Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety

NARecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

May 26, 2023

Primary Completion Date

December 1, 2026

Study Completion Date

June 30, 2027

Conditions
Social Anxiety Disorder
Interventions
BEHAVIORAL

Group CBT for Social Anxiety Disorder

Initial CBT will consist of 12 weekly, 2.5-hour group sessions. Later sessions (after session 7) become more individualized as the exposure practices are tailored to the individual participant's concerns. Most often, the exposures are completed outside the group environment. Session content includes various cognitive behavioral strategies tailored to SAD, such as psychoeducation, examining and challenging cognitive distortions, and exposure exercises.

DRUG

Sertraline

Non-responders will initiate sertraline at baseline (week 0) with 25 mg/day followed by a dose increase to 50 mg/day at week 1, 100 mg at week 4, 150 mg at week 6, and 200 mg at week 8. Upward dose titration may be slowed and the dose decreased if necessary due to side effects, but the clinician will attempt to titrate all symptomatic participants up to 200 mg/day if tolerated by week 8, with the last dose increase allowed at week 10. Participants will be assessed at each visit by the study psychiatrist for purposes of dose titration and monitoring. Symptomatic participants unable to reach 200 mg/day of sertraline due to side effects will be maintained in the trial if they are on at least 50 mg/day by week 8; all symptomatic participants will be titrated to their maximally tolerated dose (\< 200 mg/day sertraline). Any participant unable to tolerate sertraline will be discontinued and referred for clinical treatment.

BEHAVIORAL

Individual CBT for Social Anxiety Disorder

Participants who show no or only partial response to the initial group CBT will continue with an individual, tailored form of CBT plus adjunctive SSRI. The format of CBT will include

Trial Locations (1)

02115

RECRUITING

Center for Anxiety and Related Disorders at Boston University, Boston

All Listed Sponsors
collaborator

Massachusetts Institute of Technology

OTHER

collaborator

Mclean Hospital

OTHER

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Boston University Charles River Campus

OTHER