Cognitive Behavioral Therapy for Social Anxiety Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Daniel F Gros, PhD MA BS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic symptoms, Personality disorder, Substance use, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Cognitive behavioral therapy (CBT) is a brief, efficient, and effective treatment for individuals with depressive/anxiety disorders. However, CBT is largely underutilized within the Department of Veterans Affairs due to the cost and burden of trainings necessary to deliver all of the related disorder-specific treatments (DSTs). Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol in Veterans with depressive/anxiety disorders. The proposed research seeks to evaluate the efficacy of TBT by assessing psychiatric symptomatology and related impairment outcomes in Veterans with social anxiety disorder and comorbid posttraumatic stress via a randomized controlled trial of TBT and an existing DST. Assessments will be completed at pre-, mid-, and post-treatment, and at 6-month follow-up. Process variables also will be investigated.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have recently started new psychiatric medications within the last 4 weeks, you may not be eligible to participate.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Social Anxiety Disorder?

Research shows that Cognitive Behavioral Therapy (CBT) is highly effective for treating social anxiety disorder, with significant reductions in symptoms observed in various studies. Both individual and group CBT approaches have been shown to reduce social anxiety and related symptoms, and these improvements are often maintained over time. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for treating social anxiety disorder?

Cognitive Behavioral Therapy (CBT), including its transdiagnostic forms, has been widely studied and is generally considered safe for treating social anxiety disorder and other anxiety-related conditions. Clinical trials and studies have shown that it can effectively reduce symptoms without significant safety concerns. ^{3 6 7 8 9}

How is Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder different from other treatments?

Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder is unique because it can be delivered in both disorder-specific and transdiagnostic formats, which means it can address multiple anxiety and emotional disorders simultaneously. This flexibility allows it to be effective for people with social anxiety and other co-occurring conditions, offering a comprehensive approach compared to treatments that focus on a single disorder. ^{3 5 8 10 11}

Research Team

Daniel F Gros, PhD MA BS

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Eligibility Criteria

This trial is for Veterans registered at Ralph H. Johnson VA Health Care System who have been diagnosed with social anxiety disorder and also show symptoms of posttraumatic stress. They must be able to give informed consent. Specific details on who can't join are not provided.

Inclusion Criteria

Participants must be Veterans and registered at Ralph H. Johnson Veterans Affairs Health Care System

Participants must meet DSM-5 criteria for social anxiety disorder

I understand and can consent to participate in research.

Exclusion Criteria

Primary diagnosis of a condition associated with psychotic symptoms, personality disorder, substance use disorder, or bipolar disorder.

Acute, severe illness or medical condition that likely will interfere with study procedures as documented in their medical record

I started new psychiatric medication less than 4 weeks ago.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive either Transdiagnostic Behavior Therapy (TBT) or Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder over 12 weekly sessions

12 weeks

12 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month follow-up

6 months

1 visit (in-person or virtual)

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Social Anxiety Disorder (Behavioral Intervention)
• Transdiagnostic Behavior Therapy (Behavioral Intervention)

Trial Overview The study compares Transdiagnostic Behavior Therapy (TBT), a versatile treatment for various disorders, with Cognitive Behavioral Therapy (CBT) specifically designed for Social Anxiety Disorder in treating veterans with both conditions.

Participant Groups

Group I: Transdiagnostic Behavior Therapy Experimental Treatment 1 Intervention

TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.

Group II: Cognitive Behavioral Therapy for Social Anxiety Disorder Active Control 1 Intervention

To provide an evidence-based comparison for the TBT condition, the research-supported psychological treatment of CBT for SAD will be used. CBT for SAD demonstrates efficacy in improving SAD symptoms and quality of life for patients with SAD, with durable improvements evidenced at follow-up assessments. CBT for SAD was used as a comparison to TBT in previous preliminary research. CBT for SAD involves several primary components, including: 1) psychoeducation, 2) training in cognitive restructuring, 3) exposures, 4) advanced cognitive restructuring, and 5) termination.

Cognitive Behavioral Therapy for Social Anxiety Disorder is already approved in Canada for the following indications:

Approved in Canada as Cognitive Behavioral Therapy for:

• Social Anxiety Disorder
• Depressive Disorders
• Anxiety Disorders
• Posttraumatic Stress Disorder

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

This pilot study will be the first to directly compare the efficacy of cognitive behavioral therapy (CBT) and multi-person systemic therapy (ST) specifically for social anxiety disorders, involving 32 patients diagnosed with the disorder.

The primary outcome will focus on changes in social anxiety symptoms after a maximum of 26 hours of therapy, with secondary outcomes assessing various aspects of psychological and social functioning over a follow-up period of 9 and 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial. Hunger, C., Hilzinger, R., Koch, T., et al.[2023]

A study involving 233 participants with social anxiety disorder (SAD) found that both disorder-specific (DS-CBT) and transdiagnostic (TD-CBT) cognitive behavior therapies delivered online resulted in significant reductions in SAD symptoms, with an average reduction of over 30%.

The therapies also effectively reduced symptoms of comorbid conditions like depression and generalized anxiety disorder, with improvements maintained or enhanced at a 24-month follow-up, indicating long-term efficacy of both treatment formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic versus disorder-specific and clinician-guided versus self-guided internet-delivered treatment for Social Anxiety Disorder and comorbid disorders: A randomized controlled trial. Dear, BF., Staples, LG., Terides, MD., et al.[2022]

In a randomized clinical trial with 86 young adults, both individual Trial-Based Cognitive Therapy (TBCT) and group Cognitive-Behavioral Therapy (Group CBT) significantly reduced symptoms of social anxiety and depression compared to a waitlist control group.

This study is the first to compare TBCT and Group CBT in Brazil, demonstrating that both interventions are effective in addressing social anxiety disorder and related psychiatric symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of group and individual Cognitive-Behavioral Therapy approaches for Social Anxiety Disorder. Neufeld, CB., Palma, PC., Caetano, KAS., et al.[2020]

Emotion Regulation Therapy (ERT) was effective in treating social anxiety disorder (SAD) in four clients who also had symptoms of generalized anxiety disorder (GAD) and depression, showing significant improvements in symptom severity and quality of life after 16 sessions.

The positive effects of ERT were maintained or even increased during follow-up assessments at 1, 2, and 3 months, suggesting that ERT may address underlying issues of emotion dysregulation and motivation in individuals with co-morbid SAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion regulation therapy for social anxiety disorder: a single case series study. Abasi, I., Pourshahbaz, A., Mohammadkhani, P., et al.[2021]

The study tested a brief, 5-session transdiagnostic treatment for anxiety disorders called F-SET, which significantly reduced anxiety (Cohen's d=2.01) and depression (Cohen's d=2.16) in 28 participants compared to a waitlist control group.

The effectiveness of F-SET was linked to a reduction in avoidance strategies, suggesting that targeting these behaviors can be a key mechanism for improving anxiety symptoms, making it a potentially low-cost and efficient therapy option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. Riccardi, CJ., Korte, KJ., Schmidt, NB.[2022]

A randomized clinical trial involving 46 participants demonstrated that a 12-week transdiagnostic cognitive-behavioral therapy (CBT) was as effective as traditional diagnosis-specific CBT for treating anxiety disorders like panic disorder, social anxiety disorder, and generalized anxiety disorder.

The study supports the use of transdiagnostic CBT as a viable treatment option, which could improve access to effective anxiety treatments without compromising efficacy, making it easier to disseminate these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic versus diagnosis-specific cbt for anxiety disorders: a preliminary randomized controlled noninferiority trial. Norton, PJ., Barrera, TL.[2022]

Transdiagnostic cognitive-behavioral therapy (CBT) is an adaptable treatment that can effectively address a variety of anxiety and emotional disorders, potentially improving accessibility for patients.

Clinical trials and meta-analyses indicate that transdiagnostic CBT is as effective as traditional CBT, and may be particularly beneficial for individuals with multiple anxiety and emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic Therapy. Norton, PJ., Roberge, P.[2018]

Transdiagnostic cognitive behavioral therapy (CBT) protocols have been developed to streamline treatment for affective disorders by combining overlapping components from various disorder-specific CBT approaches, potentially reducing the number of protocols needed.

These newer transdiagnostic treatments, such as group CBT for anxiety and the unified protocol for emotional disorders, aim to address multiple symptoms and comorbidities simultaneously, making CBT more accessible and cost-effective for both providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement towards transdiagnostic psychotherapeutic practices for the affective disorders. Gros, DF., Allan, NP., Szafranski, DD.[2018]

A study involving seven patients with social anxiety disorder showed that a brief cognitive behavior therapy (CBT) program of six sessions effectively reduced social anxiety symptoms in all participants.

While brief CBT improved overall social anxiety and self-consciousness, it did not significantly reduce fear of negative evaluation for all patients, indicating that some individuals may require longer treatment for deeper cognitive changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief cognitive behavior therapy in patients with social anxiety disorder: a preliminary investigation. Pinjarkar, RG., Sudhir, PM., Math, SB.[2020]

A manualized cognitive-behavioral therapy (CBT) treatment for social anxiety disorder (SAD) was implemented in a case study of a 26-year-old male, resulting in complete remission of his symptoms after 15 sessions.

Follow-up assessments at 2 and 8 months post-treatment showed that the remission of SAD symptoms was maintained, highlighting the long-term efficacy of this CBT approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manualized Cognitive-Behavioral Treatment of Social Anxiety Disorder: A Case Study. Shorey, RC., Stuart, GL.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial. [2023]

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

Internet-based psychodynamic therapy vs cognitive behavioural therapy for social anxiety disorder: A preference study. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Transdiagnostic versus disorder-specific and clinician-guided versus self-guided internet-delivered treatment for Social Anxiety Disorder and comorbid disorders: A randomized controlled trial. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of group and individual Cognitive-Behavioral Therapy approaches for Social Anxiety Disorder. [2020]

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

Emotion regulation therapy for social anxiety disorder: a single case series study. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. [2022]

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

Transdiagnostic versus diagnosis-specific cbt for anxiety disorders: a preliminary randomized controlled noninferiority trial. [2022]

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

Transdiagnostic Therapy. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Movement towards transdiagnostic psychotherapeutic practices for the affective disorders. [2018]

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

Brief cognitive behavior therapy in patients with social anxiety disorder: a preliminary investigation. [2020]

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

Manualized Cognitive-Behavioral Treatment of Social Anxiety Disorder: A Case Study. [2021]