Accepted for/Published in: JMIR Mental Health
Date Submitted: Mar 13, 2025
Date Accepted: Aug 16, 2025
Underpowered results from the SoREAL Pragmatic Randomized Clinical Trial: Group Cognitive Behavioral Therapy with Virtual Reality Exposure Versus In-Vivo Exposure for Social Anxiety Disorder and Agoraphobia
ABSTRACT
Background:
Social anxiety disorder (SAD) and agoraphobia are common, impairing conditions often treated with cognitive behavioral therapy (CBT), in which exposure therapy is a core element. Virtual reality exposure (VRE) has shown promise as a flexible alternative to in-vivo exposure.
Objective:
This trial evaluated the efficacy of group CBT with VRE (VR-CBT) versus CBT with in-vivo exposure for treating SAD and agoraphobia in clinical settings.
Methods:
In this randomized, parallel-group, assessor-blinded trial, 177 participants with SAD or agoraphobia were assigned to either VR-CBT or traditional CBT across five Danish mental health outpatient clinics. Both groups received 14 weekly group sessions. Primary outcomes were phobic anxiety reductions, measured by the Liebowitz Social Anxiety Scale (LSAS) and the Mobility Inventory for Agoraphobia (MIA). Secondary outcomes included work and social functioning, depressive symptoms, and quality of life.
Results:
Both groups showed significant reductions in primary, secondary, and exploratory outcomes, with no significant differences between groups. Baseline characteristics and attrition rates were balanced across groups.
Conclusions:
Due to insufficient recruitment and substantial missing data, no definitive conclusions can be drawn regarding group differences between VR-CBT and traditional CBT in group settings. The feasibility issues encountered suggest that careful consideration of the benefits and limitations of VR technology is essential before implementation in clinical practice. Clinical Trial: NCT03845101
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