Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
- Conditions
- MDDDepressionMajor Depressive Disorder
- Interventions
- Behavioral: Traditional Behavioral ActivationBehavioral: Extended Reality-Enhanced Behavioral Activation
- Registration Number
- NCT05525390
- Lead Sponsor
- Stanford University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Patient must meet DSM V criteria for MDD
- Patient must be at least 18 years of age
- Patient must be English speaking
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional Behavioral Activation Traditional Behavioral Activation Participants 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 Extended Reality-Enhanced Behavioral Activation Participants 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.
- Primary Outcome Measures
Name Time Method Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms 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 Outcome Measures
Name Time Method Number of Participants Who Dropped Out of Each Study Arm 3-weeks Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.
Participant's Satisfaction With the XR-Enhanced BA Treatment Assessed after session 4, at the end of week 3. This outcome was measured using the "Attitudes Toward Use " questions of the Technology Acceptance Model questionnaire. These are questions 7, 8, 9, and 10 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 4 questions, the total range was 0-16 (higher scores indicate greater acceptance).
Participant's Use of the XR Headset Assessed after session 4, at the end of week 3. This was measured by noting the amount of times the XR headset is used during the 3-week study period.
How Well Can Participants Tolerate the XR-Enhanced BA Treatment? Assessed after session 4, at the end of week 3. This was determined by the Simulator Sickness Questionnaire, which names 16 adverse symptoms and asks participants to circle as compared to baseline: No more than usual (0), Slightly more than usual (1), Moderately more than usual (2), or Severely more than usual (3), yielding a range of 0-48 (lower scores indicate greater tolerability).
Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends Assessed after session 4, at the end of week 3. This outcome was measured using the "Intention to use Technology " questions of the Technology Acceptance Model questionnaire. These are questions 11, 12, and 13 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 3 questions, the total range was 0-12 (higher scores indicate greater acceptance).
How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset? Assessed after session 4, at the end of week 3. This was measured using the Presence Questionnaire, which asks three questions and asks the participants to circle either Not at all (0), Slightly (1), Moderately (2), Strongly (3), or Very Strongly (4), yielding a range of 0-12 (higher scores indicate greater presence).
Participant's Acceptance of XR-Enhanced BA Treatment Assessed after session 4, at the end of week 3. This was measured using the overall Technology Acceptance Model questionnaire, which encompasses 13 questions and allows participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4), yielding a range of 0-52 (higher scores indicate greater acceptance).
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States