Clinical trial NCT03845101: CBT Versus CBT With Virtual Reality Exposure for Social Anxiety Disorder and Agoraphobia
Official title: SoREAL- a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Anxiety Disorder
Agoraphobia
Keywords: Social anxiety
Virtual Reality
Virtual Reality Exposure Therapy
RCT
Social Phobia
Agoraphobia
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in symptom severity of primary diagnosis
timeFrame: 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:
measure: Change in Hamilton Depression Rating Scale, 6 item score
timeFrame: 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.
measure: Change in Brief Version of the Fear of Negative Evaluation Scale score
timeFrame: 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.
measure: Change in Work and Social Adjustment Scale score
timeFrame: 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.
measure: Client Satisfaction Questionnaire
timeFrame: Measured between 0 and 14 days after treatment ends
measure: Change in WHO Well-Being Index 5 items, score
timeFrame: 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.
measure: Treatment response on social anxiety disorder symptoms
timeFrame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
measure: Treatment response on agoraphobia symptoms
timeFrame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
measure: Remission from social anxiety disorder
timeFrame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
measure: Remission from agoraphobia
timeFrame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
Other outcomes:
measure: Change in Personal and Social Performance Scale score
timeFrame: 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.
measure: Change in Alchohol and drug (legal and illegal) use
timeFrame: 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.
measure: Change in General Self Efficacy Scale Score
timeFrame: 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.
measure: Working Alliance Inventory
timeFrame: Measured between 0 and 14 days after treatment ends.
Locations:
city: Copenhagen
country: Denmark
facility: Psykoterapeutisk Klinik, Nannasgade
state: Captial Region Of Denmark
city: Brøndby
country: Denmark
facility: Psykoterapeutisk Ambulatorium
state: Copenhagen
city: Frederiksberg
country: Denmark
facility: Psykoterapeutisk klinik, Frederiksberg
state: Copenhagen
city: Gentofte
country: Denmark
facility: Psykoterapeutisk Center Stolpegård
state: Copenhagen
city: Aalborg
country: Denmark
facility: Ambulatorium for Angst og Tvangssygdomme
Study officials:
affiliation: Mental Health Centre Copenhagen (CORE)
name: Merete Nordentoft
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Rosenberg NK, Mørck MM, Arendt M. Kognitiv terapi. Nyeste udvikling. Kogn Ter Nyeste Udvikl. 2012.
citation: 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.
citation: 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.