N/A
N=13
Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Major Depressive Disorder · MDD · Depression
Bottom Line
View on ClinicalTrials.gov: NCT04268316 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Participant's Desire to Continue Using VR After the Study Ends — 9.54 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual Reality Behavioral Activation (Device); Behavioral Activation in real-life (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant's Desire to Continue Using VR After the Study Ends |
9.54 | — |
| PRIMARY Number of Participants Who Dropped Out of Each Study Arm |
2; 1; 0 | — |
| PRIMARY Participant's Satisfaction With the VR-BA Treatment |
12.5 | — |
| PRIMARY Participant's Use of the VR Headset |
21.7 | — |
| PRIMARY Participant's Acceptance of VR-BA Treatment |
42.4 | — |
| PRIMARY How Well Can Participants Tolerate the VR-BA Treatment? |
2.9 | — |
| PRIMARY How Present Did Individuals in the VR-BA Treatment Feel? |
7.1 | — |
| SECONDARY Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms |
5.7; 3; .25 | — |
Summary
The primary purpose of this study is to test the safety and feasibility of virtual reality (VR) technology in the use of behavioral activation (BA) as a treatment for major depressive disorder (MDD). The secondary purpose of this study is to examine whether any evidence of clinical efficacy exists for VR delivered BA.
Eligibility Criteria
Inclusion Criteria
- Patient must meet DSM V criteria for MDD
- Patient must be at least 18 years of age
- Patient must be English speaking
Exclusion Criteria
- Substance Use Disorders in past year
- Any psychosis or bipolar I disorder
- Any seizure in the last 6 months or untreated epilepsy
- Current nonsuicidal self-injury or parasuicidal behavior
- Current suicidal urges and intent
Data sourced from ClinicalTrials.gov (NCT04268316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.