VR-Enhanced Behavioral Activation for Depression

Overseen By Kim Bullock, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Psychotropics

Disqualifiers: Substance use, Psychosis, Bipolar, Seizures, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help older adults with major depressive disorder (MDD) using virtual reality (VR). Participants will engage in VR-Enhanced Behavioral Activation, a therapy technique involving activities to boost mood, through a VR headset. The goal is to determine if VR enhances the therapy's effectiveness and enjoyment. This trial may suit English-speaking adults aged 65 or older diagnosed with MDD who are not experiencing severe cognitive issues. As an unphased trial, it offers participants the chance to explore innovative therapy methods that could enhance their treatment experience.

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

The trial requires that you do not change your psychotropic medications (medications affecting mood, perception, or behavior) within two months before starting the study.

What prior data suggests that this VR-Enhanced Behavioral Activation is safe for older adults with depression?

Research has shown that using virtual reality (VR) to treat major depressive disorder (MDD) is generally safe. In one study, participants rated the VR treatment highly, with an average satisfaction score of 87%. Another study confirmed the VR method's safety and practicality for people with MDD. Participants found the VR system easy to use and provided positive feedback. Overall, these findings suggest that VR-enhanced treatment is well-received and poses no major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VR-Enhanced Behavioral Activation for depression because it offers a fresh approach by using virtual reality (VR) to engage patients. Unlike traditional treatments like medication or talk therapy, which typically involve face-to-face interactions or daily pill regimens, this method immerses patients in VR environments to encourage daily pleasurable activities. This innovative technique not only aims to boost motivation and engagement but also provides a controlled setting to practice behavioral activation, potentially making therapy more accessible and enjoyable.

What evidence suggests that VR-Enhanced Behavioral Activation is effective for depression?

Research has shown that using virtual reality (VR) to enhance behavioral activation (BA) therapy can effectively treat major depressive disorder (MDD). In this trial, participants will receive VR-Enhanced BA, performing all behavioral activation in virtual reality. Studies have found that VR-BA outperforms traditional methods, leading to a greater reduction in depression symptoms. Participants in earlier studies rated the VR treatment highly, with an average satisfaction score of 87%. In some cases, VR treatment reduced depression symptoms more effectively than other methods, such as group relaxation. These results suggest that VR-Enhanced BA could be a promising approach to managing depression in older adults. ^{1 2 4 6 7}

Who Is on the Research Team?

Kim Bullock, MD

Principal Investigator

Stanford University

Margot Paul, PsyD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with major depressive disorder (MDD) and no cognitive impairments. It's not for those with recent substance use disorders, self-harm behaviors, changes in psychotherapy or medication recently, a history of psychosis or bipolar I disorder, current suicidal thoughts, or seizures/untreated epilepsy.

Inclusion Criteria

Patient must be English speaking

I am 18 years old or older.

Patient must be without cognitive impairment

Exclusion Criteria

History of substance use disorders in the past year

History of current nonsuicidal self-injury or parasuicidal behavior

I have not changed my psychotherapy treatment in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in VR-enhanced behavioral activation therapy for depression, meeting with a clinician once a week for four weeks and performing daily VR activities.

4 weeks

5 visits (in-person)

Follow-up

Participants are monitored for changes in depression scores and acceptance of VR-enhanced BA treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VR-Enhanced Behavioral Activation

Trial Overview The study tests the use of virtual reality (VR) to enhance Behavioral Activation (BA) therapy for treating depression in older adults. It aims to see if VR makes BA more effective and how patients handle this tech-enhanced treatment.

How Is the Trial Designed?

Group I: VR-Enhanced BA Experimental Treatment 1 Intervention

Participants will perform all of their behavioral activation in virtual reality (VR). Participants will meet with the clinician once a week for four weeks (5 sessions). In between weekly therapy sessions, participants will be asked to pick at least one pleasurable activity to enjoy in VR per day. Participants will complete their post-VR surveys and add and schedule activities on separate worksheets.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. mental.jmir.org mental.jmir.org/2024/1/e52326

Examining the Efficacy of Extended Reality–Enhanced ... This study went beyond examining simple feasibility and tested the clinical efficacy of XR-BA compared to traditional BA. We specifically ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9123544/

Virtual Reality Behavioral Activation for Adults With Major ... Overall, the participants who completed the protocol “agreed” that the VR treatment was acceptable, with an average rating of 87% (45.32/52) acceptability, and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666915325000423

Virtual Reality in the treatment of depression IVR was more effective than group relaxation for reducing anxiety and depressive symptoms: adjusted mean difference for depression (GDS) was 4.10 points, with a ...

4. trial.medpath.com trial.medpath.com/clinical-trial/372245d12cdd828a/nct07188623-virtual-reality-behavioral-activation-older-adults-depression

Virtual Reality-Enhanced Behavioral Activation for Older ... The secondary aim of this study is to explore the efficacy of using VR to enhance BA therapy in a clinical MDD older adult population. Detailed Description.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38437873/

Examining the Efficacy of Extended Reality-Enhanced ... Examining the Efficacy of Extended Reality-Enhanced Behavioral Activation for Adults With Major Depressive Disorder: Randomized Controlled Trial.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35404830/

Virtual Reality Behavioral Activation for Adults With Major ... Conclusions: The findings of this study demonstrate that VR BA is safe and feasible to explore for the treatment of MDD. This study documented ...

7. mdpi.com mdpi.com/resolver?pii=jcm11051262

Behavioral Activation through Virtual Reality for Depression The promising results of the present study suggest that the proposed VR-based BA intervention might represent a valid approach to behaviorally activate ...