Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Study Overview
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Brief Summary
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The primary purpose of this study is to test the safety and feasibility of virtual reality (VR) technology in the use of behavioral activation (BA) as a treatment for major depressive disorder (MDD). The secondary purpose of this study is to examine whether any evidence of clinical efficacy exists for VR delivered BA.

Detailed Description
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This is a treatment development trial. Participants will be randomly assigned to BA in VR, BA in real-life, or a waitlist control group. The former two groups will follow a BA protocol developed for primary care settings over a four-week treatment period. This study is taking place over Zoom, due to COVID-19.

Official Title
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Virtual 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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* Device: Virtual Reality Behavioral Activation
* Behavioral: Behavioral Activation in real-life


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 I disorder Any seizure in the last 6 months or untreated epilepsy Current nonsuicidal self-injury or parasuicidal behavior Current suicidal urges and intent

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 either BA in VR, BA in real-life, or a waitlist control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Behavioral Activation<br>Participants randomized to this arm will perform all of their behavioral activation in virtual reality. Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable activities to enjoy in virtual reality. | Device: Virtual Reality Behavioral Activation<br>* Participants will choose four activities to complete in virtual reality over the course of the week. These activities are video 360 and range from viewing animals, to viewing nature scenes, to traveling to a different location in the world, to viewing adrenaline-pumping activities.<br>|
| Active Comparator: Behavioral Activation in real-life<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. | Behavioral: Behavioral Activation in real-life<br>* Participants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.<br>|
| No Intervention: Waitlist Control<br>Participants randomized to this arm will not receive any type of intervention and will be asked to complete the PHQ-9 once a week for three weeks (4 sessions) to track symptoms. Participants will be offered to engage in behavioral activation in real life or with virtual reality when the four weeks are complete. Their data will only be used from the time they were on the waitlist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant's Desire to Continue Using VR 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 at the end of week 3, after session 4 | 
| 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 VR-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 at the end of week 3, after session 4 | 
| Participant's Use of the VR Headset | This was measured by noting the amount of times the VR headset is used during the 3-week study period. | Assessed at the end of week 3, after session 4 | 
| Participant's Acceptance of VR-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 at the end of week 3, after session 4 | 
| How Well Can Participants Tolerate the VR-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 at the end of week 3, after session 4 | 
| How Present Did Individuals in the VR-BA Treatment Feel? | 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 at the end of week 3, after session 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms | How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using VR-BA compared to BA in real life and a waitlist control. 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 session 4. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, behavioral activation, depression