Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- How Well Can Participants Tolerate the VR-BA Treatment?
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must meet DSM V criteria for MDD
- •Patient must be at least 18 years of age
- •Patient must be English speaking
排除标准
- •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
研究组 & 干预措施
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 three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable activities to enjoy in virtual reality.
干预措施: Virtual Reality Behavioral Activation (Device)
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 three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable or mastery activities to perform in real life.
干预措施: Behavioral Activation in real-life (Behavioral)
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 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.
结局指标
主要结局
How Well Can Participants Tolerate the VR-BA Treatment?
时间窗: 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
时间窗: 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
时间窗: 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?
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms(Assessed at baseline and session 4.)
研究者
Margot Paul
Principle Investigator
Stanford University