Virtual Reality for Depression

(VR-KET Trial)

MA
Overseen ByMina Ansari, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
Must be taking: Ketamine/esketamine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can enhance the comfort and effectiveness of ketamine/esketamine treatments for people with depression. Participants will wear VR goggles and noise-canceling headphones to create a relaxing environment during treatments. This trial suits those already receiving ketamine/esketamine treatment for depression and continuing with maintenance sessions. However, individuals with significant hearing or vision issues, or those who struggle with English, cannot join. As an unphased trial, this study offers a unique opportunity to enhance the treatment experience with innovative VR technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves ketamine/esketamine treatment, you should discuss your current medications with the study team to ensure there are no interactions.

What prior data suggests that virtual reality is safe for use in depression treatment?

Research has shown that virtual reality (VR) therapy is generally safe for treating mental health issues. Some studies indicate it can help reduce anxiety and improve mood with few side effects. For instance, VR therapy effectively treated specific fears, with success rates between 60% and 90%. These studies did not report any major negative effects. Additionally, VR therapy has been used to help people with depression feel better, without any serious safety concerns.

While these results are encouraging, individual experiences can differ. Prospective trial participants should discuss the possible risks and benefits with their healthcare provider.12345

Why are researchers excited about this trial?

Virtual Reality is unique because it offers a new way to treat depression by immersing patients in simulated environments, potentially providing therapeutic benefits without medication. Unlike traditional treatments like antidepressants or psychotherapy, Virtual Reality can offer a more engaging and interactive experience that might help patients develop coping skills in a controlled yet dynamic setting. Researchers are excited about this approach because it opens up possibilities for personalized therapy sessions that can be tailored to individual needs, possibly leading to quicker and more sustainable improvements in mental health.

What evidence suggests that virtual reality is effective for depression?

Research has shown that virtual reality (VR) can improve mood in people with depression. In one study, a VR game lifted the spirits of young participants. Another study found that VR therapy reduced depression over time, similar to traditional treatments. Additionally, a VR meditation program was linked to lower levels of depression and anxiety. This trial will explore the effects of VR therapy on depression, building on findings that suggest VR might enhance the effects of treatments like ketamine for depression.12678

Who Is on the Research Team?

SN

Sina Nikayin, MD

Principal Investigator

Assistant Professor, Departement of Psychiatry, Yale University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are already receiving maintenance treatment for depression with ketamine/esketamine. They must be able to understand English, provide consent, and follow study procedures. It's not suitable for those with hearing or visual impairments that prevent VR use, cognitive disabilities, or other conditions that could increase risk or affect participation.

Inclusion Criteria

Written consent for the study procedures
I have finished the initial and weekly ketamine treatments and am now on a maintenance plan.
Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.

Exclusion Criteria

I am unable to understand and give consent for treatment.
Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content
Difficulty in understanding spoken or written English
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ketamine/esketamine treatment with virtual reality goggles and noise-cancelling headphones to assess the impact on treatment tolerability and effectiveness

1 session
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Virtual Reality
Trial Overview The study tests if using virtual reality to create a calming environment during ketamine/esketamine treatments can make the process more tolerable and effective in treating depression. Participants will wear VR goggles and noise-cancelling headphones during their regular treatment sessions.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Published Research Related to This Trial

A study involving 66 older adults (average age 80.5) demonstrated that immersive Virtual Reality (VR) therapy is feasible and safe for individuals with varying cognitive and physical impairments, with no reported negative side effects.
Participants generally found the VR experience enjoyable and relaxing, with 76% expressing a desire to try it again, indicating its potential as a non-pharmacological intervention to improve well-being in older adults.
Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study.Appel, L., Appel, E., Bogler, O., et al.[2020]
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.
Maximizing the impact of virtual reality exposure therapy for anxiety disorders.Anderson, PL., Molloy, A.[2021]
A systematic review of three short-term trials involving 156 participants found that virtual reality had minimal effects on treatment compliance and cognitive functioning in individuals with serious mental illness, indicating low efficacy for these outcomes.
While participants reported greater satisfaction with the virtual reality intervention compared to standard care, the overall evidence quality was low, and further high-quality studies are needed to better understand the potential benefits and risks of using virtual reality in mental health treatment.
Virtual reality for treatment compliance for people with serious mental illness.Välimäki, M., Hätönen, HM., Lahti, ME., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39709995/
The Effectiveness of Immersive Virtual Reality-Based ...VR interventions demonstrated statistically significant effects of post-treatment compared to active control conditions for alcohol use disorder ...
Virtual Reality in the treatment of depressionResults of this pilot study showed that the VR game resulted in mood improvement in 20 young healthy volunteers, no quantitative data. *Cognitive restructuring ...
Effectiveness of virtual reality therapy in the treatment ...The current findings suggest that VR therapy interventions have a positive effect on improving the anxiety state of patients with anxiety disorders.
Virtual Reality-Based Cognitive Behavior Therapy for Major ...Depression scores decreased significantly over time in both VR treatment and TAU groups, with no differences between the two groups. The ...
The impact of immersive virtual reality meditation for ...Exposure to positive emotion in a VR meditation program was associated with a significant reduction in the agitation, depression, anxiety, and negative emotion ...
Virtual reality therapy for depression treatment. VR and ...Learn how virtual reality therapy is revolutionizing depression treatment. Learn how immersive VR environments enhance depression therapy.
VR Therapy Careers: Virtual Reality Mental Health 2025Studies show success rates of 60–90% for specific phobia treatment using VR exposure therapy, though results vary by individual and condition.
Virtual reality as a clinical tool in mental health research and ...The current review provides a summary of the advantages of using VR for assessment in mental health, focusing on increasing ecological validity of highly ...
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