Phobic Disorders Clinical Trial
Official title:
A Randomised, Triple Blind, Placebo-controlled Trial Comparing the Effects of Cognitive Therapy, Paroxetine and Both Cognitive Therapy and Paroxetine in the Treatment of Patients With Primary Social Phobia
We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their
combination, (2) investigate the patterns of change and the mechanisms of action involved
during treatment by using psycho-physiological assessments in order to delineate some of the
cognitive, behavioural and physiological mechanisms in the patients' response to CT, to
paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be
selected and randomised into four treatment conditions. The first group (N=25) will be
treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group
(N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo
and clinical management (N=25). All patients will have 12 weeks of treatment in the acute
phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd
and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The
4th group will have placebo for 24 weeks and clinical management. The patients will be
assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12
weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months.
Measures are based on all three main sources; self-report inventories, clinical assessments
by independent raters and psycho-physiological assessments.
n/a
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