OCDNCT07857577
A Clinical Protocol for VR-Assisted CBT Targeting Quality of Life Outcomes for OCD
A study testing VR-CBT and G-VRET in people with OCD, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This study aims to evaluate the effectiveness of VR interventions in improving the psychological quality of life among OCD patients. Besides that, investigators also aim to examine the adverse effects of the virtual reality intervention on OCD patients and explore patients' perception on QOL changes following VR… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- OCD
- What is being tested?
- VR-CBT and G-VRET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Indicate interest to participate in the study,
- age 18 years and above
- able to commit to weekly sessions for intervention.
- submit their informed consent
- complete the baseline assessments.
Who cannot join
- they have primary psychiatric diagnosis other than OCD and could not understand Malay language as the virtual reality environment was developed using Malay language. Furthermore, other reasons for exclusion includes participants currently receiving other psychotherapy, and visual, hearing or physical impairments that would severely affect the experience in the VR environment.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Canselor Tuanku Muhriz UKM,
Cheras, Kuala Lumpur, 56000
About this study
Official title: A Clinical Protocol for Virtual Reality- Assisted Cognitive Behavioural Therapy Targeting Quality of Life Outcomes in Obsessive Compulsive Disorder
This study aims to evaluate the effectiveness of VR interventions in improving the psychological quality of life among OCD patients. Besides that, investigators also aim to examine the adverse effects of the virtual reality intervention on OCD patients and explore patients' perception on QOL changes following VR intervention.
Read the detailed description
This study aims to evaluate the effectiveness of virtual reality (VR) interventions in enhancing psychological QOL among individuals with OCD. It also investigates potential adverse effects of VR intervention and explore patients' perceptions of quality-of-life (QOL) changes following treatment.
A two-arm, single-blinded randomized controlled trial (RCT) with a parallel design will be conducted at the Psychiatric Clinic, Hospital Canselor Tuanku Muhriz. OCD patients will be randomly assigned in a 1:1 ratio to either a virtual reality cognitive behavioural therapy (VR-CBT) intervention group or a control intervention group. Assessments will be conducted at baseline, mid-intervention, and after completion of the intervention. Treatments for both groups will be administered individually by clinical psychologists or trained PhD students within the same clinical setting.
Participants will be recruited using purposive sampling from patients referred for psychotherapy services. Eligible participants must have a primary diagnosis of OCD, be aged 18 years and above, demonstrate willingness to participate, provide informed consent, complete baseline assessments, and commit to weekly intervention sessions. Exclusion criteria include having another primary psychiatric diagnosis, inability to understand Malay language, current involvement in other psychotherapies, and significant visual, hearing, or physical impairments that may interfere with VR participation. Reasons for refusal or exclusion will be documented.
The experimental intervention consists of VR-CBT developed during the feasibility phase. Each session includes a 10-minute orientation and warm-up, followed by three 15-minute VR training segments separated by 5-minute breaks, ending with a 5-minute wrap-up session. The intervention will utilize the Meta Quest 3 head-mounted display and handheld controllers. The control group will undergo a comparison intervention involving PowerWash games, matched in duration and training dosage to the VR-CBT condition.
Outcome measures include OCD symptom severity, psychological quality of life, and adverse effects. OCD severity will be assessed using the Yale-Brown Obsessive Compulsive Scale - Second Edition (Y-BOCS II), a clinician-rated semi-structured interview with strong psychometric properties. Psychological quality of life will be measured using the Psychological Quality of Life Questionnaire (PsychQOL), a 18-item questionnaire assessing psychological functioning and depression/anxiety symptoms. Evaluations will be conducted at pre-intervention, mid-intervention, and post-intervention stages.
In addition to quantitative measures, qualitative interviews will be conducted with participants who complete the intervention to explore perceived QOL changes following treatment. Interviews will take place within six months after intervention completion and focus on participants' experiences and perceived improvements in various QOL domains.
- Conditions
- OCD
- Being tested
- VR-CBT, G-VRET
- Keywords
- VR-CBT, VR exposure, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-CBTBehavioural
This intervention incorporate CBT and exposure techniques using virtual reality.
G-VRETBehavioural
This intervention incorporate games and exposure techniques through VR modality.
| Study group | Role | What they receive |
|---|---|---|
| VR-CBT | Experimental | Not described Receives: Behavioral: VR-CBT |
| VR exposure | Experimental | Not described Receives: Behavioral: G-VRET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms severity as assessed by Y-BOCS II
The symptoms severity are being assessed using Y-BOCS II. The items are rated on a scale of 1 to 5, while the total score ranges from 10 to 50.
Measured: The Y-BOCS will be administered at four specific assessment time points: Baseline (Session 1); mid-intervention (Session 5); post-intervention (after Session 9); and 1-year follow-up.
Psychological quality of life
Assess psychological aspect of quality of life using PsychQOL questionnaire. The responses are rated on a scale of 1 to 7, with total scores ranges from 17 to 119.
Measured: The PsychQ will be administered at four assessment points: Baseline (Session 1); mid-intervention (Session 5); post-intervention (after Session 9); and 1-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCDStudies 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
- Model description
- A two-arm, single blinded, randomized controlled trial (RCT) of parallel design will be conducted to investigate the effect of virtual reality intervention on quality of life among OCD patients. In this study, OCD patients will be randomly assigned to one of two intervention groups: virtual reality exposure(VRE) intervention or virtual reality cognitive behavioural therapy (VR-CBT) intervention. Assessments will take place before the delivery of intervention as the baseline, after five sessions of intervention, after the intervention completed and during three month follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Responsible party
- Sponsor
- Investigators
- shalisah sharip, PhD, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857577
- Sponsor's protocol ID
- UKMVRCBT
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Protocol for Virtual Reality- Assisted Cognitive Behavioural Therapy Targeting Quality of Life Outcomes in Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT07857577
- Acronym / sponsor ID
- UKMVRCBT
- Conditions
- OCD
- Keywords
- VR-CBT, VR exposure, quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Oct 2026 (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.
This study aims to evaluate the effectiveness of VR interventions in improving the psychological quality of life among OCD patients. Besides that, investigators also aim to examine the adverse effects of the virtual reality intervention on OCD patients and explore patients' perception on QOL changes following VR intervention.
Detailed description
This study aims to evaluate the effectiveness of virtual reality (VR) interventions in enhancing psychological QOL among individuals with OCD. It also investigates potential adverse effects of VR intervention and explore patients' perceptions of quality-of-life (QOL) changes following treatment.
A two-arm, single-blinded randomized controlled trial (RCT) with a parallel design will be conducted at the Psychiatric Clinic, Hospital Canselor Tuanku Muhriz. OCD patients will be randomly assigned in a 1:1 ratio to either a virtual reality cognitive behavioural therapy (VR-CBT) intervention group or a control intervention group. Assessments will be conducted at baseline, mid-intervention, and after completion of the intervention. Treatments for both groups will be administered individually by clinical psychologists or trained PhD students within the same clinical setting.
Participants will be recruited using purposive sampling from patients referred for psychotherapy services. Eligible participants must have a primary diagnosis of OCD, be aged 18 years and above, demonstrate willingness to participate, provide informed consent, complete baseline assessments, and commit to weekly intervention sessions. Exclusion criteria include having another primary psychiatric diagnosis, inability to understand Malay language, current involvement in other psychotherapies, and significant visual, hearing, or physical impairments that may interfere with VR participation. Reasons for refusal or exclusion will be documented.
The experimental intervention consists of VR-CBT developed during the feasibility phase. Each session includes a 10-minute orientation and warm-up, followed by three 15-minute VR training segments separated by 5-minute breaks, ending with a 5-minute wrap-up session. The intervention will utilize the Meta Quest 3 head-mounted display and handheld controllers. The control group will undergo a comparison intervention involving PowerWash games, matched in duration and training dosage to the VR-CBT condition.
Outcome measures include OCD symptom severity, psychological quality of life, and adverse effects. OCD severity will be assessed using the Yale-Brown Obsessive Compulsive Scale - Second Edition (Y-BOCS II), a clinician-rated semi-structured interview with strong psychometric properties. Psychological quality of life will be measured using the Psychological Quality of Life Questionnaire (PsychQOL), a 18-item questionnaire assessing psychological functioning and depression/anxiety symptoms. Evaluations will be conducted at pre-intervention, mid-intervention, and post-intervention stages.
In addition to quantitative measures, qualitative interviews will be conducted with participants who complete the intervention to explore perceived QOL changes following treatment. Interviews will take place within six months after intervention completion and focus on participants' experiences and perceived improvements in various QOL domains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A two-arm, single blinded, randomized controlled trial (RCT) of parallel design will be conducted to investigate the effect of virtual reality intervention on quality of life among OCD patients. In this study, OCD patients will be randomly assigned to one of two intervention groups: virtual reality exposure(VRE) intervention or virtual reality cognitive behavioural therapy (VR-CBT) intervention. Assessments will take place before the delivery of intervention as the baseline, after five sessions of intervention, after the intervention completed and during three month follow-up.
| Arm | Type | Receives |
|---|---|---|
| VR-CBT | Experimental | Behavioral: VR-CBT |
| VR exposure | Experimental | Behavioral: G-VRET |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Indicate interest to participate in the study,
- age 18 years and above
- able to commit to weekly sessions for intervention.
- submit their informed consent
- complete the baseline assessments.
Key exclusion criteria (1 listed)
- they have primary psychiatric diagnosis other than OCD and could not understand Malay language as the virtual reality environment was developed using Malay language. Furthermore, other reasons for exclusion includes participants currently receiving other psychotherapy, and visual, hearing or physical impairments that would severely affect the experience in the VR environment.
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 |
|---|---|---|
| VR-CBTThis intervention incorporate CBT and exposure techniques using virtual reality. | Behavioural | VR-CBT |
| G-VRETThis intervention incorporate games and exposure techniques through VR modality. | Behavioural | VR exposure |
Primary outcome
Symptoms severity as assessed by Y-BOCS II
Time frame: The Y-BOCS will be administered at four specific assessment time points: Baseline (Session 1); mid-intervention (Session 5); post-intervention (after Session 9); and 1-year follow-up.
The symptoms severity are being assessed using Y-BOCS II. The items are rated on a scale of 1 to 5, while the total score ranges from 10 to 50.
Psychological quality of life
Time frame: The PsychQ will be administered at four assessment points: Baseline (Session 1); mid-intervention (Session 5); post-intervention (after Session 9); and 1-year follow-up.
Assess psychological aspect of quality of life using PsychQOL questionnaire. The responses are rated on a scale of 1 to 7, with total scores ranges from 17 to 119.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
shalisah sharip, PhD principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-CBT and G-VRET in people with OCD, run by National University of Malaysia at 1 site in Malaysia.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms severity as assessed by Y-BOCS II (time frame: The Y-BOCS will be administered at four specific assessment time points: Baseline (Session 1); mid-intervention (Session 5); post-intervention (after Session 9); and 1-year follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.