Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06959992

Developing Resilience in Transgender and Nonbinary Individuals - Exploring the Impact of Social Challenges in the Metaverse

Evaluating the Efficacy of Virtual Support Groups Fostering Resilience for Gender Diverse People: a Randomized Clinical Trial in the Metaverse

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
45 (estimated)
Sponsor
University of Bucharest · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMetaverse groupThe activities will be conducted in a Metaverse platform with immersive features. Each session is divided into two parts (\~2 hours duration). First, a specific social context will be represented (environmental features and static avatars) and a microaggression scenario (adapted for the chosen context) will be described. Participants are engaged in the conversation by the moderator in order to identify various psychological manifestations regarding the context (according to the SORC model) and to come up with solutions for the main, model avatar (part of the research team). Second, the debriefing part of the session will allow participants to talk about their own experiences alongside specific self-compassionate exercises. Repeated measurements will be required: pre-intervention, mid-intervention, post-intervention and at follow-up (after 3 months).
BEHAVIORALOnline asynchronouslyThe activities will be conducted asynchronously in an online platform where participants will be guided by the moderator through the same type of activities. First, a social context with specific microaggressions will be presented in a text format followed by the same requirements for participants (identifying various psychological manifestations regarding the context and coming up with solutions for the problematic situation). Second, participants will have the transcripts of several self-compassionate exercises to be done independently. A discussion forum will also require their active engagement. Repeated measurements will be required pre-interventions, mid-intervention, post-intervention and at follow-up (3 months).

Timeline

Start date
2025-09-01
Primary completion
2026-02-01
Completion
2026-02-01
First posted
2025-05-07
Last updated
2025-07-30

Locations

1 site across 1 country: Romania

Source: ClinicalTrials.gov record NCT06959992. Inclusion in this directory is not an endorsement.