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

NCT06959992 | Recruiting

• 1 other identifier: 123/01.10.2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Metaverse; Gender minorities; Support groups; Resilience; Well-being; Randomized clinical trial; Self-compassion

Outcome Measures

Primary Outcomes (7)

• Gender-affirmation

  Assessing changes in levels of comfort and satisfaction related to gender identity with The Psychological Gender Affirmation Scale which contains 5 items, ranging from 1 - Not at all to 5 - Extremely. Higher scores indicate better outcomes.

  Up to 5 months

• Resilience

  Assessing changes in resilient attitudes from a general perspective with the Brief Resilience Scale (6 items on a 5-point Likert response scale, ranging from 1 - Strongly disagree to 5 - Strongly agree) and from a specific view of gender minority resilience with the Gender Minority Stress and Resilience Measure. Only the resilience items will be selected from the 58-items scale (5 items for Community connectedness and 8 items for Pride). Responses range from 0 - Strongly disagree to 4 - Strongly agree. Higher scores indicate better outcomes.

  Up to 5 months

• Stress and mental health correlates

  Assessing changes in perceived distal (Discrimination, Rejection and Victimization - 17 items) and proximal stress factors (Non-affirmation of gender identity, Internalized transphobia, Nondisclosure and Negative future expectations - 28 items) with the Gender Minority Stress and Resilience Measure (selecting only stress-related items) and in mental health symptoms with the Depression, Anxiety, Stress Scale (DASS), containing 21 items. Higher scores mean worse outcomes.

  Up to 5 months

• Coping mechanisms

  Assessing changes in approached coping mechanisms with the Trans and Nonbinary Coping Measure containing 28 items and 6 subscales with both adaptive and maladaptive types of coping, on a 5-point Likert scale (1 - I do not do this to 5 - I almost always do this). Scoring significance depends on the nature of the coping mechanisms.

  Up to 5 months

• Self-compassion

  Assessing changes in self-compassionate attitudes with the Short Form of the Self-Compassion Scale, containing 12 items on a 5-point Likert response scale ranging from 1 - Almost never to 5 - Almost always. Higher scores mean better outcomes.

  Up to 5 months

• Social support

  Assessing changes in perceived social support with the Multidimensional Scale of Perceived Social Support, containing 12 items on a 7-point Likert response scale (ranging rom 1 - Very strongly disagree to 7 - Very strongly agree). Higher scores mean better outcomes.

  Up to 5 months

• Positive gender identity characteristics

  Assessing changes in positive characteristics of gender identity with the Transgender Positive Identity Measure with 24 items with a 7-point Likert response scale (ranging from 1 - Strongly disagree to 7 - Strongly agree).

  Through study completion, an average of 3 months

Secondary Outcomes (4)

• Mood changes

  Through study completion, an average of 3 months

• Attitudes toward self

  Up to 5 months

• Assertive attitude

  Up to 5 months

• Self-efficacy

  Up to 5 months

Other Outcomes (3)

• Gender dysphoria

  Baseline

• Psychiatric problems

  Baseline

• Microaggressions

  Baseline

Study Arms (3)

Metaverse group

EXPERIMENTAL

Immersive online environment

Behavioral: Metaverse group

Standard asynchronous online group

ACTIVE COMPARATOR

Online environment

Behavioral: Online asynchronously

Waitlist

NO INTERVENTION

Control

Interventions

Metaverse group BEHAVIORAL

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 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).

Metaverse group

Online asynchronously BEHAVIORAL

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-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).

Standard asynchronous online group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bucharest: lead

Study Sites (1)

University of Bucharest

Bucharest, Bucharest, 050663, Romania

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Cezar Giosan, PhD

  University of Bucharest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cezar Giosan, PhD

CONTACT

+40730908050; giosan@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 7, 2025
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)