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12 week randomised, placebo controlled trial.
2 clinical centres for anxiety disorders in New York, USA.
133 patients who were 19–61 years of age (mean age 35 y, 50% women), met DSM-III-R criteria for social phobia, were fluent in English, and were able to give consent and participate responsibly in treatment. Exclusion criteria included schizophrenia, major depression, prominent risk of self harm, organic mental disorder, history of bipolar I disorder, substance abuse in the previous 6 months, previous adequate trial of cognitive behavioural therapy or monoamine oxidase inhibitors for social phobia, and serious medical condition. Follow up was 80%.
After stratification by social phobia subtype, patients were allocated to phenelzine sulfate, 15 mg/tablet (n=31); matching placebo (n=33); CBGT (n=36); or educational and supportive group therapy (attention placebo procedure, n=33). Phenelzine doses were started at 15 mg/day and increased to 30 mg/day on day 4, to 45 mg/day on day 8, and to 60 mg/day on day 15. Doses could be raised to 75 mg/day after 4 weeks and to 90 mg/day after 5 weeks. CBGT consisted of 12 sessions of 2.5 hours with 5–7 patients in each group; patients were encouraged to identify and counteract negative thoughts, to confront fearful situations, and to meet behavioural goals. The attention placebo procedure included supportive group therapy and presentation and discussion of topics relevant to social phobia.
Main outcome measures
Response was assessed by the Social Phobic Disorders Severity and Change Form (score of 1 or 2).
Analysis was by intention to treat. At 12 weeks, responder rates were 58% for CBGT, 65% for phenelzine, 33% for placebo, and 27% for the attention placebo procedure. The CBGT and phenelzine groups had more responders than did the respective placebo groups (p<0.005); CBGT and phenelzine did not differ for responder rate (table⇓).
In patients with social phobia, cognitive behavioural group therapy and phenelzine were both effective.
An attractive feature of this well designed clinical trial was the testing of “allegiance effects” by conducting the study at 2 sites, each associated primarily with publishing outcome studies of either psychosocial or pharmacological treatments. Apart from the competent appraisal of treatment effects themselves, the authors examined whether disparate outcomes were associated with the 2 service settings. Fortunately, allegiance effects seemed non-existent; CBGT and phenelzine were equivalently effective regardless of site. The use of credible placebo control groups for CBGT and phenelzine (educational supportive therapy and pill placebo, respectively) enhances the validity of the conclusion that the 2 primary therapies being tested were genuinely effective in alleviating social phobia.
In addition to the standard outcome reportage of inferential statistics, the authors are to be commended for including the magnitude of effect size estimates for selected outcome measures.1 Another useful outcome measure not included in the present study would be the numbers of patients in each treatment group who no longer meet the DSM criteria for social phobia at the conclusion of treatment, which is truly the acid test of any therapy.
Both phenelzine and CBGT are apparently effective in the short term (after 12 weeks of treatment). What will be of equal interest is what happens to patients at long term follow up once the active therapies are stopped. Are the coping skills and other behavioural competencies acquired during CBGT maintained and generalised once group therapy is concluded? When phenelzine is withdrawn, what happens to phobic anxiety? For some of the anxiety disorders (eg, panic disorder, obsessive compulsive disorder), selected psychotropic medications are a good treatment but a bad cure, with high relapse rates occurring once the drugs are stopped. The same disorders treated behaviourally show slower initial improvements but more durable positive effects once treatment is stopped. Will the same pattern emerge for social phobia, or will phenelzine's ameliorative effects prove curative? The authors promise further reports of longer duration treatments with these therapies, as well as evaluations of their combined use. In the interim, on the basis of this and related clinical trials, practising clinicians should consider either CBGT or phenelzine as best practices in caring for patients with social phobia.
Sources of funding: National Institute of Mental Health; New York State Psychiatric Institute Mental Health Clinic Research Center; drugs supplied by Parke-Davis Pharmaceuticals.
For correspondence: Dr R G Heimberg, Adult Anxiety Clinic of Temple, Department of Psychology, Temple University, Weiss Hall, 1701 N 13th Street, Philadelphia, PA 19122–6085, USA. Fax +1 215 204 2155.
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