Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03845101
Other study ID # NNF17OC0027780
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06274112 - Using TMS to Understand Neural Processes of Social Motivation N/A
Completed NCT02554929 - Treatment of Social Anxiety Disorder and Selective Mutism N/A
Completed NCT00684541 - Interpretation Modification Program for Social Phobia N/A
Completed NCT00684320 - Attention Disengagement Training for Social Phobia N/A
Completed NCT03247075 - Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT N/A
Completed NCT02811458 - Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders N/A
Withdrawn NCT04622930 - Waitlist-Control Trial of Smartphone CBT for Social Anxiety Disorder (SAD) N/A
Active, not recruiting NCT05018312 - Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety N/A
Active, not recruiting NCT05124639 - Clinical Trial of a Group Self-management Support Program for Anxiety Disorders N/A
Completed NCT05858294 - The Safety, Acceptability and Efficacy of Alena N/A
Active, not recruiting NCT05600114 - Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder Phase 2
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Not yet recruiting NCT02924610 - Brief Intervention to Reduce Fear Phase 4
Active, not recruiting NCT02592564 - Brain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder N/A
Recruiting NCT02305537 - Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment N/A
Terminated NCT03764644 - Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders N/A
Unknown status NCT01712321 - Study of Vilazodone to Treat Social Anxiety Disorder N/A
Completed NCT01320800 - CBT for Social Anxiety Disorder Delivered by School Counselors Phase 2
Completed NCT00485615 - An Open Label Trial of Omega 3(o3mega+Joy)in the Treatment of Social Phobia Phase 2
Completed NCT00872820 - Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder N/A