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

Study Overview
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Brief Summary
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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.

Official Title
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SoREAL- a Randomized Clinical Trial

Conditions
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Social Anxiety Disorder, Agoraphobia

Intervention / Treatment
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* Behavioral: CBT with virtual reality exposure therapy
* Behavioral: CBT in vivo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfilling diagnostic criteria for social anxiety disorder (ICD-code: F40.1) and/or Agoraphobia (ICD-code: 40.0) Age 18-75 years Sufficient knowledge of the Danish language Informed consent Exclusion Criteria: Alcohol or drug dependence (ICD-code: F10-19.20-26).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT in virtuo<br>Receives CBT in group format with Virtual Reality Exposure Therapy | Behavioral: CBT with virtual reality exposure therapy<br>* The patients receiving the in virtuo exposure will be immersed using an Oculus Go head-mounted display, enabling viewing of 360° spherically camera recorded VR environments. The VR scenarios will thus be high-resolution 360° stereoscopic films, that are played around the viewer. For ease of use, the individual videos will be administered from an app that has been designed to be as intuitive to operate as possible. The patient will only have to put on the headset, adjust the focus and choose the desired environment by looking at it in the app. 360° video was chosen because it gives the most photorealistic visuals, while also being the cheapest to produce. The downside is that it does not allow direct user-interaction (e.g. the viewer cannot affect the environment in any way). To circumvent this, there are multiple junctions throughout the films where the actors will talk directly and unsolicited to the viewer while also allowing time for the viewer to respond.<br>|
| Active Comparator: CBT in vivo<br>Active comparator, receives CBT in group format. Treatment as usual. | Behavioral: CBT in vivo<br>* The therapeutic intervention is manual-based cognitive-behavioral CBT group therapy adapted from the approach of Turk, Heimberg & Magee and Graske & Barlow with worksheets from Arendt & Rosenberg and inspiration from Bouchard et al. The treatment will consist of 14 weekly two-hour group sessions following the manual to ensure equal and uniform treatment for every patient throughout the study. Concurrent psychopharmacological treatment is allowed in both intervention arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptom severity of primary diagnosis | Total scores on the Liebowitz Social Anxiety Scale (LSAS) for patients with social anxiety disorder and the Mobility Inventory for Agoraphobia (MIA) for patients with Agoraphobia measured pre-treatment, post-treatment and at one-year follow-up converted to the 'Percentage of Maximum Possible Score' (POMP) and averaged within treatment arms. POMP calculations can bring differently measured items to the same metric and do not change the multivariate distribution and covariance matrix of the transformed variables. Ranges from 0 to 100. Higher is worse. | Between 30 to 1 day(s) before treatment, between 0 and 14 days after treatment ends and between 365 to 395 days after first assesment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Depression Rating Scale, 6 item score | Measures symptoms of depression for the last 3 days.Total score will be measured. Ranges from 0 to 22. Higher is worse. | Between 30 to 1 day(s) before treatment, between 0 and 14 days after treatment ends and between 365 to 395 days after first assesment. | 
| Change in Brief Version of the Fear of Negative Evaluation Scale score | Self-report, total score is measured, ranging from 12 to 60. Higher is worse. | Between 30 to 1 day(s) before treatment, between 0 and 14 days after treatment ends and between 365 to 395 days after first assesment. | 
| Change in Work and Social Adjustment Scale score | Self-report. Total score is measured, ranging from 0 to 40. Higher is better. | Between 30 to 1 day(s) before treatment, between 0 and 14 days after treatment ends and between 365 to 395 days after first assesment. | 
| Client Satisfaction Questionnaire | Measures satisfaction with treatment. Total score is measured, ranging from 8 to 32. Higher is better. Self-report. | Measured between 0 and 14 days after treatment ends | 
| Change in WHO Well-Being Index 5 items, score | Measures overall quality of life. Total score is measured. Ranges from 0 to 25. Higher is better. Self-report. | Between 30 to 1 day(s) before treatment, between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment. | 
| Treatment response on social anxiety disorder symptoms | Liebowitz Social Anxiety Scale total score below 50 or a 15 points drop. Ranges from 0 to 144. Higher is worse. | Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment. | 
| Treatment response on agoraphobia symptoms | Mobility Inventory for Agoraphobia total score below 2 or a 0.5 points drop Ranges from 0 to 5. Higher is worse. | Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment. | 
| Remission from social anxiety disorder | Liebowitz Social Anxiety Scale total score below 25 and not qualifying for social anxiety disorder as measured using the MINI-7. Ranges from 0 to 144. Higher is worse. | Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment. | 
| Remission from agoraphobia | MIA total score below 1.5 and not qualifying for agoraphobia as measured using the MINI-7. Ranges from 0 to 5. Higher is worse. | Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social anxiety, Virtual Reality, Virtual Reality Exposure Therapy, RCT, Social Phobia, Agoraphobia