Clinical trial NCT06959992: Developing Resilience in Transgender and Nonbinary Individuals - Exploring the Impact of Social Challenges in the Metaverse
Official title: Evaluating the Efficacy of Virtual Support Groups Fostering Resilience for Gender Diverse People: a Randomized Clinical Trial in the Metaverse
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Resilience,Psychological
Well-Being, Psychological
Self-Compassion
Keywords: Metaverse
Gender minorities
Support groups
Resilience
Well-being
Randomized clinical trial
Self-compassion
Lead sponsor: University of Bucharest
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gender-affirmation
timeFrame: Up to 5 months
measure: Resilience
timeFrame: Up to 5 months
measure: Stress and mental health correlates
timeFrame: Up to 5 months
measure: Coping mechanisms
timeFrame: Up to 5 months
measure: Self-compassion
timeFrame: Up to 5 months
measure: Social support
timeFrame: Up to 5 months
measure: Positive gender identity characteristics
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Mood changes
timeFrame: Through study completion, an average of 3 months
measure: Attitudes toward self
timeFrame: Up to 5 months
measure: Assertive attitude
timeFrame: Up to 5 months
measure: Self-efficacy
timeFrame: Up to 5 months
Other outcomes:
measure: Gender dysphoria
timeFrame: Baseline
measure: Psychiatric problems
timeFrame: Baseline
measure: Microaggressions
timeFrame: Baseline
Locations:
city: Bucharest
country: Romania
facility: University of Bucharest
Study officials:
affiliation: University of Bucharest
name: Cezar Giosan, PhD
role: PRINCIPAL_INVESTIGATOR
References: