Developing immersive virtual exposures for obsessive-compulsive disorder
| ISRCTN | ISRCTN13869986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13869986 |
| Contract | 5368451 |
| Sponsor | Champalimaud Foundation |
| Funder | Department for Science, Innovation and Technology |
- Submission date
- 23/12/2025
- Registration date
- 29/12/2025
- Last edited
- 29/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Obsessive–compulsive disorder (OCD) is a mental health condition that can cause distressing thoughts and repetitive behaviours. One of the most effective treatments for OCD is exposure and response prevention (ERP) therapy, which helps people gradually face their fears and tolerate discomfort. However, some people find it difficult to engage fully with exposure exercises and adhere to the therapeutic process, which hinders its efficacy. New technologies, such as virtual reality (VR) and artificial intelligence (AI), may help make exposure therapy more engaging and personalised.
This study aims to assess the feasibility, acceptability, and safety of a new artificial intelligence (AI)–generated exposure system for people with OCD. This study will explore emotional engagement with the exposure content when delivered via immersive virtual reality (VR) and via a screen-based format, as well as in comparison to neutral content.
Who can take part?
Adults aged 18–65 with a diagnosis of moderate to severe OCD who are receiving outpatient psychiatric care at the Champalimaud Clinical Centre.
What does the study involve?
Participants will be randomly allocated to one of three groups:
1. OCD-related exposure delivered in virtual reality
2. Neutral (non-threatening) virtual reality environments
3. OCD-related exposure delivered on a large screen
All participants will receive two standard ERP therapy sessions with a trained therapist. In addition, they will complete five short daily exposure sessions using their allocated technology, between the ERP sessions The exposure content is personalised for each participant and carefully reviewed by clinicians to ensure safety. Participants will be monitored throughout. Researchers will measure distress, physiological responses (such as heart rate and skin conductance), cybersickness, usability, and safety.
What are the possible benefits and risks?
Participants may benefit from taking part in structured exposure exercises and from contributing to research that could improve future OCD treatments. Temporary anxiety during exposure may occur as part of therapy. Clinicians will be present to ensure safety and provide support if needed.
Where is the study run from?
King's College London (UK) in collaboration with Champalimaud Foundation (Portugal).
Who is funding the study?
UK Department for Science, Innovation and Technology.
Who are the main contacts for this study?
1. Dr Mariana Pinto da Costa at King’s College London (Chief Investigator in the UK), mariana.pintodacosta@kcl.ac.uk
2. Dr Albino Oliveira Maia at Champalimaud Foundation (Principal Investigator in Portugal), albino.maia@research.fchampalimaud.org
Contact information
Public, Scientific, Principal investigator
16 De Crespigny Park
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0002-5966-5723 |
|---|---|
| Phone | +442078480002 |
| mariana.pintodacosta@kcl.ac.uk |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Developing immersive virtual exposures for obsessive-compulsive disorder – Protocol for a Randomised, Controlled, Proof-of-Concept Feasibility Trial | |
| Study acronym | DIVE-OCD | |
| Study objectives | To investigate if generative AI-driven virtual reality technology, delivered through VR headsets is feasible, acceptable and safe | |
| Ethics approval(s) |
Approved 07/10/2025, Champalimaud Foundation's Ethics Committee (Avenida de Brasília 66, Lisbon, 1200, Portugal; +351 210480200; ethics@research.fchampalimaud.org), ref: 07102025 | |
| Health condition(s) or problem(s) studied | Obsessive-Compulsive Disorder | |
| Intervention | 3 Arms: AI-generated OCD immersive VR exposure AI-generated OCD-related exposure via widescreen display Neutral immersive VR exposure (control) Arm 1: AI-generated OCD-related immersive VR exposure Participants receive OCD-related exposure content generated using a generative AI system and delivered via an immersive virtual reality headset. Exposure scenarios are personalised based on each participant’s individual OCD symptom profile and exposure hierarchy, and reviewed by a clinician prior to use. Participants complete five short daily VR exposure sessions under clinical supervision, in addition to standard ERP sessions. Arm 2: AI-generated OCD-related exposure delivered on a large screen Participants receive OCD-related exposure content generated using a generative AI system, reviewed by a clinician prior to use, and delivered via a large widescreen (non-immersive) display. Participants complete five short daily exposure sessions under clinical supervision, alongside standard ERP sessions. Arm 3: Neutral (non-threatening) immersive VR exposure Participants receive immersive VR exposure to neutral, non-threatening environments, without OCD-related content. Participants complete five short daily VR sessions, reviewed by a clinician prior to use, alongside standard ERP sessions. In the three arms, the total intervention duration is approximately 14 days. This includes the eligibility and assessment visit (Visit 1). This is followed by randomisation to one of the three study arms. One ERP session (Visit 2A, baseline) takes place 2 to 7 days after the assessment visit, followed by five technology-assisted exposure sessions (Visit 2B, Visit 3, Visit 4, Visit 5 and Visit 6), and one final ERP session (Visit 7A). This intervention sequence is identical across all study arms. Randomisation: Participants are randomly allocated (1:1:1) to one of three study arms. A stratified permuted block randomisation method with variable block sizes will be used to ensure unpredictability and allocation balance throughout the recruitment period. Allocation is concealed from outcome assessors. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Adults aged 18 to 65 years 2. Primary diagnosis of OCD confirmed by Mini International Neuropsychiatric Interview (MINI 5.0.0) 3. Y-BOCS-II score ≥ 14 (moderate to extremely severe symptoms) 4. At least one OCD subtype amenable to visual exposure (contamination/washing, checking, or symmetry/ordering) 5. Ability to provide informed consent |
| Key exclusion criteria | 1. Predominant OCD symptoms not suitable for visual exposure 2. Current or past psychotic episode, schizophrenia, or autism spectrum disorder 3. Current substance use disorder 4. Self-reported history of severe cardiovascular disease where acute physiological arousal poses a safety risk, defined as the presence of an implanted cardiac device (pacemaker or ICD), a diagnosis of heart failure or aortic aneurysm, or the occurrence of a major cardiac event (myocardial infarction, stroke, or cardiac surgery) within the past 12 months 5. Visual or auditory impairment, motion sickness susceptibility, or epilepsy |
| Date of first enrolment | 05/01/2026 |
| Date of final enrolment | 30/03/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
- Portugal
Study participating centres
London
SE5 8AB
England
Lisbon
1200
Portugal
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
24/12/2025: Study’s existence confirmed by the Department for Science, Innovation and Technology, UK.
