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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach called Very Brief Exposure (VBE) therapy to assist teens and young adults with social anxiety disorder (SAD). Researchers aim to determine how brief exposure to various facial expressions affects brain activity and helps regulate emotions and attention. Participants will view images while undergoing brain scans to measure fear responses and brain activity related to emotion control. Individuals aged 16 to 22 with diagnosed social anxiety disorder may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatments for social anxiety disorder.

Will I have to stop taking my current medications?

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

What prior data suggests that this method is safe for youth with social anxiety disorder?

Research has shown that exposure therapy is generally safe and effective in reducing anxiety symptoms. In several studies, participants experienced a significant decrease in anxiety levels. For example, one study found that most participants felt comfortable with the treatment, with only a few experiencing discomfort. Additionally, early findings suggest that exposure therapy, particularly when involving real-life social situations, outperforms some traditional therapy methods. Overall, exposure therapy has a strong track record of safety and effectiveness in treating social anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for social anxiety disorder, such as cognitive-behavioral therapy (CBT) and medications like SSRIs, Very Brief Exposure focuses on quick, targeted exposure to social cues. Participants view images of diverse facial expressions on a computer screen, which helps them rate and process social information differently. Researchers are excited about this method because it offers a non-invasive, rapid approach that could potentially reduce anxiety without the need for long-term medication or extensive therapy sessions.

What evidence suggests that Very Brief Exposure is effective for social anxiety disorder?

Research shows that very brief exposure (VBE) therapy, which participants in this trial will experience, can effectively reduce social anxiety. Studies have demonstrated that short exercises involving imagined social situations can help lower anxiety. For example, several studies found significant reductions in anxiety symptoms after using exposure therapy. One study noted that these brief exercises were especially helpful for anxiety related to social interactions. Overall, exposure therapy has a strong history of easing symptoms of social anxiety disorder, offering hope for those seeking relief. ^{1 6 7 8 9}

Who Is on the Research Team?

Bradley S. Peterson, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

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

Ferromagnetic implants, metal braces, retainers, tattoos with metallic content, transdermal medicinal patches that cannot be removed

My primary language is neither English nor Spanish.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10493899/

Brief Imaginal Exposure Exercises for Social Anxiety Disorder

Findings suggest that a brief IE self-help intervention was effective in targeting social interaction anxiety. Keywords: anxiety, self-efficacy, exposure, ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0887618523000877

Brief imaginal exposure exercises for social anxiety disorder

This study examined the efficacy and effectiveness of 7-day IE exercises (vs. active control) on individuals with social anxiety related to social interactions.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10242975/

A scoping review investigating the use of exposure for the ...

All four studies showed significant reductions in anxiety symptoms following exposure. For example, in vivo exposure was effective in ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0887618524000574

The efficacy of psychotherapy for social anxiety disorder, a ...

Psychotherapy was effective in reducing SAD symptoms, with a large effect size (g = 0.88; 95 % CI: 0.76 to 1.0; I2 = 74 %; 95 % CI: 69 to 79, NNT = 3.8).

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04850989

Efficacy of Virtual Reality Exposure Therapy Scripts for ...

An early study showed that four therapist-facilitated 12-to-15-minute sessions of VRE (vs. WL) efficaciously reduced public speaking phobia for highly anxious ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4238930/

Social Mishap Exposures for Social Anxiety Disorder

Early data suggest that treatment protocols that incorporate social mishap exposures show considerably greater efficacy than traditional CBT protocols, which ...

7.

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 ...

8.

link.springer.com

link.springer.com/article/10.1007/s10826-023-02536-w

What Works in Preventing Emerging Social Anxiety

Exposure had a positive effect on social anxiety, distress, avoidant behavior, positive thoughts, perceived social threat, internalizing ...

9.

mental.jmir.org

mental.jmir.org/2019/6/e13869/

Exposure Therapy With Personalized Real-Time Arousal ...

Results: Most participants found the intervention acceptable (82.0%, 95% CI 69.0%-91.0%). Seven (14.9%, 95% CI 7.0%-28.0%) participants reported ...