BOSTON -- Cognitive-behavioral therapy was shown superior to self-exposure instructions combined with fluoxetine or placebo for treating social phobia, Dr. David M. Clark said at the annual meeting of the Association for Advancement of Behavioral Therapy.
These findings are based on a randomized trial involving 123 patients who were referred to the study by general primary care physicians, psychiatrists, and psychologists. On the basis of assessments using a combination of the Anxiety Disorders Interview Schedule for DSM-IV (ADIS) and the Structured Clinical Interview for DSM-IV Axis-1 Disorders, 60 patients met the study entry criteria.
Eligible patients were randomized to one of three treatment groups--20 patients each to cognitive behavioral therapy (CBT), self-exposure plus fluoxetine, and self-exposure plus placebo.
The CBT component was based on a social phobia maintenance model developed by Dr. Clark and his colleagues in 1995 that uses a variety of procedures to reverse maintaining social phobic factors. The treatment steps included developing a personal maintenance model based on patients' own thoughts, symptoms, and behaviors; experiential exercises involving key safety behaviors and self-focused attention; shifting focus of attention to the social situation; video feedback to modify distorted self-imagery; behavioral experiments; identifying problematic anticipatory and postevent processing; and modifying dysfunctional assumptions.
In the fluoxetine arm, a maximum 60-mg dosage of the medication was combined with weekly self-exposure assignments, with the intention of producing a close approximation to routine clinical practice. The third study arm combined placebo with weekly self-exposure assignments. "We included the placebo arm as a way to estimate the extent to which improvements associated with fluoxetine plus self-exposure were active pharmacologic effects," said Dr. Clark of the Institute of Psychiatry in London.
In all three groups, patients had up to 16 weekly treatment sessions. After 16 weeks, the medication blind was broken. Patients who had been randomized to the fluoxetine arm continued their medication for 3 months and had up to three treatment sessions during this "booster" period.
Patients who were allocated to placebo were withdrawn from the trial and offered their choice of CBT, fluoxetine and self-exposure, or a combination of both. Patients in the CBT group also had up to three treatment sessions during the 3-month booster period, according to Dr. Clark.
All of the patients were evaluated by independent assessors pretreatment, midtreatment, post treatment, during the booster period, and at 12-month follow-up. …