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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Apr 1, 2027 → Jun 30, 2027
See other at-risk trials from Boston University Charles River Campus

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 1, 2027 to Jun 30, 2027v10
  2. Primary completion date: Dec 1, 2026 to Apr 1, 2027v9
  3. Eligibility criteria expanded, about 43 words
    • Site contact updated
    v8
  4. Primary completion date: Dec 31, 2026 to Dec 1, 2026v7
  5. Primary completion date: Sep 30, 2026 to Dec 31, 2026
    • Start date: Jun 1, 2023 to May 26, 2023
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary endpoints: 4 to 2
    • Secondary endpoints: 6 to 8
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 8 more changesShow less
    • Start date: Apr 2023 to Jun 1, 2023
    • Primary endpoints revised (4)
    • Enrollment target: 290 to 240
    • Study sites: 0 to 1
    • Primary completion date: Sep 2026 to Sep 30, 2026
    • Study completion date: Jun 2027 to Jun 30, 2027
    • Secondary endpoints revised (6)
    • Study description revised
  4. Study description shortened, about 5 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05683223
Lead Sponsor Boston University Charles River Campus
Collaborators: Massachusetts Institute of Technology, Mclean Hospital, National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Social Anxiety Disorder
Related terms Phobia, Social
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov