An interventional study of Metaverse support group and In-Person support group in Mental Health Wellness 1 and Well-Being, Psychological, sponsored by University of Bucharest. Recruiting at 1 site in Romania. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by University of Bucharest · Not applicable, Interventional, and Supportive care
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:
The Metaverse support groups will be compared with the In-Person support groups and with the Waitlist, to test:
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).
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 45 is below the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Bucharest is the lead sponsor of 11 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Online intervention
Behavioral: Metaverse support group
In-person intervention
Behavioral: In-Person support group
Control
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.
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.
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).
Time frame: 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).
Time frame: Up to 9 months
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).
Time frame: Up to 9 months
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.
Time frame: Up to 9 months
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.
Time frame: Up to 9 months
Plan to share: No
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Started Dec 2023 (actual). Primary completion is estimated for Apr 2025, 16 months after the start.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 16 months is close to that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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University of Bucharest