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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Behavioral Activation | Active Comparator | 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. |
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| XR-Enhanced Behavioral Activation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Reality-Enhanced Behavioral Activation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margot D Paul, Psy.D. | Stanford University | Principal Investigator |
| Kim Bullock, M.D. | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38437873 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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No current plan to share data.
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation.
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| Traditional Behavioral Activation | Behavioral | Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life. |
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| Assessed after session 4, at the end of week 3. |
| Number of Participants Who Dropped Out of Each Study Arm | Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason. | 3-weeks |
| Participant's Satisfaction With the XR-Enhanced BA Treatment | 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). | Assessed after session 4, at the end of week 3. |
| Participant's Use of the XR Headset | This was measured by noting the amount of times the XR headset is used during the 3-week study period. | Assessed after session 4, at the end of week 3. |
| Participant's Acceptance of XR-Enhanced BA Treatment | 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). | Assessed after session 4, at the end of week 3. |
| How Well Can Participants Tolerate the XR-Enhanced BA Treatment? | 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). | Assessed after session 4, at the end of week 3. |
| How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset? | 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). | Assessed after session 4, at the end of week 3. |
| D001519 |
| Behavior |