Predicting treatment outcomes in social anxiety disorder

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

This study is trying to see if brain scans can help predict which adults with social anxiety disorder will benefit from group therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Boston University Charles River Campus (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05683223 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine if neural markers can predict which adults with social anxiety disorder (SAD) will respond to treatment. The study will recruit 190 adults with SAD to undergo brain imaging before and after 12 weeks of group cognitive behavioral therapy (CBT). Those who do not respond adequately will have the option to continue with individual CBT and sertraline for an additional 12 weeks. A control group of 50 participants with minimal social anxiety will also be included for comparison. The research will utilize EEG and MRI to identify neural mechanisms associated with treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-50 with a primary diagnosis of social anxiety disorder and significant distress related to social interactions.

Not a fit: Patients with mild social anxiety or those without a primary psychiatric condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment strategies for individuals with social anxiety disorder.

How similar studies have performed: Other studies have shown promise in using neural markers to predict treatment outcomes, but this specific approach is relatively novel.

Eligibility criteria

Inclusion criteria for all participants:

(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:

1. 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.
2. Overall clinical severity of at least mild as defined by Clinical Global Impressions Scale (CGI-S; Zaider et al., 2003) of at least 3.
3. Medical history interview and laboratory findings without clinically significant abnormalities.
4. Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.

Exclusion criteria:

1. 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.
2. . 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.
3. 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.
4. Significant personality dysfunction likely to interfere with study participation.
5. 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.
6. Patients with a current or past history of seizures.
7. Pregnant women, lactating women, and women of childbearing potential who may become pregnant.
8. 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.
9. 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).
10. Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
11. Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, braces, or claustrophobia.

Where this trial is running

Boston, Massachusetts

• Center for Anxiety and Related Disorders at Boston University — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: John Gabrieli, PhD — Massachusetts Institute of Technology
• Study coordinator: Anthony J Rosellini, PhD

Conditions Social Anxiety Disorder; social anxiety disorder; sertraline; exposure therapy; social cost; MRI; EEG; structural connectivity