Developing Resilience in Transgender and Nonbinary Individuals - Exploring the Impact of Social Challenges in the Metaverse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metaverse group, Online asynchronously.
- Who it may be relevant to
- Registry conditions: Resilience,Psychological, Well-Being, Psychological, Self-Compassion. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Efficacy of Virtual Support Groups Fostering Resilience for Gender Diverse People: a Randomized Clinical Trial in the Metaverse
Overview
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 = 0.25), 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 123 participants (total sample size) are needed. A target of 135 people (45 per group) has been set to allow for potential dropouts (\~10%). Depending on recruitment feasibility and dropout rates throughout the study, this number may be increased.
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.
Interventions
- Behavioral Metaverse group
The 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 t - Behavioral Online asynchronously
The 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-compa
Primary outcome measures
- Gender-affirmation [Time frame: Up to 5 months]
- Resilience [Time frame: Up to 5 months]
- Stress and mental health correlates [Time frame: Up to 5 months]
- Coping mechanisms [Time frame: Up to 5 months]
- Self-compassion [Time frame: Up to 5 months]
- Social support [Time frame: Up to 5 months]
- Positive gender identity characteristics [Time frame: Through study completion, an average of 3 months]
Secondary outcome measures (4)
- Mood changes [Time frame: Through study completion, an average of 3 months]
- Attitudes toward self [Time frame: Up to 5 months]
- Assertive attitude [Time frame: Up to 5 months]
- Self-efficacy [Time frame: Up to 5 months]
Eligibility criteria
Inclusion criteria
- Transgender and nonbinary individuals with a stable gender-identity or questioning
Exclusion criteria
- Presence of acute psychiatric instability (e.g., acute psychotic symptomatology or acute suicide risk)
- Not being part of the transgender population
- Younger than 18
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Romania · 1 center
- University of Bucharest — Bucharest
Identifiers
NCT: NCT06959992 · 123/01.10.2024