Virtual Reality for Depression

(VR-KET Trial)

Overseen By Mina Ansari, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Ketamine/esketamine

Disqualifiers: Hearing impairment, Dementia, 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: 1

Duration: 1 session

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

Who Is on the Research Team?

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

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?

Group I: Treatment group Experimental Treatment 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for treatment compliance for people with serious mental illness. Välimäki, M., Hätönen, HM., Lahti, ME., et al.[2022]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

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Studies show success rates of 60–90% for specific phobia treatment using VR exposure therapy, though results vary by individual and condition.

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