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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Gender-affirmation [Срок оценки: Up to 5 months]
• Resilience [Срок оценки: Up to 5 months]
• Stress and mental health correlates [Срок оценки: Up to 5 months]
• Coping mechanisms [Срок оценки: Up to 5 months]
• Self-compassion [Срок оценки: Up to 5 months]
• Social support [Срок оценки: Up to 5 months]
• Positive gender identity characteristics [Срок оценки: Through study completion, an average of 3 months]

Вторичные конечные точки (4)

• Mood changes [Срок оценки: Through study completion, an average of 3 months]
• Attitudes toward self [Срок оценки: Up to 5 months]
• Assertive attitude [Срок оценки: Up to 5 months]
• Self-efficacy [Срок оценки: Up to 5 months]

Критерии участия

Критерии включения

• Transgender and nonbinary individuals with a stable gender-identity or questioning

Критерии исключения

• Presence of acute psychiatric instability (e.g., acute psychotic symptomatology or acute suicide risk)
• Not being part of the transgender population
• Younger than 18

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Румыния · 1 центр

• University of Bucharest — Bucharest

Идентификаторы

NCT: NCT06959992 · 123/01.10.2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗