Cognitive Behavioral Immersion: A Randomized Control Trial of Peer-Based Coaching in the Metaverse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
This study will test a new cognitive-behavioral skills training program (CBI) delivered in the metaverse. Although initial evidence suggested CBI was feasible for individuals experiencing depression or anxiety, CBI's effectiveness compared to no intervention has yet to be determined. The intervention may be delivered through virtual reality as well as flat-screen devices, such as a computer, which may also affect CBI's effectiveness.
The study will enroll up to 306 participants with depression. One third of the participants will access CBI through virtual reality, one third of the participants will access CBI through a flat-screen device, and one third of the participants will be asked not to attend CBI sessions for the first 8 weeks of participation of the trial. For both CBI conditions, treatment will be provided over 8 weeks, with a 6-month follow-up period. Enrollment will be ongoing and groups will occur simultaneously.
Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. They will then receive 8-weeks of treatment. Participants will complete brief weekly self-report questionnaires throughout their time in the study.
详细描述
Cognitive behavioral therapy (CBT) is one of the most effective tools for the treatment of depression and anxiety. Despite its many strengths, CBT-based clinical care is often very expensive and difficult to access. To address problems of accessibility, the field is increasingly utilizing lay therapists (also commonly referred to as coaches or peers) to provide cognitive behavioral coaching. There is also accumulating evidence indicating that technology can be used to deliver affordable and accessible treatments with outcomes comparable to traditional face-to-face psychotherapy treatments (Karyotaki et al., 2021). In particular, the metaverse (Internet-connected 3-D virtual environments have also that allow end-users to interact as avatars) may be a distinctively powerful medium through which to deliver engaging, affordable, accessible, and scalable mental health interventions. In addition, the use of social virtual reality (VR) mental health interventions is relatively unexplored, yet the sense of presence ("being there") it provides may be useful to increase immersiveness in a digital intervention or facilitate social interaction in a digital space.
Therefore, the investigators plan to conduct a randomized controlled trial on CBI in order to investigate its effectiveness among different groups of people and investigate the role immersive VR, as opposed to a flat screen, may play in predicting outcome measures. Upon joining the study, participants are asked to complete surveys once a week for 8 weeks and brief monthly follow-up surveys for 6 months. If you are randomized to either of the CBI conditions, you will also be asked to attend 8 weekly 1-hour sessions through a virtual application (from a VR headset or flat-screen, depending on your condition). This study seeks to address the main following research questions: (1) Is CBI efficacious? (and for whom is it more or less efficacious?) And (2) Does immersive VR confer any advantage over and above accessing CBI via less immersive flat screen devices?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •18 years of age or older
- •Proficient in reading and speaking English
- •Have a computer with a stable internet connection
- •Score at or above the clinical threshold on the Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001)
排除标准
- •Sufficiently elevated levels of negative thoughts such that the individual is considered at high risk of harm, according to the Columbia Suicide Severity Rating Scale (CSSRS)
研究组 & 干预措施
CBI-Virtual Reality
Over 8 weekly 1-hour sessions, participants will learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm will access these sessions using a virtual reality headset.
干预措施: CBI (Behavioral)
CBI-Flat Screen
Over 8 weekly 1-hour sessions, participants will learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills and habits that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm will access these sessions using a flat-screen device, such as a computer.
干预措施: CBI (Behavioral)
Delayed-Access Control
Participants randomized to this arm will be asked not to attend CBI sessions.
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: Post-treatment (8-weeks) and follow-up (6-months)
The PHQ-9 (Kroenke et al., 2001) is a 9-item self-report measure with strong psychometric properties that mirrors the nine criteria for evaluating whether someone meets criteria for major depressive disorder (MDD) in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV; American Psychiatric Association, 1994). Scores range from 0 to 27, with higher scores indicating great symptom severity.
Patient Health Questionnaire-9
时间窗: post-intervention week 8
The Patient Health Questionnaire is a 9-item self-report measure of depression symptom severity. Scores range from 0 to 27, with higher scale scores indicating greater depression symptom severity. Scale scores were assessed and are presented for post-intervention week 8.
次要结局
- WHO Quality of Life-Brief (QOL)(Post-treatment (8-weeks) and 1-item version at follow-up (6-months))
- Generalized Anxiety Disorder Questionnaire (GAD-7)(Post-treatment (8-weeks) and follow-up (6-months))
- Generalized Anxiety Disorder-7(post-intervention week 8)
- World Health Organization Quality of Life-General Scale(post-intervention week 8)
研究者
Iony Ezawa
Assistant Professor
University of Southern California
