ev=prf_pub

    https://www.researchgate.net/publication/227536034_Screening_for_social_anxiety_disorder_with_the_selfreport_version_of_the_Liebowitz_Social_Anxiety_Scale?ev=prf_pub

    https://www.researchgate.net/publication/11057913_Screening_for_social_anxiety_disorder_in_the_clinical_setting_using_the_Liebowitz_Social_Anxiety_Scale?ev=prf_pub

    https://www.researchgate.net/publication/11832833_The_Liebowitz_Social_Anxiety_Scale_a_comparison_of_the_psychometric_properties_of_self-report_and_clinician-administered_formats?ev=prf_pub
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      [Show abstract] [Hide abstract]
      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.
      Full-text · Article · Mar 2010 · Archives of general psychiatry

    + 3 more attachments

  • 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
    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.

    https://www.researchgate.net/publication/41656910_A_placebo-controlled_trial_of_phenelzine_cognitive_behavioral_group_therapy_and_their_combination_for_social_anxiety_disorder?ev=prf_pub

    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.
    • Source
      [Show abstract] [Hide abstract]
      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.
      Full-text · Article · Mar 2010 · Archives of general psychiatry