Exposure Therapy for Social Anxiety Disorder

(METER Trial)

Overseen By Tomislav D Zbozinek, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Bipolar, Psychosis, Substance use, others

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

Compensation: Varies

Number of Visits: 3

94 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to either be medication-free or stabilized on their current psychotropic medications for a certain period (1 month for benzodiazepines and beta blockers, 3 months for SRIs/SNRIs and heterocyclics) before joining.

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

Research shows that exposure therapy, often used as part of cognitive-behavioral therapy (CBT), is effective in treating social anxiety disorder. Studies indicate that combining exposure therapy with cognitive therapy can lead to significant improvements in managing social anxiety. ^{1 2 3 4 5}

Is exposure therapy safe for treating social anxiety disorder?

Exposure therapy is generally considered safe for treating conditions like PTSD and social anxiety disorder when conducted by experienced therapists, as it involves confronting fears in a controlled and supportive environment. ^{4 6 7 8 9}

How does Exposure Therapy for Social Anxiety Disorder differ from other treatments?

Exposure Therapy for Social Anxiety Disorder is unique because it directly involves facing social situations that cause anxiety, helping individuals gradually become less sensitive to these triggers. This approach is often combined with Positive Affect Treatment - Behavioral (PAT-B) and Relaxation Treatment, which aim to enhance positive emotions and reduce stress, offering a comprehensive strategy that differs from traditional cognitive-behavioral therapy (CBT) by focusing more on emotional and relaxation components. ^{1 2 6 10 11}

What is the purpose of this trial?

The investigators are conducting a clinical trial of therapy for public speaking anxiety. There are many eligibility criteria, but the main ones are that participants need to be socially anxious and have public speaking anxiety. In this clinical trial, all participants will do exposure therapy. Before doing exposure therapy in the study, though, participants will be randomized to do one of two treatments: i) a positive mood treatment, which is designed to increase how positive people feel, and ii) a relaxation treatment, which is designed to help people feel more relaxed. The investigators are doing this study to see whether doing the positive mood treatment or relaxation treatment first will affect how well exposure therapy works.

Research Team

Tomislav D Zbozinek, PhD

Principal Investigator

University of California, Los Angeles

Michelle G Craske, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for individuals who experience social anxiety, particularly with public speaking. Participants must be anxious in social situations and should not have other psychological conditions that could interfere with the treatment.

Inclusion Criteria

Elevated fear of public speaking, defined as a score of >= 66 on the Public Speaking Anxiety Scale (PSAS)

Fluent in English

To conduct MRI version of fear conditioning task, must have no MRI contraindications

Exclusion Criteria

Substance use disorder within the last 6 months

Pregnant or planning to become pregnant for next 6 months

Lifetime history of suicide attempts

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomized to either Positive Affect Treatment - Behavioral (PAT-B) or Relaxation Treatment to address reward processing and anhedonia or to promote relaxation.

6 weeks

Sessions 1-8 (in-person)

Exposure Therapy

Participants undergo exposure therapy to reduce public speaking anxiety.

4 weeks

Sessions 1-8 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

12 weeks

1 visit (in-person)

Treatment Details

Interventions

• Exposure Therapy
• Positive Affect Treatment - Behavioral (PAT-B)
• Relaxation Treatment

Trial Overview The study tests if a positive mood treatment (PAT-B) or relaxation therapy affects the success of subsequent exposure therapy for social anxiety disorder related to public speaking.

Participant Groups

Group I: Positive Affect Treatment - Behavioral (PAT-B) Experimental Treatment 2 Interventions

Focused on improving reward processing and anhedonia using PAT-B. Expected to reduce negative affect and increase positive affect. Then, exposure therapy to reduce public speaking anxiety.

Group II: Relaxation Treatment Active Control 2 Interventions

Focused on relaxation and mindfulness using Relaxation Treatment. Expected to reduce negative affect. Then, exposure therapy to reduce public speaking anxiety.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Cognitive-behavioral therapy (CBT) is effective for treating social anxiety disorder (SAD), with individual cognitive therapy showing the largest effect sizes among various CBT approaches.

Recent research highlights the importance of emotion regulation and fear extinction in achieving positive treatment outcomes, and internet-delivered CBT offers a promising way to increase access to these effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Developments in Cognitive-Behavioral Therapy for Social Anxiety Disorder. Stangier, U.[2018]

Short-term effectiveness was found for non-drug treatments like social skills training, exposure therapy, and cognitive therapy in managing social phobia, with a combination of exposure and cognitive therapy showing potential superiority.

While therapies led to stable results over follow-up periods, more research is needed to compare cognitive behavior therapy with medication and to explore the effectiveness of self-help manuals in treatment combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-drug treatment for social phobia. van Dyck, R.[2019]

Cognitive-behavioral therapy (CBT) for social anxiety disorder focuses on cognitive restructuring and exposure interventions, which have been shown to lead to both immediate improvements and sustained benefits over time.

The review highlights the effectiveness of these CBT strategies based on individual studies and meta-analyses, suggesting that they are crucial for understanding and treating social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for social anxiety disorder: model, methods, and outcome. Otto, MW.[2018]

Recent advances in cognitive-behavioral therapy (CBT) for social phobia have led to the development of a new psychobiological model, enhancing understanding and treatment of the condition.

Controlled clinical trials have shown that the authors' CBT approach is effective, and future research will explore combining drug therapy with behavioral therapy and intensive treatments for avoidant personality disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in cognitive-behavioral therapy for social phobia. Heimberg, RG., Barlow, DH.[2018]

Exposure-based cognitive-behavioral therapy (CBT) is effective in treating social anxiety disorder (SAD), supported by strong evidence.

The article outlines a four-step CBT approach tailored for SAD, emphasizing strategies like shifting attention from internal to external cues and correcting negative thought patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy for treatment of social anxiety disorder]. Inoue, K.[2018]

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]

Participants with severe spider phobia who completed an additional exposure step (allowing a spider to walk on them) experienced greater reductions in fear and harmful beliefs compared to those who completed fewer steps, indicating that more intense exposure therapy can be more effective.

Although fear may return after a change in context, those who completed the more intense exposure step maintained better tolerance to their fear, suggesting that challenging harmful beliefs can lead to longer-lasting improvements in managing phobias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Scarier the Better: Maximizing Exposure Therapy Outcomes for Spider Fear. Norberg, MM., Newins, AR., Jiang, Y., et al.[2019]

Exposure therapy is a safe and effective treatment for Posttraumatic Stress Disorder (PTSD), supported by strong evidence from well-controlled studies across various trauma populations.

Despite its effectiveness, misconceptions about exposure therapy may hinder its broader acceptance, highlighting the importance of proper application by experienced therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure therapy for posttraumatic stress disorder. Rothbaum, BO., Schwartz, AC.[2018]

In a study involving 30 participants with social phobia, those who received additional instructions to drop 'safety behaviours' during cognitive-behaviour therapy (CBT) showed significant improvement in their social phobia symptoms compared to those who did not.

This finding supports the cognitive model of social phobia, suggesting that avoiding safety behaviours can enhance the effectiveness of exposure tasks in CBT, although further research with larger groups is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does reducing safety behaviours improve treatment response in patients with social phobia? Morgan, H., Raffle, C.[2018]

Both brief cognitive-behavioral therapy (bCBGT) and verbal exposure augmented cognitive behavioral therapy (VE-CBT) significantly reduced social anxiety symptoms in university students diagnosed with social anxiety disorder (SAD) after six weekly sessions, as measured by multiple scales.

bCBGT was found to be more effective than VE-CBT, showing superior results in reducing social anxiety severity at both post-treatment and two-month follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Group Therapy and Verbal-Exposure-Augmented Cognitive Behavioral Therapy for Social Anxiety Disorder in University Students: A Randomized Controlled Feasibility Trial. Singh, P., Samantaray, NN.[2022]

Social phobia affects about 13% of adults in the U.S. and is a chronic condition that typically requires intervention for significant improvement, highlighting the need for effective long-term treatments.

Cognitive-behavioral group therapy (CBGT), which combines exposure and cognitive restructuring, has shown lasting efficacy, with patients maintaining improvements even five years post-treatment, although the exact components that contribute to its effectiveness remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social phobia. Longitudinal course and long-term outcome of cognitive-behavioral treatment. Juster, HR., Heimberg, RG.[2018]

References

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

New Developments in Cognitive-Behavioral Therapy for Social Anxiety Disorder. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Non-drug treatment for social phobia. [2019]

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

Cognitive-behavioral therapy for social anxiety disorder: model, methods, and outcome. [2018]

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

New developments in cognitive-behavioral therapy for social phobia. [2018]

5. Japan pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy for treatment of social anxiety disorder]. [2018]

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

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

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

The Scarier the Better: Maximizing Exposure Therapy Outcomes for Spider Fear. [2019]

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

Exposure therapy for posttraumatic stress disorder. [2018]

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

Does reducing safety behaviours improve treatment response in patients with social phobia? [2018]

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

Brief Cognitive Behavioral Group Therapy and Verbal-Exposure-Augmented Cognitive Behavioral Therapy for Social Anxiety Disorder in University Students: A Randomized Controlled Feasibility Trial. [2022]

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

Social phobia. Longitudinal course and long-term outcome of cognitive-behavioral treatment. [2018]