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

University of Bucharest

Status: Enrolling

Conditions: Resilience,Psychological; Self-Compassion; Well-Being, Psychological

Treatments: Behavioral: Metaverse group; Behavioral: Online asynchronously

Study type: Interventional

Funder types: Other

Identifiers

NCT06959992

123/01.10.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gender diverse people with a stable gender-identity or questioning

Exclusion criteria

• Formally diagnosed with a mental disorder
• Not being part of the gender minority population
• Younger than 18

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Metaverse group

Experimental group

Description:

Immersive online environment

Treatment:

Behavioral: Metaverse group

Standard asynchronous online group

Active Comparator group

Description:

Online environment

Treatment:

Behavioral: Online asynchronously

Waitlist

No Intervention group

Description:

Control