Support Groups in the Metaverse for Ukrainian Refugees (METASUPUKR)

University of Bucharest

Status: Enrolling

Conditions: Mental Health Wellness 1; Well-Being, Psychological

Treatments: Behavioral: Metaverse support group; Behavioral: In-Person support group

Study type: Interventional

Funder types: Other

Identifiers

NCT06142032

METASUPPORTGROUPS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Part of Ukrainian refugee communities

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Metaverse support group

Experimental group

Description:

Online intervention

Treatment:

Behavioral: Metaverse support group

In-Person support group

Active Comparator group

Description:

In-person intervention

Treatment:

Behavioral: In-Person support group

Waitlist

No Intervention group

Description:

Control