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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different treatments might help people with social anxiety, particularly those who fear public speaking. Participants will first receive either a mood-boosting treatment to increase positivity or a relaxation treatment to promote calmness. Afterward, everyone will undergo exposure therapy, which involves gradually facing fears to reduce anxiety. The researchers aim to determine if starting with mood or relaxation treatments affects the success of exposure therapy. This trial seeks individuals with social anxiety who are especially anxious about public speaking. As an unphased trial, it offers a unique opportunity to contribute to understanding and improving treatments for social anxiety.

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.

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

Research shows that both Positive Affect Treatment - Behavioral (PAT-B) and Relaxation Treatment are generally safe. Studies have found that PAT-B, which boosts positive feelings, can help reduce anxiety and is usually well-tolerated. Similarly, relaxation techniques often ease stress and anxiety and are generally considered safe.

No serious side effects have been reported for either treatment. Participants often feel less anxious and depressed during these therapies, suggesting the treatments are likely safe and manageable for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for social anxiety disorder because they tackle the issue in innovative ways. The Positive Affect Treatment - Behavioral (PAT-B) aims to enhance reward processing and reduce anhedonia, which could increase positive emotions and counteract the negative feelings often associated with social anxiety. Unlike standard treatments that usually focus on reducing anxiety symptoms through medication or cognitive-behavioral therapy, PAT-B specifically targets the emotional and motivational deficits linked to the disorder. Meanwhile, the Relaxation Treatment combines mindfulness and relaxation techniques to reduce negative emotions, offering a potentially calming and holistic approach before diving into exposure therapy for public speaking anxiety. These strategies represent a fresh perspective in treating social anxiety, focusing on emotional and mental well-being.

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

Research has shown that exposure therapy can reduce social anxiety, particularly regarding public speaking. By gradually introducing individuals to anxiety-inducing situations, they can become less nervous over time. In this trial, participants may receive different treatments. The Positive Affect Treatment - Behavioral (PAT-B) aims to improve emotional well-being, but results have varied; in one study, only two out of seven participants felt better, while others did not. However, this treatment might still help lessen negative feelings. Another group will receive Relaxation Treatment, which uses calming techniques and has helped some people feel less anxious. Combining these methods with exposure therapy might enhance its effectiveness in reducing anxiety about public speaking. ^{2 3 6 7 8}

Who Is on the Research Team?

Tomislav D Zbozinek, PhD

Principal Investigator

University of California, Los Angeles

Michelle G Craske, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/25/NCT06132425/Prot_SAP_000.pdf

Clinical Trials Protocol for “Reward Processes and Rehearsal in ... Study Description: The purpose of this study is to 1) examine the importance of self-reported relief following exposure and 2) test whether positive-focused ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6866675/

Examining positive and negative affect as outcomes and ... Positive affect was found to improve in only two of seven participants, and worsened in five of seven – even as negative affect improved over the course of ...

3. trialstoday.org trialstoday.org/list/print/NCT06776991

Reward Processing and Exposure Therapy for Social ... Expected to reduce negative affect and increase positive affect. Then, exposure therapy to reduce public speaking anxiety. Behavioral: Positive ...

4. withpower.com withpower.com/trial/phase-anxiety-disorders-or-anxiety-and-phobic-neuroses-8-2024-5c3a0?condition=Anhedonia&overallStatus=Recruiting&hasNoPlacebo=false

Exposure Therapy for Social Anxiety Disorder (METER Trial) 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724000971

Review Article Positive and negative affect change ... Current psychotherapeutic interventions for anxiety-related disorders may not improve PA and NA to comparable levels.

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/573460

Reward Processing and Exposure Therapy for Social Anxiety ... The investigators are doing this study to see whether doing the positive mood treatment or relaxation treatment first will affect how well exposure therapy ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9246012/

Examining the Link Between Positive Affectivity and ... Results: Across all participants, higher PA significantly predicted lower anticipatory anxiety and less anxiety-related behavior, beyond level ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2950004423000044

A randomized clinical trial of behavioral activation and ... Compared to EXP, BA yielded more rapid declines in anxiety and depression scores during therapy (d=0.75–0.77), as well as lower anxiety and depression scores (d ...