Support Groups in the Metaverse for Ukrainian Refugees

Официальное название

Support Groups in the Metaverse for Ukrainian Refugees: A Randomized Clinical Trial

Обзор

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.

Подробное описание

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.

Statistical analysis plan: includes the analysis of primary and secondary outcomes, which will be assessed using predefined measures described at the measures section. Additionally, we will assess various predictors to gain insights into the factors influencing intervention outcomes. These predictors will be measured using specific instruments, including a screener (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-adult version) and Working Alliance Inventory-Short Form (WAI-S).

Вмешательства

• Поведенческое Metaverse support group
  Delivery method: Online, virtual platforms. Number of sessions: 5. Duration of each session: 1.5 hours. Sessions will adhere to evidence-based protocols for conducting support groups with a trauma-informed approach. Each session will cover a specific topic of interest related to the challenges faced by Ukrainian refugees (e.g., stress management, cultural adjustment, self-care, etc.). Support group session structure: * Introduction, check-in, ground rules; * Introducing the topic (topics will
• Поведенческое In-Person support group
  Delivery method: In-Person, traditional. Number of sessions: 5. Duration of each session: 1.5 hours. Sessions will adhere to evidence-based protocols for conducting support groups with a trauma-informed approach. Each session will cover a specific topic of interest related to the challenges faced by Ukrainian refugees (e.g., stress management, cultural adjustment, self-care, etc.). Support group session structure: * Introduction, check-in, ground rules; * Introducing the topic (topics will be

Первичные конечные точки

• Depressive symptomatology [Срок оценки: Up to 9 months]
• Anxiety symptomatology [Срок оценки: Up to 9 months]

Вторичные конечные точки (3)

• Well-being [Срок оценки: Up to 9 months]
• Gender Based Violence Awareness [Срок оценки: Up to 9 months]
• Perceived Social Support [Срок оценки: Up to 9 months]

Критерии участия

Критерии включения

\- Part of Ukrainian refugee communities

Критерии исключения

• Younger than 18.
• Not part of the Ukrainian refugee community.
• Formally diagnosed with a mental disorder.
• PTSD
• Currently participating in any ongoing therapeutic intervention or treatment for mental health.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Румыния · 1 центр

• University of Bucharest — Bucharest

Публикации

• Giosan C, Popoviciu CM, Zhamaliyeva S, Zaborot I, Deac G. Evaluating the efficacy of support groups in the metaverse for Ukrainian refugees: a protocol for a randomized clinical trial. Trials. 2024 Oct 19;25(1):697. doi: 10.1186/s13063-024-08543-6. PMID 39427163

Идентификаторы

NCT: NCT06142032 · METASUPPORTGROUPS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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