For patients with social anxiety disorder, there appears to be no added
benefit to combining two widely used treatments, new research shows. Unlike
major depression, where combining cognitive-behavioral therapy (CBT) and
pharmacotherapy has been shown to produce a synergistic boosting of patients'
outcomes, patients with social anxiety disorder do just as well whether they
receive an SSRI, a comprehensive form of CBT, or both.
Jonathon R.T. Davidson, M.D., an associate professor of psychiatry at Duke
University Medical Center in Durham, N.C., along with colleagues at the
University of Pennsylvania compared the efficacy of the SSRI fluoxetine alone,
comprehensive CBT (CCBT) alone, placebo pill alone, the combination of CCBT
plus fluoxetine, and CCBT plus placebo in 295 patients. The research, funded
by a grant from the National Institute of Mental Health, was published in the
October Archives of General Psychiatry.
Generalized social anxiety disorder, which the researchers referred to as
generalized social phobia (GSP), has been estimated to affect as much as 14
percent of adults in the United States and begins early in life. It is often
persistent and rarely remits.
Patients were randomly assigned to one of the five treatment groups in the
study, and independent raters were used who were blind to treatment
assignment. Fluoxetine was started at 10 mg a day and increased to 40 mg a day
by day 30 of the 14-week study. If subjects taking fluoxetine were not
significantly improved on 40 mg a day and were tolerating the medication
satisfactorily, the dose could be increased to a maximum of 60 mg a day.
Compliance with fluoxetine/placebo was monitored through pill counts and
The comprehensive form of CBT was a 14-week group treatment that combined"
in vivo exposure" involving role playing, cognitive
restructuring, and social-skills training. Skills training included how to
begin a conversation with a stranger and how to improve certain social
interactive skills, like maintaining eye contact. Sessions were held once a
week and included both men and women therapists. The first two sessions were
educational in nature, with later sessions advancing in difficulty with
increased interaction between patients and therapists and between patients
All patients were independently rated at four, eight, and 14 weeks using
the Clinical Global Impression—Improvement scale (CGI-I), the Clinical
Global Impression—Severity scale (CGI-S), and the Brief Social Phobia
Scale (BSPS) as the primary outcomes for the study. In addition, the Social
Phobia and Anxiety Inventory was used as a secondary measure.
By week 14, 54.2 percent of those receiving both fluoxetine and CCBT
reported "very much improvement" (CGI-I score of 1) or "much
improvement" (CGI-I score of 2) in their social phobia. In the group
taking only fluoxetine, 50.9 percent reported a CGI-I of 1 or 2. Of those
patients assigned to receive only CCBT, 51.7 percent achieved a CGI-I of 1 or
2. Of those receiving the CCBT/placebo combination, 50.8 percent achieved a
CGI-I of 1 or 2. Lastly, of those assigned to receive only placebo, 31.7
percent achieved a CGI-I of 1 or 2.
"All active treatments were superior to placebo on primary
outcomes," Davidson and his coauthors wrote. "Combined treatment
did not yield further advantage. Notwithstanding the benefits of treatment,
many patients remained symptomatic after 14 weeks."
However, fluoxetine was found to generate a faster response than the
comparison treatments. By week 4, fluoxetine showed superiority to
CCBT/fluoxetine together, CCBT/placebo together, and placebo alone. By week 14
the degree of improvement did not significantly differ between CCBT and
"Such a finding suggests that greater advantage would accrue from a
strategy of initial treatment with an SSRI, followed by augmentation with
psychosocial treatment after four to eight weeks," the authors observed,
noting they are planning to study such a treatment scheme for GSP.
Significantly higher rates of specific treatment-emergent events were noted
on a few symptoms. Both insomnia and headache were more common in the placebo
and CCBT/placebo groups compared with the CCBT group and in the
CCBT/fluoxetine and fluoxetine groups compared with CCBT alone. This"
indicates that pill taking itself (whether drug or placebo) is
associated with a high rate of headaches and insomnia," the authors
Similarly, nausea occurred more often in the placebo and CCBT/placebo
groups relative to the CCBT alone group, and in the fluoxetine group, relative
to the CCBT group.
Davidson and his coauthors wondered "whether longer-term
pharmacologic treatment is necessary and if changes in the delivery of CCBT
would improve results."
An abstract of "Fluoxetine, Comprehensive Cognitive Behavioral
Therapy, and Placebo in Generalized Social Phobia" is posted online at<http://archpsyc.ama-assn.org/cgi/content/abstract/61/10/1005>.▪
Arch Gen Psychiatry2004611005