Sertraline + CBT for Social Anxiety Disorder

Overseen By Amanda Desmarais, MA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Bipolar, Schizophrenia, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if researchers can predict which adults with social anxiety disorder (SAD) will respond well to treatment. Participants will begin with 12 weeks of group cognitive behavioral therapy (CBT), a type of talk therapy. Those who do not improve sufficiently may undergo an additional 12 weeks of individual CBT while taking sertraline, a common medication for anxiety. Individuals with severe social anxiety, particularly in social interactions, might be well-suited for this study. The trial also includes a comparison group of individuals with little or no social anxiety to better understand the differences.

As an unphased trial, this study provides a unique opportunity to contribute to understanding and improving treatments for social anxiety disorder.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sertraline, also known as Zoloft, is approved for treating social anxiety disorder (SAD) and is generally considered safe for this use. However, some individuals might experience side effects such as drowsiness or dizziness, so taking it under a doctor's supervision is important.

Cognitive Behavioral Therapy (CBT) is also a key component of this trial. Studies have found CBT to be highly effective for treating social anxiety. Unlike medications, it typically doesn't cause side effects because it focuses on changing thought patterns rather than using drugs.

Overall, both sertraline and CBT are well-regarded for treating social anxiety, with substantial research supporting their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for social anxiety disorder, which typically include standalone Cognitive Behavioral Therapy (CBT) or medication like sertraline, this approach combines both CBT and sertraline for potentially enhanced effectiveness. Researchers are excited because pairing sertraline, an antidepressant, with group CBT might help address symptoms more thoroughly by targeting both the chemical and behavioral aspects of anxiety. Additionally, this trial includes the use of advanced neuroimaging techniques like EEG and MRI to discover new neuro-markers, which could significantly deepen our understanding of why certain patients respond differently to treatment.

What evidence suggests that this trial's treatments could be effective for social anxiety disorder?

Research has shown that sertraline, one of the treatments in this trial, helps treat social anxiety disorder (SAD). In studies, participants taking sertraline experienced significantly less anxiety than those taking a placebo, which contains no active medicine. Cognitive behavioral therapy (CBT), another treatment option in this trial, also effectively addresses SAD. Group CBT participants demonstrated significant symptom improvements, with some studies showing very strong results. Individual CBT also proves effective, with many participants feeling less anxious even after completing therapy. Both treatments have evidence supporting their ability to help people with SAD feel better and manage their symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Anthony Rosellini, PhD

Principal Investigator

Boston University Charles River Campus

John Gabrieli, PhD

Principal Investigator

Massachusetts Institute of Technology

Daniel Dillon, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Group CBT for Social Anxiety Disorder
• Individual CBT for Social Anxiety Disorder
• Sertraline

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).

How Is the Trial Designed?

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 European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Social Anxiety Disorder
• Anxiety Disorders

Approved in United States as Cognitive Behavioral Therapy for:

• Social Anxiety Disorder
• Anxiety Disorders

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+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Mclean Hospital

Collaborator

Trials

221

Recruited

22,500+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6902232/

Long-term Outcomes of Cognitive Behavioral Therapy for ... Cognitive behavioral therapy was generally associated with lower anxiety symptoms within 12 months after treatment completion.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S088761852400104X

Cognitive behavioral group therapy for social anxiety ... This critical review evaluates the most current research on cognitive behavioral group therapy for social anxiety disorder.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6994736/

A randomized clinical trial of group and individual Cognitive ... The results suggest that both treatments were equally effective in reducing different comorbidity symptoms in patients with SAD, even though the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S088761852200113X

Long-term outcomes of cognitive behavioural therapy for ... Social anxiety outcomes continue to improve 12 months or longer after CBT treatment. •. Moderate gains in general anxiety and depressive symptoms after CBT ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cpp.2799

The effectiveness of cognitive behavioural therapy for ... Results revealed significant reductions in symptoms of SAD between pre- and post-assessments, with effect sizes ranging from d = 0.9 to 1.2.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8475916/

Cognitive-Behavioral Treatments for Anxiety and Stress ... CBT is an effective, gold-standard treatment for anxiety and stress-related disorders. CBT uses specific techniques to target unhelpful thoughts, feelings, and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4244236/

Randomized controlled trial of cognitive behavioral therapy ... This particular CBT has been effective for individuals with social phobia within larger primary care (Craske et al., 2011) and clinic samples (Arch et al., 2012) ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006322301011830

Cognitive-behavioral therapy for social anxiety disorder This article summarizes the data on the efficacy of CBT for the treatment of the symptoms of social anxiety disorder and impaired quality of life. The relative ...

9. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1520581/full

A case report of cognitive behavioral therapy for social ... The case conceptualization approach in social anxiety CBT consultations facilitates patients with social anxiety issues in understanding their problems.

10. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3885-3

A disorder-specific group cognitive behavior therapy for social ... The aim of the present study is to investigate the efficacy of a disorder-specific group cognitive behavior therapy (G-CBT) program for youth SAD.