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NCT05302518: VR8
Virtual Reality for AnxIety Disorders - Randomized Controlled Trial
NA trial testing Cognitive behavioral therapy with exposure in virtual reality in Social Anxiety in 80 participants. Completed in 4 January 2025.
4 January 2025
Quick facts
| Lead sponsor | Region of Southern Denmark |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 31 March 2022 |
| Primary completion | 4 January 2025 |
| Estimated completion | 4 January 2025 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Cognitive behavioral therapy with exposure in virtual reality
- Cognitive behavioral therapy with exposure in vivo
Conditions studied
- Social Anxiety — all drugs for Social Anxiety →
- Social Phobia — all drugs for Social Phobia →
Sponsor
Region of Southern Denmark
Who can join
Adults 18 to 75, any sex, with Social Anxiety or Social Phobia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Social anxiety disorder (SAD) has a high prevalence and an early onset and has a lengthy recovery period often taking decades to occur. Current evidence supports the efficacy of cognitive behavioral therapy (CBT) with virtual reality (VR) exposure. However, the evidence is based on a small number of studies. This trial examines the efficacy of an intervention that combines CBT with individually tailored exposure in VR. During exposure, participants' anxiety level is estimated in real time based on heart rate and electrodermal activity. Estimated anxiety level can guide the therapist's adjustment of the VR content. The above treatment is compared with the gold standard treatment for SAD which is cognitive behavioral therapy with exposure conducted in real life. Treatment is individual, manual-based and consists of 10 weekly sessions with a duration of 60 minutes. The aim of the study is to investigate whether CBT combined with exposure in VR (adapted on the basis of estimated anxiety level) is more effective than CBT with exposure in real life. The trial is a randomized controlled trail (RCT). The study includes 90 participants diagnosed with SAD. Assessments are carried out pre-treatment, mid-treatment and at follow-up (6 and 12 months). The primary outcome of the study is self-reported symptoms of social anxiety using Social Interaction Anxiety Scale. The primary endpoint is post-treatment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Cognitive behavioral therapy with adaptive virtual reality exposure vs. cognitive behavioral therapy with <i>in vivo</i> exposure in the treatment of social anxiety disorder: A study protocol for a randomized controlled trial.
Ørskov PT, Lichtenstein MB, Ernst MT, Fasterholdt I, et al · · 2022 · cited 5× · PMID 36299540 · DOI 10.3389/fpsyt.2022.991755
Verify or expand the search:
- PubMed search for NCT05302518
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Social Anxiety
Currently open trials in the same condition.
- NCT06934525 — Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings · NA · recruiting
- NCT07259005 — Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety · NA · recruiting
- NCT06465589 — Variations of Anonymity, Transparency, and Efficacy in Digital Health Applications · NA · active not recruiting
- NCT06409247 — iExposure Intervention for Social Anxiety · NA · active not recruiting
- NCT06564402 — Augmentation of Exposure Using Positive Mental Rehearsal in Individuals With Increased Social Anxiety · NA · recruiting
Other Region of Southern Denmark trials
Trials by the same sponsor.
- NCT06655623 — A Multiple Case Study of Schema Therapy for Difficult-to-treat Depression- DEPRE-ST*Case · NA · completed
- NCT05833087 — Schema Therapy for Patients With Chronic Treatment Resistant Depression · NA · recruiting
- NCT04610749 — Diabetic Retinopathy as a Marker of Cognitive Dysfunction and Depression · completed
- NCT04398797 — Prevention of AcuTe admIssioN Algorithm (PATINA) · NA · completed
- NCT03973541 — CBT With VR Based Exposure for Social Anxiety Disorder · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05302518 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Region of Southern Denmark
- Last refreshed: 5 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05302518.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing