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

May 24, 2026 updated by: Cezar Giosan, University of Bucharest

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Romania
    • Bucharest
      • Bucharest, Bucharest, Romania, 050663
        • Recruiting
        • University of Bucharest
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Waitlist
Control
Experimental: Metaverse group
Immersive online environment
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 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).
Active Comparator: Standard asynchronous online group
Online environment
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-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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gender-affirmation
Time Frame: Up to 5 months
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
Time Frame: Up to 5 months
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
Time Frame: Up to 5 months
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
Time Frame: Up to 5 months
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
Time Frame: Up to 5 months
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
Time Frame: Up to 5 months
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
Time Frame: Through study completion, an average of 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mood changes
Time Frame: Through study completion, an average of 3 months
Short mood check questions for the beggining and end of the sessions with items from The World Health Organization-Five Well-Being Index (6-point Likert scale).
Through study completion, an average of 3 months
Attitudes toward self
Time Frame: Up to 5 months
Changes in self-focused attention specific to gender minorities with the Gender Identity Reflection and Rumination Scale, containing 15 items on a 4-point Likert scale (1 - almost never to 4 - almost always). Higher scores for reflection mean better outcomes.
Up to 5 months
Assertive attitude
Time Frame: Up to 5 months
Changes in assertiveness are assessed with the Short Form of the Simple Rathus Assertiveness Scale, with 19 items on a 6-point Likert response format (1 - very unlike me to 6 - very much like me). Higher scores mean better outcomes.
Up to 5 months
Self-efficacy
Time Frame: Up to 5 months
Assessing enhacement in self-efficay with the General Self-Efficacy Scale with 10 items on a 4-point Likert scale (1 - Not true at all to 4 - Exactly true). Higher scores mean better outcomes.
Up to 5 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gender dysphoria
Time Frame: Baseline
Gender dysphoric symptoms are assessed pre-intervention (at baseline) to establish an initial level of gender-dysphoria for participants with the Gender Preoccupation and Stability Questionnaire containing 14 items with a 5-point response Likert scale. Higher scores mean increased gender dysphoria.
Baseline
Psychiatric problems
Time Frame: Baseline
The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure is used for a primary screening process at baseline to identify potential elevated psychiatric problems. Higher scores mean worse mental health conditions.
Baseline
Microaggressions
Time Frame: Baseline
Past experiences of microaggressions are assessed with two scales, one for binary transgender participants (Gender Identity Microaggressions Scale) containing 14 items, and one for nonbinary transgender participants (The Nonbinary Gender Microaggressions) Scale containing 23 items. Higher scores mean negative experiences with microaggresions.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bucharest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cezar Giosan, PhD, University of Bucharest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 123/01.10.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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