Support Groups in the Metaverse for Ukrainian Refugees: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Depressive symptomatology
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of support groups held in the Metaverse, designed to promote mental health and well-being in Ukrainian refugees.
Participants:
- will be allocated to one of three conditions: (1) Metaverse support group (intervention); (2) In-Person support group (intervention); or (3) Waitlist.
- will be asked to participate in 5 support group sessions, once per week, for each intervention condition.
The Metaverse support groups will be compared with the In-Person support groups and with the Waitlist, to test:
- the efficacy of the Metaverse condition compared to the In-Person condition.
- the efficacy of the intervention conditions compared to the waitlist.
详细描述
This protocol outlines a randomized clinical trial to assess the efficacy of virtual support groups (i.e., groups meeting in the Metaverse) for Ukrainian refugees. The study will provide essential insights into the potential benefits of using the Metaverse in delivering support group sessions. The results will contribute to the development of targeted and scalable interventions and policies to promote the well-being of Ukrainian refugees.
Participants will be recruited from Ukrainian refugee communities. The participants will be randomly assigned to one of three conditions: (1) Metaverse intervention group; (2) In-person intervention group; and (3) Waitlist. Stratification will consider factors such as age, gender, trauma history, and language proficiency to achieve balanced group distributions.
The In-Person and Metaverse groups will participate in five weekly support group sessions led by licensed psychologists.
All three groups will be evaluated at (1) pre-intervention (baseline), (2) after session no. 2, (3) post-intervention, and (4) 3-month follow-up.
G*Power analysis yields a total of N=45 (f = 0.25, power = 0.95) for the three conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Part of Ukrainian refugee communities
排除标准
- •Younger than
- •Not part of the Ukrainian refugee community.
- •Formally diagnosed with a mental disorder.
- •Currently participating in any ongoing therapeutic intervention or treatment for mental health.
研究组 & 干预措施
Metaverse support group
Online intervention
干预措施: Metaverse support group (Behavioral)
In-Person support group
In-person intervention
干预措施: In-Person support group (Behavioral)
Waitlist
Control
结局指标
主要结局
Depressive symptomatology
时间窗: Up to 9 months
Depressive symptomatology will be assessed with the Patient Health Questionnaire-Severity Measure for Depression, 9 item questionnaire. Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 2-week timeframe (0- not at all; 3 - nearly every day). The scores indicate the severity of depression, ranging from minimal depression (1-4) to mild, moderate, moderately severe, or severe depression (20-27).
Anxiety symptomatology
时间窗: Up to 9 months
Anxiety symptomatology will be assessed with the help of General Anxiety Disorder -7 - Severity Measure for Generalized Anxiety Disorder 7 item questionnaire. The measure is a 7-question self-reported instrument designed to correspond to some of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition diagnostic criteria for GAD. Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 2-week timeframe (0 - not at all; 3 - nearly every day). The total score for the seven items ranges from 0 to 21(minimal anxiety, to mild, moderate and severe).
次要结局
- Well-being(Up to 9 months)
- Gender Based Violence Awareness(Up to 9 months)
- Perceived Social Support(Up to 9 months)
研究者
Cezar Giosan
Associate Professor of Psychology
University of Bucharest