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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine

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 data supports the effectiveness of the treatment Virtual Reality Therapy for depression?

Research shows that virtual reality therapy can significantly reduce depressive symptoms, stress, and anxiety, especially in older adults who did not respond to previous treatments. Additionally, virtual reality-based behavioral activation has been found to improve mood and daily activity levels in people with depression. ^{1 2 3 4 5}

Is virtual reality therapy safe for humans?

Research shows that virtual reality therapy is generally safe for humans. In studies involving older adults and those with anxiety disorders, participants reported no negative side effects, and many found the experience enjoyable and relaxing. ^{4 6 7 8 9}

How does virtual reality treatment for depression differ from other treatments?

Virtual reality treatment for depression is unique because it uses immersive environments to provide therapy, which can be more accessible and engaging than traditional methods. It can incorporate cognitive behavioral techniques and unique experiences like virtual pet interactions, offering a novel way to manage depressive symptoms without needing a therapist present. ^{4 5 10 11 12}

Research Team

Sina Nikayin, MD

Principal Investigator

Assistant Professor, Departement of Psychiatry, Yale University

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

I am unable to understand and give consent for treatment.

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

Timeline

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

Treatment Details

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.

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

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Virtual Reality-Based Psychoeducational Tool (VRight) for Depressive Patients. [2020]

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

Behavioral Activation through Virtual Reality for Depression: A Single Case Experimental Design with Multiple Baselines. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Adverse Effects of Virtual and Augmented Reality Interventions in Psychiatry: Systematic Review. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality Behavioral Activation for Adults With Major Depressive Disorder: Feasibility Randomized Controlled Trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Therapeutic Garden: A Promising Method Supporting the Treatment of Depressive Symptoms in Late-Life: A Randomized Pilot Study. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]

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

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

8. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality Behavioral Activation as an Intervention for Major Depressive Disorder: Case Report. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. [2020]

10. Croatia pubmed.ncbi.nlm.nih.gov

Virtual Reality-Based Interventions for Treating Depression in the Context of COVID-19 Pandemic: Inducing the Proficit in Positive Emotions as a Key Concept of Recovery and a Path Back to Normality. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

How to Treat Depression With Low-Intensity Virtual Reality Interventions: Perspectives on Translating Cognitive Behavioral Techniques Into the Virtual Reality Modality and How to Make Anti-Depressive Use of Virtual Reality-Unique Experiences. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Virtual reality for treatment compliance for people with serious mental illness. [2022]