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

NCT03845101 | Unknown DMC

• 1 other identifier: NNF17OC0027780
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 5

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

Keywords

Social anxiety; Virtual Reality; Virtual Reality Exposure Therapy; RCT; Social Phobia; Agoraphobia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Hamilton Depression Rating Scale, 6 item score

  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

  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

  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

  Measured between 0 and 14 days after treatment ends

• Change in WHO Well-Being Index 5 items, score

  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.

Other Outcomes (4)

• Change in Personal and Social Performance Scale score

  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.

• Change in Alchohol and drug (legal and illegal) use

  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.

• Change in General Self Efficacy Scale Score

  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.

Study Arms (2)

CBT in virtuo

EXPERIMENTAL

Receives CBT in group format with Virtual Reality Exposure Therapy

Behavioral: CBT with virtual reality exposure therapy

CBT in vivo

ACTIVE COMPARATOR

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

Behavioral: CBT in vivo

Interventions

CBT with virtual reality exposure therapy 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 virtuo

CBT in vivo 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.

CBT in vivo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Alcohol or drug dependence (ICD-code: F10-19.20-26).

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (5)

Psykoterapeutisk Klinik, Nannasgade

Copenhagen, Captial Region of Denmark, 2200, Denmark

RECRUITING

Psykoterapeutisk Ambulatorium

Brøndby, Copenhagen, 2605, Denmark

RECRUITING

Psykoterapeutisk klinik, Frederiksberg

Frederiksberg, Copenhagen, 2000, Denmark

RECRUITING

Psykoterapeutisk Center Stolpegård

Gentofte Municipality, Copenhagen, 2820, Denmark

RECRUITING

Ambulatorium for Angst og Tvangssygdomme

Aalborg, 9000, Denmark

RECRUITING

Related Publications (5)

• 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.

  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.

  BACKGROUND

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

  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.

  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.

  PMID: 35110313 DERIVED

MeSH Terms

Conditions

Phobia, Social; Agoraphobia

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Merete Nordentoft

  Mental Health Centre Copenhagen (CORE)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Arnfred

CONTACT

21630878; benjamin.alexander.thorup.arnfred@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 19, 2019
• Study Start: February 19, 2019
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The current policy of The Danish National Archives is to keep data stored securely indefinitely. Data will be transfered The Danish National Archives after completed analyses and publication. However, this can take a maximum of 10 years, after which data must be refered to the National Archives.
• Access Criteria: Reasonable request and permission of The Danish National Archives.

Locations

DK (5)