CBT for Social Anxiety

Cognitive Behavioral Therapy for Social Anxiety Disorder

0Study Title: Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder

Sponsor: National Institute of Mental Health

Objective: This study aims to evaluate whether d-cycloserine (DCS) can enhance the effectiveness of cognitive-behavioral therapy (CBT) in improving treatment outcomes for social anxiety disorder. In addition, the current study seeks to determine whether the timing of the DCS dosage is important for memory consolidation. D-cycloserine targets receptors in the brain that are involved in learning and memory. Thus, d-cycloserine is not an antidepressant or anxiolytic medication, but rather an agent that aims to improve the memory of the learning that takes place during psychotherapy session. Eligible participants will receive 5 weeks of group cognitive behavioral therapy (CBT), which will target the symptoms of social phobia. The intervention emphasizes repeated exposure tasks, consisting of role-play activities within a group setting to elicit fearful social situations. Continued practice of the intervention is included in the treatment protocol in the form of home-practice strategies. In addition, participants will be randomly assigned to one of four conditions detailing DCS administration. Each participant will be asked to take two study pills (i.e. 1 pill before session/1 pill immediately following session) at four separate sessions in the protocol (sessions 2-5). Participants will be randomly assigned to: 1) receive four 50-mg doses of DCS before the session/four doses of pill placebo after the session 2) receive four doses of pill placebo before session/ four 50-mg doses of DCS after the session 3) four doses of pill placebo before the session/four doses of pill placebo after the session 4) four does of pill placebo before the session/four doses of 50mg DCS or pill placebo after the session. The primary outcome measure is the improvement in social phobia symptoms, which will be assessed at three separate visits following the last session (1 week post-treatment, 1 month follow-up, 3 month follow-up). The patient’s participation will help investigators determine whether or not administering a dose of d-cycloserine before a therapy session will help the patient to retain the new behaviors learned in session and therefore, reduce symptoms associated with social anxiety disorder.

Clinical Trials Registryhttp://clinicaltrials.gov/ct2/show/NCT02066792?term=dcs+social+phobia&rank=1

Status: This study is currently recruiting participants.

IRB Protocol: 2013-11-0070

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