Very Brief Exposure for Social Anxiety Disorder
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Hospital Los Angeles
Must not be taking: Psychoactive medications
Disqualifiers: OCD, Bipolar, Autism, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
12356How 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.
12378Eligibility 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)
+15 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Image Exposure ArmExperimental Treatment1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
Children's Hospital Los AngelesLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Non-drug treatment for social phobia. [2019]When controlled studies on currently available non-drug treatments for social phobia were reviewed, short-term effectiveness was evident for social skills training, exposure therapy and cognitive therapy. The combination of exposure and cognitive therapy may have some superiority over the separate treatments. Group therapy and individual therapy did not differ clearly in outcome, while attempts to match treatment and patient characteristics have so far failed to produce consistently better results. With follow-up periods of either less than a year or more than a year, the therapies reviewed appeared to lead to stable results, although the available data allowed no firm conclusions because of attrition and additional treatments during the follow-up period. Except for the recent landmark study by Heimberg and Liebowitz, cognitive behavior therapy has not been adequately compared to medication. Studies are needed to assess the value of cognitive behavior therapy in combination with medication and to explore the possibilities of self-help manuals in such combination studies.
Appropriate Number of Treatment Sessions in Virtual Reality-Based Individual Cognitive Behavioral Therapy for Social Anxiety Disorder. [2021]Virtual reality (VR) was introduced to maximize the effect of cognitive behavioral therapy (CBT) by efficiently performing exposure therapy. The purpose of this study was to find out whether VR-based individual CBT with relatively few treatment sessions is effective in improving social anxiety disorder (SAD). This therapy was applied to 115 patients with SAD who were retrospectively classified into 43 patients who completed the nine or 10 sessions normally (normal termination group), 52 patients who finished the sessions early (early termination group), and 20 patients who had extended the sessions (session extension group). The Brief Fear of Negative Evaluation Scale (BFNE) scores tended to decrease in all groups as the session progressed, and the slope of decrease was the steepest in the early termination group and the least steep in the session extension group. Severity of social anxiety in the last session and symptom reduction rate showed no significant group difference. Our findings suggest that short-term VR-based individual CBT of nine to 10 sessions may be effective. When the therapeutic effect is insufficient during this period, the additional benefit may be minimal if the session is simply extended. The improvement in the early termination group suggests that even shorter sessions of five or six can also be effective.
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]Considering the need for developing and examining evidenced-based programs using a brief group format for management of social anxiety disorder (SAD) at the community level, we studied the efficacy of two brief versions of cognitive-behavioral therapy (CBT) programs, brief cognitive-behavioral group therapy (bCBGT), and verbal exposure augmented cognitive behavioral therapy (VE-CBT), on social anxiety among university students.
Cognitive-behavioral therapy for social anxiety disorder: model, methods, and outcome. [2018]Cognitive-behavioral therapy for social anxiety disorder has typically emphasized cognitive-restructuring and exposure interventions, delivered alone or in combination, in either individual or group formats. Treatment programs emphasizing these interventions are associated with both acute improvements and longer term maintenance of treatment gains. In this article, the nature and application of these interventions are reviewed in relation to a cognitive-behavioral model of the development and maintenance of social anxiety disorder. Strategies for change and outcome findings are discussed, with attention to both individual studies and meta-analytic reviews of the literature. Strategies for improving outcomes and future directions for research are also discussed.
New Developments in Cognitive-Behavioral Therapy for Social Anxiety Disorder. [2018]Social anxiety disorder (SAD) is a highly prevalent and chronic disorder that causes considerable psychosocial impairment. This article reviews recent changes in the definition of SAD in DSM-5 and summarizes the current evidence for effective cognitive-behavioral treatments in adults, children, and adolescents. Current data suggests that cognitive-behavioral therapy (CBT) is efficacious in the treatment of this condition. Among different CBT approaches, individual cognitive therapy may be associated with the largest effect sizes. In this review, interventions targeting dysfunctional cognitive processes that contribute to the effective treatment of SAD are discussed. Some recent findings from neuroimaging research and studies on the augmentation of CBT using neuroenhancers indicate that changes in emotion regulation as well as fear extinction are important psychological mediators of positive outcome. Furthermore, internet-delivered CBT is a promising field of technological innovation that may improve access to effective treatments. Despite the availability of effective treatments, treatment-resistant SAD remains a common problem in clinical practice that requires more research efforts. Finally, potential areas for further development of CBT as well as its dissemination in health care are summarized.
Pilot randomized trial of self-guided virtual reality exposure therapy for social anxiety disorder. [2022]Virtual reality exposure therapy (VRE) has shown promising efficacy for the treatment of social anxiety disorder (SAD) and related comorbidities. However, most trials conducted to date were therapist-led, and little is known about the efficacy of self-guided VRE. Therefore, this randomized controlled trial (RCT) aimed to determine the efficacy of a self-directed VRE for SAD.
A demonstration of the efficacy of two of the components of cognitive therapy for social phobia. [2021]Cognitive-behavioral treatments have demonstrated efficacy in the treatment of social phobia. However, such treatments comprise a complex set of procedures, and there has been little investigation of the effects of individual procedures. The current study investigates the effects of two single session procedures that form part of cognitive therapy for social phobia [Clark, D., Ehlers, A., McManus, F., Hackmann, A., Fennell, M., Campbell, H., et al. (2003). Cognitive therapy vs fluoxetine in the treatment of social phobia: A randomised placebo controlled trial. Journal of Consulting and Clinical Psychology, 71, 1058-1067; Clark, D., Ehlers, A., McManus, F., Fennell, M., Grey, N., Waddington, L., et al. (2006). Cognitive therapy versus exposure and applied relaxation in social phobia: A randomised controlled trial. Journal of Consulting and Clinical Psychology, 74, 568-578], namely the "self-focused attention and safety behaviors experiment" and the "video feedback experiment." Results suggest that both procedures are effective in achieving their aims, which are: (i) demonstrating to patients the role of self-focused attention, safety behaviors, and excessively negative self-impressions in maintaining social phobia and (ii) reducing the symptoms of social phobia.
Virtual reality-based cognitive behavioural therapy for patients with generalized social anxiety disorder: a pilot study. [2022]Patients with generalized social anxiety disorder (SAD) avoid various social situations and can be reluctant to engage in in vivo exposure therapy. Highly personalized practising can be required before patients are ready to perform in vivo exposure. Virtual reality-based therapy could be beneficial for this group.