Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
1 other identifier
interventional
26
1 country
1
Brief Summary
The primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive extended reality (XR) headset to engage in behavioral activation (BA) for individuals diagnosed with major depressive disorder (MDD). The secondary aim of this study is to explore the efficacy of using XR to enhance BA therapy in a clinical MDD population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable major-depressive-disorder
Started Dec 2022
Shorter than P25 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedStudy Start
First participant enrolled
December 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2023
CompletedSeptember 22, 2025
September 1, 2025
7 months
August 30, 2022
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms
How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using XR-BA compared to BA in real life. The PHQ-9 is a 9-question screener with a score range of 0-29, with 29 indicating the most severe depression and 0 indicating a lack of depression symptoms. The greater the change over time, the greater the symptom reduction.
Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).
Secondary Outcomes (7)
Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends
Assessed after session 4, at the end of week 3.
Number of Participants Who Dropped Out of Each Study Arm
3-weeks
Participant's Satisfaction With the XR-Enhanced BA Treatment
Assessed after session 4, at the end of week 3.
Participant's Use of the XR Headset
Assessed after session 4, at the end of week 3.
Participant's Acceptance of XR-Enhanced BA Treatment
Assessed after session 4, at the end of week 3.
- +2 more secondary outcomes
Study Arms (2)
Traditional Behavioral Activation
ACTIVE COMPARATORParticipants randomized to this arm will perform all of their behavioral activation in real life. Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable or mastery activities to perform in real life. Participants will complete the PHQ-9 and their activity monitoring and scheduling on separate worksheets.
XR-Enhanced Behavioral Activation
EXPERIMENTALParticipants randomized to this arm will perform all of their behavioral activation in extended reality (XR). Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick at least four pleasurable activities to enjoy in extended reality. Participants will complete their post-XR surveys and add and schedule activities on separate worksheets.
Interventions
Participants will choose at least four "activities" to complete in Oculus extended reality over the course of the week. These activities are chosen from the Oculus and may include video 360, social interactions, gaming, etc.
Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.
Eligibility Criteria
You may qualify if:
- Patient must meet DSM V criteria for MDD
- Patient must be at least 18 years of age
- Patient must be English speaking
You may not qualify if:
- Substance Use Disorders in past year
- Any psychosis or bipolar disorder
- Any seizure in the last 6 months or untreated epilepsy
- Current nonsuicidal self-injury or parasuicidal behavior
- Current suicidal urges and intent
- Changing psychotherapy treatment within four months of study entry
- Changing psychotropic medication(s) within two months of study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94304, United States
Related Publications (1)
Paul M, Bullock K, Bailenson J, Burns D. Examining the Efficacy of Extended Reality-Enhanced Behavioral Activation for Adults With Major Depressive Disorder: Randomized Controlled Trial. JMIR Ment Health. 2024 Apr 15;11:e52326. doi: 10.2196/52326.
PMID: 38437873BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margot D Paul, Psy.D.
Stanford University
- STUDY CHAIR
Kim Bullock, M.D.
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Fellow
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 1, 2022
Study Start
December 19, 2022
Primary Completion
July 24, 2023
Study Completion
July 24, 2023
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
No current plan to share data.