Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-11 @ 1:49 PM
Study NCT ID:
NCT06959992
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Resilience in Transgender and Nonbinary Individuals - Exploring the Impact of Social Challenges in the Metaverse
Sponsor:
University of Bucharest
Organization:
Study Overview
Official Title:
Evaluating the Efficacy of Virtual Support Groups Fostering Resilience for Gender Diverse People: a Randomized Clinical Trial in the Metaverse
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESILIDENT
Brief Summary:
The goal of this clinical trial is to test the effectiveness of conducting a support group in the Metaverse designed to develop and/or improve resilience in gender diverse people. By exploring the impact of different social challenges in a virtual environment, the main question it aims to answer is whether this approach on conducting support group sessions with gender diverse people will strengthen their resilience and associated abilities (self-compassion) compared to a control group and a waitlist.
Detailed Description:
The gender diverse population is inclined toward online expression as a way to connect with the community and to explore ways of handling stigma from harsh environments that they live in. The potential beneficial effects of conducting a support group to build resilience and self-compassion, with members from the gender minority community in a virtual environment, allowing the expression of gender identity through avatar customization and social interaction are being tested in the form of a Randomized Clinical Trial (RCT). There are three conditions: the virtual group (enrolling in a Metaverse platform with immersive features), the standard group (enrolling in an online forum platform) and the waitlist group.
The study is a between-subjects design with three arms and involves comparisons between pre-intervention, post-intervention and follow-up between: (a) Initial psychological states of the participants, (b) Mid-session, (c) After the support group sessions and (d) At follow-up (3 months). Participants will be randomly allocated to one of the three experimental arms.
For small-medium effect sizes assumed (f = 0.20), 3 groups and 4 measurements in time (pre- and post-intervention and one follow-up), a repeated measure analyzing between-within factors a minimum of 45 participants (total sample size) are needed. A target of 123 people (41 per group) has been set to allow for potential dropouts (\~20%).
The group sessions should be re-run several times as the chosen Metaverse platform and the general recommendations for conducting support groups limit the number of participants to 7-8 people/group.
The study is a between-subjects design with three arms and involves comparisons between pre-intervention, post-intervention and follow-up between: (a) Initial psychological states of the participants, (b) Mid-session, (c) After the support group sessions and (d) At follow-up (3 months). Participants will be randomly allocated to one of the three experimental arms.
For small-medium effect sizes assumed (f = 0.20), 3 groups and 4 measurements in time (pre- and post-intervention and one follow-up), a repeated measure analyzing between-within factors a minimum of 45 participants (total sample size) are needed. A target of 123 people (41 per group) has been set to allow for potential dropouts (\~20%).
The group sessions should be re-run several times as the chosen Metaverse platform and the general recommendations for conducting support groups limit the number of participants to 7-8 people/group.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: