Sertraline + CBT for Social Anxiety Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Anthony Rosellini, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston University Charles River Campus

Disqualifiers: Bipolar, Schizophrenia, Substance abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to predict which adults with severe social anxiety will respond to group therapy. If group therapy doesn't work, participants will try one-on-one therapy and a common anxiety medication. The goal is to understand how different treatments affect the brain and improve anxiety.

Will I have to stop taking my current medications?

You can continue taking your current psychotropic medications (like antidepressants or anxiolytics), but the dose must be stable for at least 2 weeks before starting the trial.

What data supports the effectiveness of the drug sertraline combined with CBT for treating social anxiety disorder?

Research shows that sertraline, when used with therapy, can improve social skills in people with social anxiety disorder. In one study, 80% of patients taking sertraline showed significant improvement in social anxiety symptoms. ^{1 2 3 4 5}

Is the combination of Sertraline and CBT safe for treating social anxiety disorder?

Research shows that Sertraline, a medication often used for anxiety, is generally well-tolerated in humans. Studies involving Sertraline for social anxiety disorder have focused on its effectiveness and tolerability, indicating it is safe for use in adults. ^{1 2 3 4 6}

How does the treatment of sertraline combined with CBT differ from other treatments for social anxiety disorder?

The combination of sertraline (a medication that helps balance chemicals in the brain) and cognitive behavioral therapy (CBT, a type of talk therapy) is unique because it addresses both the chemical and behavioral aspects of social anxiety disorder, potentially offering more comprehensive improvement than either treatment alone. ^{1 2 3 4 6}

Research Team

John Gabrieli, PhD

Principal Investigator

Massachusetts Institute of Technology

Daniel Dillon, PhD

Principal Investigator

Mclean Hospital

Anthony Rosellini, PhD

Principal Investigator

Boston University Charles River Campus

Eligibility Criteria

Adults aged 18-50 with severe social anxiety can join this trial. Exclusions include those with bipolar, schizophrenia, recent substance abuse, significant suicidal thoughts or actions, unstable serious medical conditions, pregnancy, and certain metal implants that interfere with MRI scans.

Inclusion Criteria

I have social anxiety with a fear of social interaction, and my tests show it's at least mild.

I am between 18 and 50 years old.

Additional inclusion criteria for healthy controls: Liebowitz Social Anxiety Scale (LSAS) score <= 30, does not currently meet criteria for an Axis I psychiatric condition as defined by DSM-5

Exclusion Criteria

Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, obsessive-compulsive disorder, eating disorder in the past 6 months, organic brain syndrome, intellectual disability, cognitive dysfunction that could interfere with capacity to engage in therapy, history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months, significant suicidal ideation, suicidal behaviors within 6 months prior to intake, significant personality dysfunction likely to interfere with study participation, serious medical illness or instability for which hospitalization may be likely within the next year, current or past history of seizures, pregnant women, lactating women, women of childbearing potential who may become pregnant, concurrent psychotherapy initiated within 3 months of baseline, ongoing psychotherapy directed specifically toward treatment of social anxiety, prior non-response to adequately-delivered exposure, history of head trauma causing loss of consciousness, seizure, ongoing cognitive impairment, contraindications for MRI

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

EEG and MRI assessments are conducted to establish baseline neural markers

1 week

1 visit (in-person)

Group CBT Treatment

Participants with SAD undergo 12 weeks of group cognitive behavioral therapy

12 weeks

Weekly sessions (in-person)

Individual CBT and SSRI Treatment

Non-responders to group CBT receive additional 12 weeks of individual CBT with sertraline

12 weeks

Weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

Periodic assessments (in-person)

Treatment Details

Interventions

• Group CBT for Social Anxiety Disorder (Behavioral)
• Individual CBT for Social Anxiety Disorder (Behavioral)
• Sertraline (SSRI)

Trial Overview The study is testing if brain imaging before and after group CBT can predict treatment success in social anxiety disorder. Non-responders to group therapy may receive individual CBT plus sertraline (an SSRI medication).

Participant Groups

Group I: Responders Experimental Treatment 1 Intervention

The experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder.

Group II: Non-Responders Experimental Treatment 3 Interventions

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.

Group III: Controls Active Control 1 Intervention

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.

Group CBT for Social Anxiety Disorder is already approved in Canada for the following indications:

Approved in Canada as Cognitive Behavioral Therapy for:

• Social Anxiety Disorder
• Anxiety Disorders

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

Dr. Melissa Gilliam

Boston University Charles River Campus

Chief Executive Officer

MD from Yale School of Medicine

Dr. Alastair Bell

Boston University Charles River Campus

Chief Medical Officer since 2023

MD from Harvard Medical School

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Sally Kornbluth

Massachusetts Institute of Technology

Chief Executive Officer since 2023

PhD in Molecular Biology from Rockefeller University

Angela Koehler

Massachusetts Institute of Technology

Chief Medical Officer

MD from Harvard Medical School

Mclean Hospital

Collaborator

Trials

221

Recruited

22,500+

Dr. Susan M. Szulewski

Mclean Hospital

Chief Medical Officer since 2023

MD from University of Medical Sciences in Poznan, Poland; MBA from Heller School at Brandeis University

Dr. Scott L. Rauch

Mclean Hospital

Chief Executive Officer since 2006

MD from Harvard Medical School

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

Sertraline (SER) combined with psychotherapy showed significantly better improvement in social anxiety symptoms compared to psychotherapy alone, with a response rate of 25.73% for SER versus 9.46% for placebo.

While group cognitive-behavioral therapy (GCBT) and group psychodynamic therapy (GPT) did not show significant differences in efficacy, SER combined with GPT was superior to placebo combined with GPT, indicating that SER enhances the effectiveness of psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant treatment with sertraline and social skills training improves social skills acquisition in social anxiety disorder: A double-blind, randomized controlled trial. Bernik, M., Corregiari, F., Savoia, MG., et al.[2022]

In a 12-week open trial of sertraline involving 22 patients with Social Phobia, 80% of participants responded positively to the treatment after at least 8 weeks.

Statistically significant improvements were observed in social anxiety, avoidance, depression, and social functioning from the beginning to the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sertraline in social phobia. Van Ameringen, M., Mancini, C., Streiner, D.[2019]

In a study involving 211 adults with severe generalized social anxiety disorder, sertraline significantly reduced anxiety symptoms compared to placebo, as measured by the Liebowitz Social Anxiety Scale, with a mean score change of -31.0 for sertraline versus -21.7 for placebo.

Sertraline was well tolerated, with only 7.6% of patients discontinuing due to side effects, indicating it is a safe option for treating this chronic condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of sertraline in severe generalized social anxiety disorder: results of a double-blind, placebo-controlled study. Liebowitz, MR., DeMartinis, NA., Weihs, K., et al.[2022]

In a study involving 619 participants with generalized social anxiety disorder (SAD), treatment with sertraline significantly improved symptoms across all dimensions of the Brief Social Phobia Scale, including fear, avoidance, and physiological arousal.

Specifically, sertraline was particularly effective in reducing physiological symptoms like blushing and palpitations, while its effects on trembling and sweating were less pronounced, highlighting the varied responsiveness of different symptoms to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidimensional effects of sertraline in social anxiety disorder. Connor, KM., Davidson, JR., Chung, H., et al.[2022]

In a double-blind crossover study involving 12 outpatients, sertraline (50-200 mg/day) significantly improved social anxiety symptoms compared to placebo, as measured by the Liebowitz Social Anxiety Scale.

The study suggests that sertraline is a safe and effective treatment for social phobia, and that patients may prefer computer-administered assessments over clinician interviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sertraline for social phobia: a double-blind, placebo-controlled crossover study. Katzelnick, DJ., Kobak, KA., Greist, JH., et al.[2022]

In a study of 50 adults with generalized social phobia, sertraline significantly reduced the risk of relapse compared to switching to a placebo, with only 4% of those continuing sertraline relapsing versus 36% in the placebo group.

The study demonstrated that sertraline not only helped maintain improvements in social phobia symptoms but also had a higher treatment completion rate (88% vs. 40%) compared to the placebo-switch group, indicating its efficacy and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of relapse in generalized social phobia: results of a 24-week study in responders to 20 weeks of sertraline treatment. Walker, JR., Van Ameringen, MA., Swinson, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Concomitant treatment with sertraline and social skills training improves social skills acquisition in social anxiety disorder: A double-blind, randomized controlled trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Sertraline in social phobia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of sertraline in severe generalized social anxiety disorder: results of a double-blind, placebo-controlled study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Multidimensional effects of sertraline in social anxiety disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sertraline for social phobia: a double-blind, placebo-controlled crossover study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Prevention of relapse in generalized social phobia: results of a 24-week study in responders to 20 weeks of sertraline treatment. [2022]