An interventional study of CBT with virtual reality exposure therapy and CBT in vivo in Social Anxiety Disorder and Agoraphobia, sponsored by Mental Health Services in the Capital Region, Denmark. Status unknown at 5 sites in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Mental Health Services in the Capital Region, Denmark · Not applicable, Interventional, and Treatment
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.
367 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.
This study's planned enrollment of 302 is above the median of 76 across 338 interventional studies indexed under Phobia, Social.
Browse Phobia, Social studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 49 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives CBT in group format with Virtual Reality Exposure Therapy
Behavioral: CBT with virtual reality exposure therapy
Active comparator, receives CBT in group format. Treatment as usual.
Behavioral: CBT in vivo
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.
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.
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.
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.
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.
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.
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.
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.
Change in Work and Social Adjustment Scale score
Self-report. Total score is measured, ranging from 0 to 40. Higher is better.
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.
Client Satisfaction Questionnaire
Measures satisfaction with treatment. Total score is measured, ranging from 8 to 32. Higher is better. Self-report.
Time frame: Measured between 0 and 14 days after treatment ends
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.
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.
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.
Time frame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
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.
Time frame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
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.
Time frame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
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.
Time frame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
Change in Personal and Social Performance Scale score
Measured as total score. Ranges from 0 to 100. Higher is better. Self-report.
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.
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.
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.
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.
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.
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.
Time frame: Measured between 0 and 14 days after treatment ends.
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Started Feb 2019 (actual). Primary completion is estimated for Apr 2024, 61 months after the start.
Of 142 non-industry interventional studies with no phase under Phobia, Social, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's planned 61 months is above that.
Counting every sponsor, half of 148 studies reached it within 28 months; a quarter within 14 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Mental Health Services in the Capital Region, Denmark