RecruitingNot ApplicableNCT05683223

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

Sponsor

Boston University Charles River Campus

Enrollment

240 participants

Start Date

May 26, 2023

Study Type

INTERVENTIONAL

Conditions

Social Anxiety Disorder

Summary

The purpose of this clinical trial is to answer the question: can the investigators predict which adults with social anxiety disorder (SAD) will successfully respond to treatment? To answer this question, the investigators plan to recruit 190 adult participants who experience extreme forms of social anxiety to undergo brain imaging before and after 12 weeks of group cognitive behavioral therapy (CBT). Adults in the SAD group who do not respond enough to group CBT may be offered the opportunity to complete an additional 12 weeks of individual CBT while receiving SSRI medication (sertraline, see below) for SAD. Data collected from participants who experience anxiety will be compared to a group of 50 participants with little or no social anxiety, who will serve as a comparison group.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at brain activity patterns in people with social anxiety disorder to better understand why certain treatments work — and to predict who is most likely to benefit from treatment before they even start. **You may be eligible if...** - You are between 18 and 50 years old - You are either a healthy person with low social anxiety (for the control group), OR - You have been diagnosed with social anxiety disorder as your primary concern, with significant fear in social situations and a high score on a standard social anxiety scale - You are willing to undergo brain imaging and complete study tasks **You may NOT be eligible if...** - You have a history of bipolar disorder, schizophrenia, or psychosis - You have had an eating disorder in the past 6 months - You have a history of substance or alcohol abuse - You have intellectual disability or significant cognitive impairment - You have other conditions that would interfere with the study tasks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALGroup 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.

DRUGSertraline

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.

BEHAVIORALIndividual 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