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

Social Anxiety Disorder Clinical Trial

— SoREAL  

Official title:

SoREAL- a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03845101
• Other study ID #: NNF17OC0027780
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: April 9, 2024

Study information

• Verified date: March 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Benjamin Arnfred
• Phone: 21630878
• Email: benjamin.alexander.thorup.arnfred[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: April 9, 2024
• Est. primary completion date: April 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Ambulatorium for Angst og Tvangssygdomme	Aalborg
Denmark	Psykoterapeutisk Ambulatorium	Brøndby	Copenhagen
Denmark	Psykoterapeutisk Klinik, Nannasgade	Copenhagen	Captial Region Of Denmark
Denmark	Psykoterapeutisk klinik, Frederiksberg	Frederiksberg	Copenhagen
Denmark	Psykoterapeutisk Center Stolpegård	Gentofte	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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.

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.

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

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Personal and Social Performance Scale score	Measured as total score. Ranges from 0 to 100. 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.
Other	Change in Alchohol and drug (legal and illegal) use	Measured using the Time Line Follow Back interview, in which you systematically go through every day for the last 4 weeks recording any alcohol and drug (legal and illegal) consumption. Will be scored in units of 12 grams of alcohol and in grams of substance consumed. Less consumed alchohol and substance will be considered better.	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	Change in General Self Efficacy Scale Score	Measures general belief in ones own capabilities. Self-report. Total score is measured. Ranges from 10 to 40. Higher is better.	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	Working Alliance Inventory	Measured the experience of alliance between the client and the therapist(s). Self-report. Total score is measured. Ranges from 12 to 60. Higher score is better.	Measured between 0 and 14 days after treatment ends.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.