Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2023-12-20
2025-04-30
Brief Summary
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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
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Metaverse support group
Online intervention
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 be chosen based on the feedback received from a previous session; the first session will cover a topic chosen by the facilitator);
* Encouragement of participants to share thoughts, ideas and experiences;
* Psychoeducation on the topics;
* Summary, takeaway, feedback.
In-Person support group
In-person intervention
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 chosen based on the feedback received from a previous session; the first session will cover a topic chosen by the facilitator);
* Encouragement of participants to share thoughts, ideas and experiences;
* Psychoeducation on the topics;
* Summary, takeaway, feedback.
Waitlist
Control
No interventions assigned to this group
Interventions
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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 be chosen based on the feedback received from a previous session; the first session will cover a topic chosen by the facilitator);
* Encouragement of participants to share thoughts, ideas and experiences;
* Psychoeducation on the topics;
* Summary, takeaway, feedback.
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 chosen based on the feedback received from a previous session; the first session will cover a topic chosen by the facilitator);
* Encouragement of participants to share thoughts, ideas and experiences;
* Psychoeducation on the topics;
* Summary, takeaway, feedback.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
Yes
Sponsors
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University of Bucharest
OTHER
Responsible Party
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Cezar Giosan
Associate Professor of Psychology
Principal Investigators
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Cezar Giosan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bucharest
Locations
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University of Bucharest
Bucharest, , Romania
Countries
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Central Contacts
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Facility Contacts
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Cezar Giosan, PhD
Role: primary
References
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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.
Other Identifiers
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METASUPPORTGROUPS
Identifier Type: -
Identifier Source: org_study_id