Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT04268316|
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder MDD Depression||Device: Virtual Reality Behavioral Activation Behavioral: Behavioral Activation in real-life||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.|
|Official Title:||Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder|
|Actual Study Start Date :||May 18, 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Virtual Reality Behavioral Activation
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 four weeks. In between weekly therapy sessions, participants will pick four pleasurable activities to enjoy in virtual reality.
Device: Virtual Reality Behavioral Activation
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.
Active Comparator: Behavioral Activation in real-life
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 four weeks. In between weekly therapy sessions, participants will pick four pleasurable or mastery activities to perform in real life.
Behavioral: Behavioral Activation in real-life
Participants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.
No Intervention: Waitlist Control
Participants randomized to this arm will not receive any type of intervention and will be asked to complete the PHQ-9 once a week 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.
- Participant's desire to continue using VR after the study ends [ Time Frame: 4-weeks ]This outcome will be 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, Disagree, Neutral, Agree, or Strongly Agree.
- Rates of dropout of VR-BA [ Time Frame: 4-weeks ]Participant treatment dropout will be compared across each study arm.
- Participant's satisfaction with the VR-BA treatment [ Time Frame: 4-weeks ]This outcome will be 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, Disagree, Neutral, Agree, or Strongly Agree.
- Participant's use of the VR headset [ Time Frame: 4-weeks ]This will be measured by noting the amount of times the VR headset is used.
- Participant's acceptance of VR-BA treatment [ Time Frame: 4-weeks ]This will be measured using the overall Technology Acceptance Model questionnaire, which encompasses 13 questions and allows participants the option of circling Strongly Disagree, Disagree, Neutral, Agree, or Strongly Agree.
- How well can participants tolerate the VR-BA treatment? [ Time Frame: 4-weeks ]This will be determined by the Simulator Sickness Questionnaire, which names 16 adverse symptoms and asks participants to circle as compared to baseline: No more than usual, Slightly more than usual, Moderately more than usual, or Severely more than usual.
- How present did individuals in the VR-BA treatment feel? [ Time Frame: 4-weeks. ]This will be measured using the Presence Questionnaire, which asks three questions and asks the participants to circle either Not at all, Slightly, Moderately, Strongly, or Very Strongly.
- Clinical efficacy of using VR as a tool to deliver BA [ Time Frame: 4-weeks ]How participants' depression scores 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268316
|Contact: Margot D Paul, MSfirstname.lastname@example.org|
|Contact: Kim Bullock, MDemail@example.com|
|Principal Investigator:||Kim Bullock, MD||Stanford University|
|Study Director:||Margot Paul, MS||Stanford University|