Mental Health Wellness 1METASUPUKRNCT06142032
Support Groups in the Metaverse for Ukrainian Refugees
A study testing Metaverse support group and In-Person support group in people with Mental Health Wellness 1 and Well-Being, Psychological, run by University of Bucharest at 1 site in Romania.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Well-Being, Psychological
- What is being tested?
- Metaverse support group and In-Person support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteRomania
- Study dates
- 20 Dec 2023to Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part of Ukrainian refugee communities
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
University of Bucharest
Bucharest, 050663
Cezar Giosan, PhD, +40730908050, giosan@outlook.com
About this study
Official title: Support Groups in the Metaverse for Ukrainian Refugees: A Randomized Clinical 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.
Read the detailed 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).
- Being tested
- Metaverse support group, In-Person support group
- Keywords
- Metaverse, Refugees, Support groups, Ukraine, Mental health, Well-being, Randomized clinical trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metaverse support groupBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Metaverse support group | Experimental | Online intervention Receives: Behavioral: Metaverse support group |
| In-Person support group | Active comparator | In-person intervention Receives: Behavioral: In-Person support group |
| Waitlist | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Up to 9 months
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start20 Dec 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bucharest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cezar Giosan, University of Bucharest
- Investigators
- Cezar Giosan, PhD, Principal investigator, University of Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142032
- Sponsor's protocol ID
- METASUPPORTGROUPS
- Acronym
- METASUPUKR
- Status last verified
- Dec 2024
- First submitted
- 8 Nov 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39427163