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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Participants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.
Stanford University
Palo Alto, California, United States
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Assessed at the end of week 3, after session 4
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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).
Time frame: 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).
Time frame: Assessed at the end of week 3, after session 4
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.
Time frame: Assessed at baseline and session 4.