Very Brief Exposure for Social Anxiety Disorder

Overseen By Bradley S Peterson, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Must not be taking: Psychoactive medications

Disqualifiers: OCD, Bipolar, Autism, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, participants cannot be on any current psychoactive medication to join this trial.

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

Research shows that exposure therapy, which is a key part of Very Brief Exposure Therapy, is effective in treating social anxiety disorder. Studies have found that even short-term exposure therapy can lead to improvements in social anxiety symptoms. ^{1 2 3 4 5}

Is Very Brief Exposure Therapy safe for humans?

The research articles reviewed do not provide specific safety data for Very Brief Exposure Therapy, but they suggest that exposure therapy, in general, is considered safe and effective for treating social anxiety disorder. ^{1 2 3 5 6}

How is Very Brief Exposure Therapy different from other treatments for social anxiety disorder?

Very Brief Exposure Therapy is unique because it involves shorter, more focused sessions compared to traditional therapies, potentially making it more accessible and less time-consuming for patients while still effectively reducing social anxiety symptoms. ^{1 2 3 7 8}

What is the purpose of this trial?

The goal of this clinical trial is to identify the circuit activations by very brief exposure (VBE) among youth with social anxiety disorder (SAD) in order to develop a novel intervention for those with SAD. The secondary objectives of this study are to measure the effect of VBE on subjective fear ratings, and participants' awareness and tolerance of the exposure stimuli. * The primary outcome of this study is the mean activation of frontostriatal and prefrontal brain regions to facial stimuli, as measured by Blood Oxygen Level Dependent (BOLD) response, in 4 regions of interest during the magnetic resonance imaging (MRI). * Another primary outcome of the study is to identify networks of regions subserving emotion regulation and attention, as measured by BOLD response of corresponding brain regions. Secondary Outcomes -The secondary outcome of this study is the fear induced by exposure to facial expression stimuli as measured by a 4-point fear scale during the functional magnetic resonance imaging (fMRI) after each block of 10 facial expression stimuli trials. Participants will participate in an interview where they will answer questions both inside and outside of the MRI scan. Participants will be asked to rate on a scale the imagines they see while undergoing MRI scan.

Research Team

Bradley S. Peterson, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

This trial is for transition-age youth with social anxiety disorder (SAD). Participants will be involved in an interview and MRI scans where they'll rate images of facial expressions. Key eligibility details are not provided, so interested individuals should inquire about specific inclusion and exclusion criteria.

Inclusion Criteria

I am between 16 and 22 years old.

I am a parent/caregiver and speak English or Spanish.

I am between 16 and 22 years old and have been diagnosed with Social Anxiety Disorder.

Exclusion Criteria

Active suicidality on the Colombia-Suicide Severity Scale

Active suicidality on the Colombia-Suicide Severity Scale

Current severe substance abuse (except tobacco/nicotine)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Image Exposure

Participants will see various images of facial expressions on a computer screen and provide various rating scores about them.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Very Brief Exposure

Trial Overview The study tests a new method called Very Brief Exposure (VBE) to see how it affects brain activity related to fear and attention in young people with SAD. It involves measuring brain responses using MRI while participants view facial expressions.

Participant Groups

Group I: Image Exposure Arm Experimental Treatment 1 Intervention

Participants will see various images of facial expressions on a computer screen and provide various rating scores about them.

Very Brief Exposure is already approved in United States for the following indications:

Approved in United States as Very Brief Exposure Therapy for:

• Post-traumatic stress disorder (PTSD)

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

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]

A study involving 115 patients with social anxiety disorder (SAD) found that short-term virtual reality (VR)-based cognitive behavioral therapy (CBT) of nine to 10 sessions can effectively reduce anxiety symptoms, as measured by the Brief Fear of Negative Evaluation Scale (BFNE).

Interestingly, patients who completed their sessions early showed the most significant improvement, indicating that even shorter treatment durations of five to six sessions may still be beneficial for managing SAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appropriate Number of Treatment Sessions in Virtual Reality-Based Individual Cognitive Behavioral Therapy for Social Anxiety Disorder. Jeong, HS., Lee, JH., Kim, HE., et al.[2021]

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]

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]

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]

A randomized controlled trial with 44 adults diagnosed with social anxiety disorder showed that self-guided virtual reality exposure therapy (VRE) significantly reduced symptoms of social anxiety, job interview fear, and trait worry, with moderate-to-large effect sizes from pre-to-post treatment.

The benefits of VRE were maintained at both 3-month and 6-month follow-ups, indicating its potential as an effective self-directed treatment for social anxiety disorder, while also improving aspects of user experience like presence and reducing cybersickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of self-guided virtual reality exposure therapy for social anxiety disorder. Zainal, NH., Chan, WW., Saxena, AP., et al.[2022]

The study found that two specific cognitive-behavioral procedures—self-focused attention and safety behaviors experiment, and video feedback experiment—are effective in helping patients understand and reduce their social phobia symptoms.

Both procedures successfully demonstrated how self-focused attention and negative self-impressions contribute to social phobia, leading to a reduction in symptoms for the patients involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A demonstration of the efficacy of two of the components of cognitive therapy for social phobia. McManus, F., Clark, DM., Grey, N., et al.[2021]

A pilot study involving 15 patients with severe generalized social anxiety disorder (SAD) showed that virtual reality-based cognitive behavioral therapy (VR-CBT) is feasible and can lead to significant improvements in social anxiety and quality of life after treatment.

Improvements in social anxiety and depressive symptoms were maintained at a 6-month follow-up, indicating that VR-CBT may be an effective long-term treatment option for patients reluctant to engage in traditional exposure therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality-based cognitive behavioural therapy for patients with generalized social anxiety disorder: a pilot study. Geraets, CNW., Veling, W., Witlox, M., et al.[2022]

References

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

Non-drug treatment for social phobia. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Appropriate Number of Treatment Sessions in Virtual Reality-Based Individual Cognitive Behavioral Therapy for Social Anxiety Disorder. [2021]

3. 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]

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

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

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

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

6. England pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of self-guided virtual reality exposure therapy for social anxiety disorder. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A demonstration of the efficacy of two of the components of cognitive therapy for social phobia. [2021]

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

Virtual reality-based cognitive behavioural therapy for patients with generalized social anxiety disorder: a pilot study. [2022]