Self-guided virtual reality therapy for social anxiety disorder
| ISRCTN | ISRCTN18013983 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18013983 |
- Submission date
- 31/01/2022
- Registration date
- 02/02/2022
- Last edited
- 30/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Social anxiety disorder (SAD), also called social phobia, is a long-term and overwhelming fear of social situations. Cognitive behavior therapy (CBT) is therapy that helps you identify negative thought patterns and behaviours, and change them. CBT is the first-line treatment for SAD, yet its accessibility is often constrained with long waiting times. Digital therapeutic applications, including psychoeducation and self-guided behavioral experiments in virtual reality (VR), could facilitate access and reduce waiting times. Psychoeducation involves learning about and understanding mental health and wellbeing. The study aims to investigate if self-guided digital therapeutic applications, offering ultra-short-time therapy combined with VR components, can reduce the severity of SAD.
Who can participate?
Patients with Social Anxiety Disorder as a primary disorder.
What does the study involve?
Participants take part in a brief diagnostic process containing a phone screening and two therapeutic appointments. If a social anxiety disorder is diagnosed, participants are randomized into an experimental or a control group. Participants in the experimental group receive a prescription for a therapeutic application. After six weeks, in which they must complete psychoeducation, they meet with a therapist, and the virtual reality exposition is activated. After four weeks, participants have a final appointment to reflect on their experience. At each appointment and on a six-week follow-up, questionnaires are filled in. The control group also has an equal amount of appointments with a therapist but does not get a prescription for the therapeutic application until the fifth appointment (six-week follow up).
What are the possible benefits and risks of participating?
A possible benefit is that the application-based therapy may help to reduce participants’ anxiety. Including VR in therapy could relieve therapists and help reduce the waiting time for patients. The results of this study can have a great impact on therapeutic interventions and inform future research on VR in therapy. There are no significant risks of participating in the study.
Where is the study run from?
University of Siegen (Germany)
When is the study starting and how long is it expected to run for?
April 2021 to January 2024
Who is funding the study?
DFG-Graduiertenkolleg 2493 “Folgen Sozialer Hilfen” (https://folgensozialerhilfen.de/) (Germany)
Who is the main contact?
Anne Sophie Hildebrand, anne.hildebrand@uni-siegen.de
Contact information
Scientific
DFG-Research Training Group 2493
Hölderlinstr. 3
Siegen
57076
Germany
 ORCID ID |
0000-0002-5612-4083 |
|---|---|
| Phone | +49(0) 271-740-3688 |
| anne.hildebrand@uni-siegen.de |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact information to request a participant information sheet |
| Scientific title | Self-guided virtual reality therapy for social anxiety disorder: a study protocol for a randomized controlled trial |
| Study hypothesis | We expect that patients who receive application-based treatment will show less symptoms of social anxiety at an interim, a post, and a 6-weeks follow-up assessment, compared to the control group. To test a clinically relevant change, the remission rates of patients between both groups will be compared at the follow-up assessment. |
| Ethics approval(s) | Approved 08/11/2019, Ethics Committee of the University of Siegen (Jonas Kameboge, Adolf-Reichwein-Str. 2a, NA, 57076, Germany; +490271 740-4819; ethikrat@uni-siegen.de), ref: ER_84_2021 |
| Condition | Self-guided treatment for patients with social anxiety disorder |
| Intervention | The study is a single-center randomized controlled trial. Relative changes in SAD symptoms (interim vs. baseline, post vs. baseline, follow-up vs. baseline) will be compared between a group receiving a digital (VR) application and a control group will be compared in a superiority design. The study employs a 2 (condition: application-based vs. control treatment) x 4 (time: baseline assessment, interim assessment, post assessment, and 6-weeks-follow-up) design. Participants will be randomly assigned to the experimental (EG) or control group (CG), according to an externally constructed randomization plan. EG: Four meetings with a therapist + psychoeducation and virtual reality exposition via the application Invirto CG: Four meetings with a therapist |
| Intervention type | Behavioural |
| Primary outcome measure | Questionnaire on social anxiety and social competence deficits (SASKO) measured on the second, third and fourth appointment |
| Secondary outcome measures | Remission, measured via Mini-DIPS at the baseline and follow-up assessment |
| Overall study start date | 11/04/2021 |
| Overall study end date | 01/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 181 |
| Participant inclusion criteria | Social anxiety disorder (F40.1) |
| Participant exclusion criteria | 1. Stroke or coronary in the past 2. Angina pectoris 3. Cardiac arrhythmias 4. Hypertension 5. Asthma or a chronic obstructive pulmonary disease (COPD) 6. Pregnancy or the suspicion 7. Strong visual disorders 8. Epilepsy or seizures in the past 9. Psychological disorders with organic cause (for example dementia) 10. Vertigo 11. Vestibular impairments 12. Psychological or behavioral disorders because of the consumption of psychoactive substances 13. Schizophrenia, schizotypal or delusional disorders 14. Severe depression or mania 15. Acute suicidal tendencies or lack of capability to negotiate a no-suicide agreement 16. Not yet in therapy |
| Recruitment start date | 01/03/2022 |
| Recruitment end date | 01/01/2024 |
Locations
Countries of recruitment
- Germany
Study participating centre
Siegen
57076
Germany
Sponsor information
University/education
Adolf-Reichwein-Straße 2
Siegen
57076
Germany
| Phone | +49 2717400 |
|---|---|
| presse@uni-siegen.de | |
| Website | https://www.uni-siegen.de/start/ |
"ROR" |
https://ror.org/02azyry73 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Results and Publications
| Intention to publish date | 10/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the study protocol in Trials Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The dataset will be available upon request from the corresponding author (Anne Sophie Hildebrand, anne.hildebrand@uni-siegen.de). The data will be available after the overall trial end. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 12/05/2022 | 16/05/2022 | Yes | No | |
| Dataset | 21/08/2024 | No | No |
Additional files
Editorial Notes
21/08/2024: Dataset added.
16/05/2022: Publication reference added.
01/02/2022: Trial's existence confirmed by Ethics Committee of the University of Siegen
