Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms
Study Overview
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.
Detailed Description
This is a treatment development trial. Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation. All groups will follow a brief-BA protocol developed for primary care settings over a four-session, three-week treatment period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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
Outcomes
Primary Outcomes
Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms
Time Frame: Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).
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.
Secondary Outcomes
- 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.)
- How Well Can Participants Tolerate the XR-Enhanced BA Treatment?(Assessed after session 4, at the end of week 3.)
- Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends(Assessed after session 4, at the end of week 3.)
- How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the 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.)
Investigators
Margot Paul, PsyD
Postdoctoral Fellow
Stanford University