Clinical Trials Logo
  1. Home
  2. Social Anxiety Disorder
  3. NCT03845101

CBT Versus CBT With Virtual Reality Exposure for Social Anxiety Disorder and Agoraphobia — SoREAL  

Social Anxiety Disorder Clinical Trial

Official title:
SoREAL- a Randomized Clinical Trial

Clinical Trial Summary

Introduction: Anxiety disorders have a high lifetime prevalence, early-onset, and long duration or chronicity. Exposure therapy is considered one of the most effective elements in cognitive behavioral therapy (CBT) for anxiety, but in vivo exposure can be challenging to access and control, and is sometimes rejected by patients because they consider it too aversive. Virtual reality allows flexible and controlled exposure to challenging situations in an immersive and protected environment. Aim: The SoREAL-trial aims to investigate the effect of group cognitive-behavioral therapy (CBT-in vivo) versus group cognitive behavioral therapy with virtual reality exposure (CBT-in virtuo) for patients diagnosed with social anxiety disorder and/or agoraphobia, in mixed groups. Methods & Analysis: The design is an investigator-initiated randomized, assessor-blinded, parallel-group and superiority-designed clinical trial. Three hundred two patients diagnosed with social anxiety disorder and/or agoraphobia will be included from the regional mental health centers of Copenhagen and North Sealand and the Northern Region of Denmark. All patients will be offered a manual-based 14-week cognitive behavioral group treatment program, including eight sessions with exposure therapy. Therapy groups will be centrally randomized with concealed allocation sequence to either CBT-in virtuo or CBT-in vivo. Patients will be assessed at baseline, post-treatment and one-year follow-up by treatment blinded researchers and research assistants. The primary outcome will be diagnosis-specific symptoms measured with the Liebowitz Social Anxiety Scale for patients with social anxiety disorder and the Mobility Inventory for Agoraphobia for patients with agoraphobia. Secondary outcome measures will include depression symptoms, social functioning, and patient satisfaction. Exploratory outcomes will be substance and alcohol use, working alliance and quality of life. Ethics and dissemination: The trial has been approved by the research ethics committee in the Capital Region of Denmark. All results, positive, negative as well as inconclusive, will be published as quickly as possible and still in concordance with Danish law on the protection of confidentially and personal information. Results will be presented at national and international scientific conferences.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03845101
Study type Interventional
Source Mental Health Services in the Capital Region, Denmark
Contact Benjamin Arnfred
Phone 21630878
Email benjamin.alexander.thorup.arnfred@regionh.dk
Status Recruiting
Phase N/A
Start date February 19, 2019
Completion date April 9, 2024
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06274112 - Using TMS to Understand Neural Processes of Social Motivation N/A
Completed NCT02554929 - Treatment of Social Anxiety Disorder and Selective Mutism N/A
Completed NCT00684541 - Interpretation Modification Program for Social Phobia N/A
Completed NCT00684320 - Attention Disengagement Training for Social Phobia N/A
Completed NCT03247075 - Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT N/A
Completed NCT02811458 - Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders N/A
Withdrawn NCT04622930 - Waitlist-Control Trial of Smartphone CBT for Social Anxiety Disorder (SAD) N/A
Active, not recruiting NCT05018312 - Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety N/A
Active, not recruiting NCT05124639 - Clinical Trial of a Group Self-management Support Program for Anxiety Disorders N/A
Completed NCT05858294 - The Safety, Acceptability and Efficacy of Alena N/A
Active, not recruiting NCT05600114 - Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder Phase 2
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Not yet recruiting NCT02924610 - Brief Intervention to Reduce Fear Phase 4
Active, not recruiting NCT02592564 - Brain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder N/A
Recruiting NCT02305537 - Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment N/A
Terminated NCT03764644 - Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders N/A
Unknown status NCT01712321 - Study of Vilazodone to Treat Social Anxiety Disorder N/A
Completed NCT01320800 - CBT for Social Anxiety Disorder Delivered by School Counselors Phase 2
Completed NCT00773162 - Flushing in Social Anxiety Disorder on Seroquel Phase 3
Completed NCT00485615 - An Open Label Trial of Omega 3(o3mega+Joy)in the Treatment of Social Phobia Phase 2