Support Groups in the Metaverse for Ukrainian Refugees

Mental Health Wellness 1 Clinical Trial

— METASUPUKR  

Official title:

Support Groups in the Metaverse for Ukrainian Refugees: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142032
• Other study ID #: METASUPPORTGROUPS
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: University of Bucharest
• Contact: Cezar Giosan, PhD
• Phone: +40730908050
• Email: giosan[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Romania	University of Bucharest	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
University of Bucharest

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Well-being	The World Health Organization - Five Well-Being Index is used to assess the well-being of participants. The measure is a 5-item instrument consisting of statements that respondents rate on a 6-point Likert scale (0 - at no time; 5 - all of the time). The statements are rated in relation to the past two weeks. The raw scores range from 0 to 25 and are multiplied by 100 to give the final score which ranges from 0 (the worst well-being) to 100 (the best well-being).	Up to 9 months
Secondary	Gender Based Violence Awareness	Gender-based violence awareness will be assessed through five general knowledge questions about GBV. Participants will be asked to indicate the correct answer from a list of statements. Each correct answer receives one point. The total score ranges from 0 (no GBV awareness at all) to 5 (aware of GBV). The questions were developed in collaboration with an NGO focused on gender-based violence promotion among Ukrainian refugees.	Up to 9 months
Secondary	Perceived Social Support	The Multidimensional Scale of Perceived Social Support is used to assess the Perceived Social Support. The questionnaire is a 12-item self-report instrument with items measured on a 7-point Likert scale (0 - very strongly disagree; 7 - very strongly agree). Participants are asked to indicate their preference for each statement provided in the measure. The statements refer to 3 subdomains - Significant Other, Family, and Friends and the scores can be calculated both for each subscale and as a total. Total scores range from 12 to 84. Scores ranging from 12 to 35 represent low perceived social support, 36 to 60 represent medium perceived social support, and 61 to 84 represent high perceived social support.	Up to 9 months