Social Anxiety DisorderSoREALNCT03845101
CBT Versus CBT With Virtual Reality Exposure for Social Anxiety Disorder and Agoraphobia
A study testing CBT with virtual reality exposure therapy and CBT in vivo in people with Social Anxiety Disorder and Agoraphobia, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 5 sites in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Social Anxiety Disorder, Agoraphobia
- What is being tested?
- CBT with virtual reality exposure therapy and CBT in vivo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 5 sitesDenmark
- Study dates
- 19 Feb 2019to 9 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Alcohol or drug dependence (ICD-code: F10-19.20-26).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Ambulatorium for Angst og Tvangssygdomme
Aalborg, 9000
Benjamin Arnfred, 21630878 ext. +45, barn0006@regionh.dk
- Recruiting
Psykoterapeutisk Ambulatorium
Brøndby, Copenhagen, 2605
Benjamin Arnfred, 21 63 08 78 ext. +45, barn0006@regionh.dk
- Recruiting
Psykoterapeutisk Klinik, Nannasgade
Copenhagen, Captial Region of Denmark, 2200
Benjamin Arnfred, 45 21 63 08 78, benjamin.alexander.thorup.arnfred@regionh.dk
- Recruiting
Psykoterapeutisk klinik, Frederiksberg
Frederiksberg, Copenhagen, 2000
Benjamin Arnfred, 21630878 ext. +45, barn0006@regionh.dk
- Recruiting
Psykoterapeutisk Center Stolpegård
Gentofte Municipality, Copenhagen, 2820
Benjamin Arnfred, 31724603, benjamin.ata@gmail.com
About this study
Official 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.
Read more
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.
- Conditions
- Social Anxiety Disorder, Agoraphobia
- Being tested
- CBT with virtual reality exposure therapy, CBT in vivo
- Keywords
- Social anxiety, Virtual Reality, Virtual Reality Exposure Therapy, RCT, Social Phobia, Agoraphobia
- Medical subject headings
- Phobia, Social, Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT with virtual reality exposure therapyBehavioural
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 vivoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT in virtuo | Experimental | Receives CBT in group format with Virtual Reality Exposure Therapy Receives: Behavioral: CBT with virtual reality exposure therapy |
| CBT in vivo | Active comparator | Active comparator, receives CBT in group format. Treatment as usual. Receives: Behavioral: CBT in vivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start19 Feb 2019
- Primary completion9 Apr 2024 (estimated)
- Study completion9 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merete Nordentoft, Principal investigator, Mental Health Centre Copenhagen (CORE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845101
- Sponsor's protocol ID
- NNF17OC0027780
- Acronym
- SoREAL
- Status last verified
- Mar 2023
- First submitted
- 21 Jan 2019
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
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.
PubMed 35110313
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SoREAL- a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03845101
- Acronym / sponsor ID
- SoREAL / NNF17OC0027780
- Conditions
- Social Anxiety Disorder, Agoraphobia
- Keywords
- Social anxiety, Virtual Reality, Virtual Reality Exposure Therapy, RCT, Social Phobia, Agoraphobia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 9 Apr 2024 (estimated)
- Study completion
- 9 Apr 2024 (estimated)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT in virtuo | Experimental | Behavioral: CBT with virtual reality exposure therapyReceives CBT in group format with Virtual Reality Exposure Therapy |
| CBT in vivo | Active comparator | Behavioral: CBT in vivoActive comparator, receives CBT in group format. Treatment as usual. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Alcohol or drug dependence (ICD-code: F10-19.20-26).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT with virtual reality exposure therapyThe 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. | Behavioural | CBT in virtuo |
| CBT in vivoThe 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. | Behavioural | CBT in vivo |
Primary outcome
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.
9 secondary outcomes
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.
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.
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.
Client Satisfaction Questionnaire
Time frame: Measured between 0 and 14 days after treatment ends
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.
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.
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.
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.
Remission from agoraphobia
Time frame: Between 0 and 14 day(s) after treatment ends and between 365 to 395 days after first assesment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- BackgroundTurk 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.
- BackgroundGraske 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.
- BackgroundRosenberg NK, Mørck MM, Arendt M. Kognitiv terapi. Nyeste udvikling. Kogn Ter Nyeste Udvikl. 2012.
- BackgroundBouchard 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.
- Derived from this study: PubMed 35110313Arnfred 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Nordentoft principal investigator
Mental Health Centre Copenhagen (CORE)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT with virtual reality exposure therapy and CBT in vivo in people with Social Anxiety Disorder and Agoraphobia, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Arnfred (21630878 ext. +45, benjamin.alexander.thorup.arnfred@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845101, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.