Support Groups in the Metaverse for Ukrainian Refugees

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Mental Health Wellness 1

Clinical Trial Details

NCT number	NCT06142032
Study type	Interventional
Source	University of Bucharest
Contact	Cezar Giosan, PhD
Phone	+40730908050
Email	giosan@outlook.com
Status	Recruiting
Phase	N/A
Start date	December 20, 2023
Completion date	August 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Support Groups in the Metaverse for Ukrainian Refugees — METASUPUKR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms