Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Stanford University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- How Well Can Participants Tolerate the VR-BA Treatment?
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Margot Paul
Principle Investigator
Stanford University
Eligibility Criteria
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
Outcomes
Primary Outcomes
How Well Can Participants Tolerate the VR-BA Treatment?
Time Frame: Assessed at the end of week 3, after session 4
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).
Participant's Use of the VR Headset
Time Frame: Assessed at the end of week 3, after session 4
This was measured by noting the amount of times the VR headset is used during the 3-week study period.
Participant's Desire to Continue Using VR After the Study Ends
Time Frame: Assessed at the end of week 3, after session 4
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).
How Present Did Individuals in the VR-BA Treatment Feel?
Time Frame: Assessed at the end of week 3, after session 4
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).
Number of Participants Who Dropped Out of Each Study Arm
Time Frame: 3-weeks
Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.
Participant's Satisfaction With the VR-BA Treatment
Time Frame: Assessed at the end of week 3, after session 4
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).
Participant's Acceptance of VR-BA Treatment
Time Frame: Assessed at the end of week 3, after session 4
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).
Secondary Outcomes
- Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms(Assessed at baseline and session 4.)