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

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ClinicalTrials.gov Identifier: NCT03845101
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

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.


Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Agoraphobia Behavioral: CBT with virtual reality exposure therapy Behavioral: CBT in vivo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SoREAL- a Randomized Clinical Trial
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : April 9, 2023
Estimated Study Completion Date : April 9, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: CBT in virtuo
Receives CBT in group format with Virtual Reality Exposure Therapy
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.

Active Comparator: CBT in vivo
Active comparator, receives CBT in group format. Treatment as usual.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in symptom severity of primary diagnosis [ Time Frame: 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. ]

    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.



Secondary Outcome Measures :
  1. Change in Hamilton Depression Rating Scale, 6 item score [ Time Frame: 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. ]
    Measures symptoms of depression for the last 3 days.Total score will be measured. Ranges from 0 to 22. Higher is worse.

  2. Change in Brief Version of the Fear of Negative Evaluation Scale score [ Time Frame: 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. ]
    Self-report, total score is measured, ranging from 12 to 60. Higher is worse.

  3. Change in Work and Social Adjustment Scale score [ Time Frame: 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. ]
    Self-report. Total score is measured, ranging from 0 to 40. Higher is better.

  4. Client Satisfaction Questionnaire [ Time Frame: Measured between 0 and 14 days after treatment ends ]
    Measures satisfaction with treatment. Total score is measured, ranging from 8 to 32. Higher is better. Self-report.

  5. Change in WHO Well-Being Index 5 items, score [ Time Frame: 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. ]
    Measures overall quality of life. Total score is measured. Ranges from 0 to 25. Higher is better. Self-report.

  6. Treatment response on social anxiety disorder symptoms [ Time Frame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment. ]

    Liebowitz Social Anxiety Scale total score below 50 or a 15 points drop.

    Ranges from 0 to 144. Higher is worse.


  7. Treatment response on agoraphobia symptoms [ Time Frame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment. ]

    Mobility Inventory for Agoraphobia total score below 2 or a 0.5 points drop

    Ranges from 0 to 5. Higher is worse.


  8. Remission from social anxiety disorder [ Time Frame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment. ]

    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.


  9. Remission from agoraphobia [ Time Frame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment. ]

    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.



Other Outcome Measures:
  1. Change in Personal and Social Performance Scale score [ Time Frame: 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. ]
    Measured as total score. Ranges from 0 to 100. Higher is better. Self-report.

  2. Change in Alchohol and drug (legal and illegal) use [ Time Frame: 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. ]
    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.

  3. Change in General Self Efficacy Scale Score [ Time Frame: 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. ]
    Measures general belief in ones own capabilities. Self-report. Total score is measured. Ranges from 10 to 40. Higher is better.

  4. Working Alliance Inventory [ Time Frame: Measured between 0 and 14 days after treatment ends. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845101


Contacts
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Contact: Benjamin Arnfred 21630878 ext +45 benjamin.alexander.thorup.arnfred@regionh.dk

Locations
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Denmark
Psykoterapeutisk Klinik, Nannasgade Recruiting
Copenhagen, Captial Region Of Denmark, Denmark, 2200
Contact: Benjamin Arnfred    45 21 63 08 78    benjamin.alexander.thorup.arnfred@regionh.dk   
Psykoterapeutisk Ambulatorium Recruiting
Brøndby, Copenhagen, Denmark, 2605
Contact: Benjamin Arnfred    21 63 08 78 ext +45    barn0006@regionh.dk   
Psykoterapeutisk klinik, Frederiksberg Recruiting
Frederiksberg, Copenhagen, Denmark, 2000
Contact: Benjamin Arnfred    21630878 ext +45    barn0006@regionh.dk   
Psykoterapeutisk Center Stolpegård Recruiting
Gentofte, Copenhagen, Denmark, 2820
Contact: Benjamin Arnfred    31724603    benjamin.ata@gmail.com   
Ambulatorium for Angst og Tvangssygdomme Recruiting
Aalborg, Denmark, 9000
Contact: Benjamin Arnfred    21630878 ext +45    barn0006@regionh.dk   
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Investigators
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Principal Investigator: Merete Nordentoft Mental Health Centre Copenhagen (CORE)
Publications:
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.
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.
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.

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Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT03845101    
Other Study ID Numbers: NNF17OC0027780
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completed analyses and publication, all depersonalised individual patient data will be transferred to The Danish National Archives and made available for other researchers upon reasonable request and with permission of The Danish National Archives.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mental Health Services in the Capital Region, Denmark:
Social anxiety
Virtual Reality
Virtual Reality Exposure Therapy
RCT
Social Phobia
Agoraphobia
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Agoraphobia
Mental Disorders
Phobic Disorders