A pilot study of virtual reality exposure therapy that alternates calming and mildly stressful scenarios for adults with anxiety
| ISRCTN | ISRCTN92638354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92638354 |
| Sponsor | York University |
| Funder | Univerzita Karlova v Praze |
- Submission date
- 13/01/2026
- Registration date
- 13/01/2026
- Last edited
- 13/01/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
According to the Contrast Avoidance Model (CAM), people with Generalized Anxiety Disorder (GAD) may maintain worry to avoid sudden emotional shifts from calm to distress and may benefit from exposure to such emotional contrasts. This study explores whether virtual reality (VR) sessions that alternate between calming and mildly anxiety-inducing scenarios could support this approach in people with GAD.
Who can participate?
Adults (18+) with a prior clinical diagnosis of GAD and moderate anxiety symptoms.
What does the study involve?
Three in-person VR sessions (approximately 1 hour each) over 3 weeks, plus online questionnaires at baseline and 1-month follow-up. During sessions, participants wear a VR headset and heart rate monitor while experiencing calming and anxiety-inducing scenarios.
What are the possible benefits and risks of participating?
Participants may gain insight into their emotional responses and practice relaxation techniques. Risks include temporary anxiety during scenarios and possible VR-related discomfort (e.g., dizziness), which are minimized through continuous monitoring and in-VR guided relaxation segments.
Where is the study run from?
York University, Toronto, Canada
When is the study starting and how long is it expected to run for?
February 2026 to August 2026
Who is funding the study?
Charles University Doctoral Scholarship Program
Who is the main contact?
Mgr. Barbora Darmova, Charles University
Contact information
Public, Scientific
Pricna 1892/4
Prague
11000
Czech Republic
 ORCID ID |
0000-0002-6809-9583 |
|---|---|
| Phone | +420732121003 |
| info@vresearch.org |
Principal investigator
Stong College, Room 346
165 Campus Walk
York University (Keele Campus)
Toronto ON
M3J 1P3
Canada
| ORCID ID |
0000-0002-7176-7191 |
|---|---|
| Phone | +16475046537 |
| lora.appel@yorku.ca |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Treatment | |
| Scientific title | Feasibility and preliminary efficacy of virtual reality emotional contrast exposure therapy for adults with Generalized Anxiety Disorder: a single-arm pilot study | |
| Study objectives | 1. To assess feasibility (recruitment and retention, delivery of the intervention as planned, and acceptability) of a Contrast Avoidance Model-based virtual reality exposure intervention for adults with generalized anxiety disorder. 2. To estimate preliminary changes in anxiety symptoms and distress from baseline to post-intervention and 1-month follow-up. 3. To characterize autonomic reactivity during the alternating relaxation and anxiety-inducing virtual reality segments across the intervention. | |
| Ethics approval(s) |
Approved 30/07/2025, Human Participants Review Committee (HPRC), Office of Research Ethics (ORE), York University (Kaneff Tower, 4700 Keele Street, Toronto ON, M3J 1P3, Canada; +1 416-736-2100; ore@yorku.ca), ref: e2025-225 | |
| Health condition(s) or problem(s) studied | Generalized Anxiety Disorder (GAD) with moderate-to-severe anxiety symptoms. | |
| Intervention | Participants will receive a single-arm virtual reality emotional-contrast exposure intervention delivered in person over three visits (~45–60 minutes each), scheduled approximately one week apart. Each visit will follow a fixed structure of alternating guided relaxation segments and mild anxiety-inducing virtual reality scenarios, ending with a final relaxation segment. Five distinct anxiety-inducing scenarios will be used; each scenario will last 2 minutes and relaxation segments will last ~3–5 minutes. The order of the anxiety-inducing scenarios will be counterbalanced across participants using a Latin square. No control intervention will be used and participants will not be randomized to study arms. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 01/08/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 15 |
| Key inclusion criteria | 1. Age 18 years or older. 2. Prior clinical diagnosis of generalized anxiety disorder (self-reported). 3. Meets the study’s screening threshold for at least moderate anxiety (GAD-7 ≥ 10). 4. Able to provide informed consent in English. 5. Able and willing to complete all study procedures, including three in-person VR visits and the 1-month follow-up assessment. |
| Key exclusion criteria | 1. History of epilepsy or other photosensitive seizure disorder. 2. Severe motion sickness or vestibular disorder likely to be triggered by virtual reality. 3. Severe uncontrolled medical condition that could increase risk during induced anxiety (e.g., serious heart problems). 4. Severe psychiatric comorbidity that could increase risk during induced anxiety (e.g., active psychosis). 5. Pregnancy (excluded as a precaution). |
| Date of first enrolment | 01/02/2026 |
| Date of final enrolment | 01/07/2026 |
Locations
Countries of recruitment
- Canada
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
13/01/2026: Study’s existence confirmed by the Office of Research Ethics, York University, Canada.
