Virtual Reality for AnxIety Disorders - Randomized Controlled Trial

Summary

Social anxiety disorder (SAD) has a high prevalence and an early onset and has a lengthy recovery period often taking decades to occur. Current evidence supports the efficacy of cognitive behavioral therapy (CBT) with virtual reality (VR) exposure. However, the evidence is based on a small number of studies.

This trial examines the efficacy of an intervention that combines CBT with individually tailored exposure in VR. During exposure, participants' anxiety level is estimated in real time based on heart rate and electrodermal activity. Estimated anxiety level can guide the therapist's adjustment of the VR content. The above treatment is compared with the gold standard treatment for SAD which is cognitive behavioral therapy with exposure conducted in real life. Treatment is individual, manual-based and consists of 10 weekly sessions with a duration of 60 minutes.

The aim of the study is to investigate whether CBT combined with exposure in VR (adapted on the basis of estimated anxiety level) is more effective than CBT with exposure in real life.

The trial is a randomized controlled trail (RCT). The study includes 90 participants diagnosed with SAD. Assessments are carried out pre-treatment, mid-treatment and at follow-up (6 and 12 months).

The primary outcome of the study is self-reported symptoms of social anxiety using Social Interaction Anxiety Scale. The primary endpoint is post-treatment.

Conditions

• Social Anxiety
• Social Phobia

Interventions

BEHAVIORAL

Cognitive behavioral therapy with exposure in virtual reality

The treatment rationale is based on a model of the maintenance of social phobia by Clark and Wells. The themes of therapy are: a) The general ideas of CBT, b) The maintaining processes of social phobia, c) negative automatic thoughts, d) shifting focus of attention form self-focus to external focus, e) safety behaviors, f) post-processing, g) self-processing, h) schemas and rules for living. Exposure in VR: We will use 360° 3D videos for exposure using an HTC Vive Pro headset. Six different videos will be used for exposure: 1) Taking a seat on a bench in a public park, 2) Being introduced as a new employee, 3) Performing a presentation at a meeting, 4) Entering and shopping in a grocery store, 5) Visiting a café and 6) Using public transportation. The therapist can choose the length of the exposure as well as the difficulty of the exposure. While the participant is in the VR-scenario HR and EDA are measured. These data are collected to continuously estimate the anxiety levels.

BEHAVIORAL

Cognitive behavioral therapy with exposure in vivo

The treatment rationale is based on a model of the maintenance of social phobia by Clark and Wells.The themes of therapy are: a) The general ideas of CBT, b) The maintaining processes of social phobia, c) negative automatic thoughts, d) shifting focus of attention form self-focus to external focus, e) safety behaviors, f) post-processing, g) self-processing, h) schemas and rules for living. Exposure in vivo: Exposure is taking place at Centre for Telepsychiatry and the surrounding areas. The therapist is planning the exposure with the participant and is accompanying the participant during the exposure.

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Universite du Quebec en Outaouais

  collaborator OTHER

• IMotions A/S

  collaborator INDUSTRY

• Region of Southern Denmark

  lead OTHER

Principal Investigators

• Per Trads Ørskov, Ph.d. · Region of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-31

Primary Completion

2025-01-04

Completion

2025-01-04

Countries

• Denmark

Study Locations