Support Groups in the Metaverse for Ukrainian Refugees
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Bucharest
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Younger than 18.
Not part of the Ukrainian refugee community.
Formally diagnosed with a mental disorder.
PTSD
Trial design
Design model
Parallel
Treatments tested in this trial
Metaverse support group
BehavioralDelivery 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
BehavioralDelivery 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Metaverse support groupExperimental treatment 1 intervention
Group B: In-Person support groupActive comparator 1 intervention
Group C: WaitlistNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov