Group cognitive behavioural therapy with virtual reality exposure versus group cognitive behavioural therapy with in vivo exposure for social anxiety disorder and agoraphobia: a protocol for a randomised clinical trial
Feb 3, 2022BMJ open
Group cognitive behavioural therapy with virtual reality exposure versus real-life exposure for social anxiety and agoraphobia: a plan for a randomised clinical trial
A total of 302 patients with and/or will be enrolled in the SoREAL-trial.
The trial compares the effects of traditional cognitive behavioral therapy with .
Primary outcomes include diagnosis-specific symptoms measured using the Liebowitz Social Anxiety Scale and the Mobility Inventory for Agoraphobia.
Secondary outcomes to be assessed involve depression symptoms, social functioning, and patient satisfaction.
Exploratory outcomes may include substance and alcohol use, working alliance, and quality of life.
The trial is designed as a randomized, assessor-blinded, parallel-group clinical study.
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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 behavioural 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 behavioural therapy () versus group CBT with virtual reality exposure () for patients diagnosed with and/or , in mixed groups. CBT-in vivo CBT-in virtuo
METHODS AND ANALYSIS: The design is an investigator-initiated randomised, 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 centres of Copenhagen and North Sealand and the Northern Region of Denmark. All patients will be offered a manual-based 14-week cognitive behavioural group treatment programme, including eight sessions with exposure therapy. Therapy groups will be centrally randomised with concealed allocation sequence to eitheror. Patients will be assessed at baseline, post-treatment and 1-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. CBT-in virtuo CBT-in vivo
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. The trial has obtained approval by the Regional Ethics Committee of Zealand (H-6-2013-015) and the Danish Data Protection Agency (RHP-2014-009-02670). The trial is registered at ClinicalTrial.gov as NCT03845101. The patients will receive information on the trial both verbally and in written form. Written informed consent will be obtained from each patient before inclusion in the trial. The consent form will be scanned and stored in the database system and the physical copy will be destroyed. It is emphasised that participation in the trial is voluntary and that the patient can withdraw his or her consent at any time without consequences for further and continued treatment.
TRIAL REGISTRATION NUMBER: NCT03845101.
Key numbers
302
Total Participants
Patients diagnosed with and/or .
14 weeks
Treatment Duration
Length of the cognitive behavioural therapy program.
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