Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Conditions
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Major Depressive Disorder, MDD, Depression

Intervention / Treatment
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* Behavioral: Extended Reality-Enhanced Behavioral Activation
* Behavioral: Traditional Behavioral Activation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Behavioral Activation<br>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. | Behavioral: Traditional Behavioral Activation<br>* Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.<br>|
| Experimental: XR-Enhanced Behavioral Activation<br>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. | Behavioral: Extended Reality-Enhanced Behavioral Activation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extended Reality, Virtual Reality, Behavioral Activation, Depression