Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
Key facts
- Who runs it
- Boston University Charles River Campus
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 240 people, planned
- Started
- 26 May 2023
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Group CBT for Social Anxiety Disorder
- Sertraline
- Individual CBT for Social Anxiety Disorder
- Record updated
- 23 July 2026
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- (1) Any gender or race between 18-50 years old
- Additional inclusion criteria for healthy controls:
- (1) Liebowitz Social Anxiety Scale (LSAS; Mennin et al., 2002) score <= 30, does not currently meet criteria for an Axis I psychiatric condition, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5; American Psychiatric Association, 2013)
- Additional inclusion criteria for the social anxiety disorder (SAD) group:
- Outpatients with a primary psychiatric complaint (designated by the patient as the most important source of current distress) of social anxiety with social interaction fear as defined by an Liebowitz Social Anxiety Scale (LSAS) score >= 60
- Overall clinical severity of at least mild as defined by Clinical Global Impressions Scale (CGI-S; Zaider et al., 2003) of at least 3
- Medical history interview and laboratory findings without clinically significant abnormalities
- Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol
Who cannot take part
- . Patients with significant suicidal ideation Montgomery-Åsberg Depression Rating Scale (10 items, self-report) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention
- Patients can be taking a concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers, sertraline), but the dose must be stabilized for at least 2 weeks prior to initiation of randomized treatment
- Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the social anxiety is excluded. Individuals with prior CBT experience or treatments that included cognitive and behavioral skills and exposure procedures (e.g., assertiveness and social skills trainings) will be excluded. General supportive or insight-oriented therapy initiated > 3 months prior is acceptable
- Prior non-response to adequately-delivered exposure (i.e., as defined by the patient's report of receiving specific and regular exposure assignments as part of a previous treatment)
- Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, braces, or claustrophobia
- A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, intellectual disability, or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol, marijuana, and stimulant use during the acute period of study participation
- Serious medical illness, associated treatment, or other instability for which hospitalization may be likely within the next year, or which may alter fMRI or EEG measurements. Participants with a history of serious medical illness or treatments that may alter fMRI measurements may enroll in the study 12 months after the condition has been remitted and ending treatment
- Patients with a current or past history of seizures
- Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment
- Significant personality dysfunction likely to interfere with study participation
- Pregnant women, lactating women, and women of childbearing potential who may become pregnant
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Where in United States
- Center for Anxiety and Related Disorders at Boston UniversityBoston, United StatesContact: Anthony Rosellini, PhDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- RespondersTreatment being tested
The experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder.
Treatment: Group CBT for Social Anxiety Disorder
- Non-RespondersTreatment being tested
The experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder. Non-responders to initial exposure therapy will receive sertraline and additional exposure therapy prior to final EEG and MRI.
Treatment: Group CBT for Social Anxiety Disorder, Sertraline, and Individual CBT for Social Anxiety Disorder
- ControlsNo study treatment, for comparison
Controls will receive baseline EEG and MRI, screening questionnaires and intake interview. They will not participate in therapy but complete weekly symptom measures and a second EEG/MRI session 12 weeks after baseline. Control participants will be compared with social anxiety participants to determine differences in neuro-markers at baseline and over follow-up.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT05683223, who can take part
- Record updated
- 23 July 2026