What side effects are associated with this type of intervention?

Group Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder (SAD) is generally well-tolerated with minimal side effects. Some individuals may experience temporary increases in anxiety or emotional discomfort as they confront feared situations or thoughts during therapy sessions. Other potential side effects include stress, frustration, or fatigue from the effort required to engage in therapy. However, these effects are typically short-lived and diminish as treatment progresses. Overall, CBT is considered a safe and effective treatment for SAD with a favorable side effect profile compared to pharmacological interventions.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Social Anxiety Disorder (SAD), including selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine, and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine. Benzodiazepines, like clonazepam, are also used but are generally considered when there is no history of substance use disorder due to their potential for dependence. Cognitive Behavioral Therapy (CBT) is a well-established psychological intervention for SAD, focusing on changing patterns of thinking and behavior to reduce anxiety. Group CBT, as studied in clinical trials, is an effective non-pharmacological treatment option for SAD.

What other types of research exist?

Promising novel alternatives to Group CBT for Social Anxiety Disorder include: 1) Virtual Reality Exposure Therapy (VRET), which uses immersive virtual environments to safely expose patients to social situations, 2) Acceptance and Commitment Therapy (ACT), which focuses on accepting anxiety and committing to personal values, and 3) Mindfulness-Based Stress Reduction (MBSR), which incorporates mindfulness meditation to reduce anxiety and improve emotional regulation. These alternatives have shown efficacy in clinical trials and offer different therapeutic approaches compared to traditional CBT.

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Sertraline + CBT for Social Anxiety Disorder

N/A

Recruiting

Led By John Gabrieli, PhD

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 12 weeks, 19 and 25 weeks for non-responders

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Sertraline might cause nausea, sleep issues, tremors or dizziness. CBT generally has no side effects but could temporarily increase anxiety levels as patients confront their fears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 12 weeks, 19 and 25 weeks for non-responders

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 12 weeks, 19 and 25 weeks for non-responders

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks, 19 and 25 weeks for non-responders for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Clinical Global Impression-Improvement Scale (CGI-I)

Change in Liebowitz Social Anxiety Scale (LSAS)

Secondary study objectives

Change in Clinical Global Impression Severity scale (CGI-S)

Changes in the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

General Anxiety Disorder-7 (GAD-7)

+5 more

Other study objectives

Credibility/Expectancy Questionnaire (CEQ)

Kaufman Brief Intelligence Test (KBIT)

Social Cost Questionnaire (SCQ)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: RespondersExperimental Treatment1 Intervention

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

Group II: Non-RespondersExperimental Treatment3 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: ControlsActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sertraline

2002

Completed Phase 4

~5470

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Social Anxiety Disorder (SAD) include Cognitive Behavioral Therapy (CBT) and medications such as SSRIs. CBT works by helping patients identify and change negative thought patterns and behaviors that contribute to their anxiety, thereby reducing symptoms and improving social functioning. This is achieved through techniques like exposure therapy, where patients gradually face social situations they fear, and cognitive restructuring, which helps them challenge and modify irrational beliefs. SSRIs, on the other hand, increase serotonin levels in the brain, which can help improve mood and reduce anxiety. These treatments are crucial for SAD patients as they address both the psychological and physiological aspects of anxiety, leading to more comprehensive and effective management of the disorder.