Virtual Reality for OCD

(VR-TMS Trial)

Overseen By Mina Ansari

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Seizure disorder, Dementia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will focus on the use of Virtual Reality (VR) technology in patients receiving treatment using Transcranial Magnetic Stimulation (TMS) for Obsessive-Compulsive Disorder (OCD)

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Virtual Reality Therapy for OCD?

Research shows that Virtual Reality (VR) therapy can help people with OCD by creating controlled environments that provoke anxiety, similar to real-life situations. Studies found that VR therapy can improve symptoms in OCD patients, especially those with contamination fears, by allowing them to face their fears in a safe and controlled way. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating OCD and other conditions?

Research shows that virtual reality therapy is generally safe for treating anxiety disorders, including OCD. It is as effective as traditional exposure therapy and offers advantages like better engagement and adherence to tasks. ^{1 3 4 6 7}

How is virtual reality treatment different from other treatments for OCD?

Virtual reality treatment for OCD is unique because it allows patients to experience controlled, anxiety-provoking scenarios in a virtual environment, which can be more engaging and flexible compared to traditional exposure therapy. This method can help overcome the limitations of simulating intrusive thoughts in clinical settings, potentially improving patient adherence and treatment outcomes. ^{1 2 3 4 8}

Research Team

Sina Nikayin, MD

Principal Investigator

Assistant Professor, Departement of Psychiatry, Yale University

Eligibility Criteria

This trial is for adults with OCD who are deemed suitable for TMS treatment by a Yale psychiatrist. Participants must be willing to follow the study's procedures and requirements, understand English, and not have hearing or visual impairments that would affect VR use.

Inclusion Criteria

Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.

I have been approved for TMS by a Yale psychiatrist for my OCD.

I am 18 years old or older.

Exclusion Criteria

Difficulty in understanding spoken or written English

Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content

Any implanted medical device, risk of interference with which by the VR device in the investigator's judgment can put patient at additional undue risk

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Transcranial Magnetic Stimulation (TMS) treatment with Virtual Reality (VR) technology for Obsessive-Compulsive Disorder (OCD)

6-8 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Virtual Reality

Trial Overview The study examines how using Virtual Reality (VR) technology before Transcranial Magnetic Stimulation (TMS) can impact the treatment of Obsessive-Compulsive Disorder (OCD).

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

This single arm will include all participants of the study, who will all receive the intervention

Virtual Reality is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Functional Dyspepsia
• Irritable Bowel Syndrome (IBS)
• Gastroparesis

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Findings from Research

A single-session automated Virtual Reality exposure therapy (VRET) for fear of spiders demonstrated a significant reduction in phobia symptoms (effect size d = 1.26) in a study of 25 participants, with effects maintained at a six-month follow-up.

The intervention was found to be practical and tolerable, suggesting that automated VRET could serve as an effective self-help treatment for specific phobias in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamified, Automated Virtual Reality Exposure Therapy for Fear of Spiders: A Single-Subject Trial Under Simulated Real-World Conditions. Lindner, P., Miloff, A., Bergman, C., et al.[2022]

Virtual reality exposure therapy for anxiety disorders is shown to be safe and effective, often matching the efficacy of traditional in-person exposure therapy.

The increasing availability of affordable virtual reality systems and the development of self-guided programs could significantly enhance access to treatment for anxiety disorders, potentially addressing mental health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. Anderson, PL., Molloy, A.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of In Virtuo Exposure and Response Prevention Treatment Using Cognitive-Behavioral Therapy for Obsessive-Compulsive Disorder: A Study Based on a Single-Case Study Protocol. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Virtual Reality on Emotional Response and Symptoms Provocation in Patients With OCD: A Systematic Review and Meta-Analysis. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Management of obsessive-compulsive disorder with virtual reality-based exposure. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Exposure therapy in a virtual environment: Validation in obsessive compulsive disorder. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Design and validation of virtual environments for the treatment of cleaning obsessive-compulsive disorder. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Gamified, Automated Virtual Reality Exposure Therapy for Fear of Spiders: A Single-Subject Trial Under Simulated Real-World Conditions. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Virtual reality in diagnosis and treatment of obsessive-compulsive disorder]. [2023]