Evaluating the Efficacy of Virtual Support Groups Fostering Resilience for Gender Diverse People: a Randomized Clinical Trial in the Metaverse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 123
- Locations
- 2
- Primary Endpoint
- Gender-affirmation
Study Overview
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 = 0.25), 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Waitlist
Control
Metaverse group
Immersive online environment
Intervention: Metaverse group (Behavioral)
Standard asynchronous online group
Online environment
Intervention: Online asynchronously (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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).
Secondary Outcomes
- 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)
Investigators
Cezar Giosan
Associate Professor of Psychology
University of Bucharest