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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

Show all 19 criteriaShow less

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT05683223, who can take part
Record updated
23 July 2026