Actively Recruiting
Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
Led by Boston University Charles River Campus · Updated on 2025-02-19
240
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
B
Boston University Charles River Campus
Lead Sponsor
M
Massachusetts Institute of Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender or race between 18-50 years old.
- For healthy controls: Liebowitz Social Anxiety Scale score 30 or less and no current Axis I psychiatric condition.
- For social anxiety disorder group: primary complaint of social anxiety with social interaction fear and Liebowitz Social Anxiety Scale score 60 or higher.
- Clinical severity of at least mild (Clinical Global Impressions Scale score 3 or more).
- Medical history and lab results without significant abnormalities.
- Willingness and ability to give informed consent and follow the study protocol.
You will not qualify if you...
- Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder.
- Eating disorder in past 6 months.
- Organic brain syndrome, intellectual disability, or cognitive dysfunction interfering with therapy.
- Substance or alcohol abuse or dependence (except nicotine) in last 6 months.
- Significant suicidal thoughts or behaviors within 6 months before intake.
- Concurrent psychotropic medication dose not stabilized for at least 2 weeks prior to treatment.
- Significant personality dysfunction interfering with participation.
- Serious medical illness or instability that may require hospitalization or affect brain imaging, unless in remission for 12 months.
- Current or past seizures.
- Pregnancy, lactation, or potential for pregnancy.
- Psychotherapy started within 3 months before baseline or ongoing psychotherapy directed at social anxiety.
- Prior non-response to adequate exposure treatment.
- History of head trauma causing loss of consciousness, seizures, or cognitive impairment.
- Contraindications for MRI such as metal implants, surgical clips, braces, or claustrophobia.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
A
Anthony J Rosellini, PhD
CONTACT
A
Amanda Desmarais, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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