Clinical trial NCT06142032: Support Groups in the Metaverse for Ukrainian Refugees
Official title: Support Groups in the Metaverse for Ukrainian Refugees: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Well-Being, Psychological
Keywords: Metaverse
Refugees
Support groups
Ukraine
Mental health
Well-being
Randomized clinical trial
Lead sponsor: University of Bucharest
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptomatology
timeFrame: Up to 9 months
measure: Anxiety symptomatology
timeFrame: Up to 9 months
Secondary outcomes:
measure: Well-being
timeFrame: Up to 9 months
measure: Gender Based Violence Awareness
timeFrame: Up to 9 months
measure: Perceived Social Support
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: University of Bucharest
Study officials:
affiliation: University of Bucharest
name: Cezar Giosan, PhD
role: PRINCIPAL_INVESTIGATOR
References: