Social Anxiety Disorder Clinical Trial
— SoREALOfficial title:
SoREAL- a Randomized Clinical Trial
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.
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
Mental Health Services in the Capital Region, Denmark |
Denmark,
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.
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. |
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 |