Extended 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
- 26
- 试验地点
- 1
- 主要终点
- Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms
研究概览
简要总结
The primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive extended reality (XR) headset to engage in behavioral activation (BA) for individuals diagnosed with major depressive disorder (MDD). The secondary aim of this study is to explore the efficacy of using XR to enhance BA therapy in a clinical MDD population.
详细描述
This is a treatment development trial. Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation. All groups will follow a brief-BA protocol developed for primary care settings over a four-session, three-week treatment period.
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 disorder
- •Any seizure in the last 6 months or untreated epilepsy
- •Current nonsuicidal self-injury or parasuicidal behavior
- •Current suicidal urges and intent
- •Changing psychotherapy treatment within four months of study entry
- •Changing psychotropic medication(s) within two months of study entry
研究组 & 干预措施
Traditional Behavioral Activation
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. Participants will complete the PHQ-9 and their activity monitoring and scheduling on separate worksheets.
干预措施: Traditional Behavioral Activation (Behavioral)
XR-Enhanced Behavioral Activation
Participants randomized to this arm will perform all of their behavioral activation in extended reality (XR). Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick at least four pleasurable activities to enjoy in extended reality. Participants will complete their post-XR surveys and add and schedule activities on separate worksheets.
干预措施: Extended Reality-Enhanced Behavioral Activation (Behavioral)
结局指标
主要结局
Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms
时间窗: Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).
How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using XR-BA compared to BA in real life. 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.
次要结局
- Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends(Assessed after session 4, at the end of week 3.)
- Number of Participants Who Dropped Out of Each Study Arm(3-weeks)
- Participant's Satisfaction With the XR-Enhanced BA Treatment(Assessed after session 4, at the end of week 3.)
- Participant's Use of the XR Headset(Assessed after session 4, at the end of week 3.)
- How Well Can Participants Tolerate the XR-Enhanced BA Treatment?(Assessed after session 4, at the end of week 3.)
- How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset?(Assessed after session 4, at the end of week 3.)
- Participant's Acceptance of XR-Enhanced BA Treatment(Assessed after session 4, at the end of week 3.)
研究者
Margot Paul, PsyD
Postdoctoral Fellow
Stanford University