Support Groups in the Metaverse for Ukrainian Refugees

NCT06142032 | Recruiting

• 1 other identifier: METASUPPORTGROUPS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness 1; Well-Being, Psychological

Keywords

Metaverse; Refugees; Support groups; Ukraine; Mental health; Well-being; Randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• Depressive symptomatology

  Depressive symptomatology will be assessed with the Patient Health Questionnaire-Severity Measure for Depression, 9 item questionnaire. Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 2-week timeframe (0- not at all; 3 - nearly every day). The scores indicate the severity of depression, ranging from minimal depression (1-4) to mild, moderate, moderately severe, or severe depression (20-27).

  Up to 9 months

• Anxiety symptomatology

  Anxiety symptomatology will be assessed with the help of General Anxiety Disorder -7 - Severity Measure for Generalized Anxiety Disorder 7 item questionnaire. The measure is a 7-question self-reported instrument designed to correspond to some of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition diagnostic criteria for GAD. Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 2-week timeframe (0 - not at all; 3 - nearly every day). The total score for the seven items ranges from 0 to 21(minimal anxiety, to mild, moderate and severe).

  Up to 9 months

Secondary Outcomes (3)

• Well-being

  Up to 9 months

• Gender Based Violence Awareness

  Up to 9 months

• Perceived Social Support

  Up to 9 months

Study Arms (3)

Metaverse support group

EXPERIMENTAL

Online intervention

Behavioral: Metaverse support group

In-Person support group

ACTIVE COMPARATOR

In-person intervention

Behavioral: In-Person support group

Waitlist

NO INTERVENTION

Control

Interventions

Metaverse support group BEHAVIORAL

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.

Metaverse support group

In-Person support group BEHAVIORAL

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.

In-Person support group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Part of Ukrainian refugee communities

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bucharest: lead

Study Sites (1)

University of Bucharest

Bucharest, 050663, Romania

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Cezar Giosan, PhD

  University of Bucharest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cezar Giosan, PhD

CONTACT

+40730908050; giosan@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 21, 2023
• Study Start: December 20, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)