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

NCT ID: NCT03845101

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-19
• Study Completion Date: 2024-04-09

Brief 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.

Conditions

Social Anxiety Disorder; Agoraphobia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT in virtuo

Receives CBT in group format with Virtual Reality Exposure Therapy

Group Type: EXPERIMENTAL

CBT with virtual reality exposure therapy

Intervention Type: BEHAVIORAL

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.

CBT in vivo

Active comparator, receives CBT in group format. Treatment as usual.

Group Type: ACTIVE_COMPARATOR

CBT in vivo

Intervention Type: BEHAVIORAL

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.

Interventions

CBT with virtual reality exposure therapy

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.

Intervention Type: BEHAVIORAL

CBT in vivo

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merete Nordentoft

Role: PRINCIPAL_INVESTIGATOR

Mental Health Centre Copenhagen (CORE)

Locations

Psykoterapeutisk Klinik, Nannasgade

Copenhagen, Captial Region of Denmark, Denmark

Site Status: RECRUITING

Psykoterapeutisk Ambulatorium

Brøndby, Copenhagen, Denmark

Site Status: RECRUITING

Psykoterapeutisk klinik, Frederiksberg

Frederiksberg, Copenhagen, Denmark

Site Status: RECRUITING

Psykoterapeutisk Center Stolpegård

Gentofte Municipality, Copenhagen, Denmark

Site Status: RECRUITING

Ambulatorium for Angst og Tvangssygdomme

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Benjamin Arnfred

Role: CONTACT

benjamin.alexander.thorup.arnfred@regionh.dk

21630878 ext. +45

Facility Contacts

Benjamin Arnfred

Role: primary

benjamin.alexander.thorup.arnfred@regionh.dk

45 21 63 08 78

Benjamin Arnfred

Role: primary

barn0006@regionh.dk

21 63 08 78 ext. +45

Benjamin Arnfred

Role: primary

barn0006@regionh.dk

21630878 ext. +45

Benjamin Arnfred

Role: primary

benjamin.ata@gmail.com

31724603

Benjamin Arnfred

Role: primary

barn0006@regionh.dk

21630878 ext. +45

References

Turk CL, Heimberg RG, Magee L. Social anxiety disorder. In: Barlow DH, editor. Clin Handb Psychol Disord A step-by-step Treat Man. London: Guilford Press; 2008. p. 123-63.

Reference Type: BACKGROUND

Graske MG, Barlow DH. Panic Disorder and Agoraphobia. In: Barlow DH, editor. Clin Handb Psychol Disord. 4th ed. New York: The Guilford Press; 2008. p. 1-65.

Reference Type: BACKGROUND

Rosenberg NK, Mørck MM, Arendt M. Kognitiv terapi. Nyeste udvikling. Kogn Ter Nyeste Udvikl. 2012.

Reference Type: BACKGROUND

Bouchard S, Robillard G, Larouche S, Loranger C. Description of a treatment manual for in virtuo exposure with specific phobia. Virtual Real Psychol Med Pedagog Appl. 2012;81-108.

Reference Type: BACKGROUND

Arnfred B, Bang P, Hjorthoj C, Christensen CW, Stengaard Moeller K, Hvenegaard M, Agerskov L, Krog Gausboel U, Soe D, Wiborg P, Smith CIS, Rosenberg N, Nordentoft M. 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. BMJ Open. 2022 Feb 2;12(2):e051147. doi: 10.1136/bmjopen-2021-051147.

Reference Type: DERIVED

PMID: 35110313 (View on PubMed)

Other Identifiers

NNF17OC0027780

Identifier Type: -

Identifier Source: org_study_id