Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2025-05-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The current project aims to improve the well-being of trans and nonbinary (TNB) individuals through an online intervention (Trans Care) targeting the reduction of symptoms of gender dysphoria. The Trans Care intervention will involve the creation of an online intervention comprised of eight modules intended to reduce symptoms of gender dysphoria, increase active coping, and improve the well-being of TNB individuals. Aim 2 is a randomized controlled trial of the proposed intervention and will enroll 260 TNB participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria

NCT05884307

Gender Dysphoria

COMPLETED NA

Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults

NCT06409975

Healthy

RECRUITING NA

Reducing Transphobia Among Adolescents Through a Brief Video Intervention

NCT04969003

Transgenderism Depression

COMPLETED NA

Transgender Post-reassignment Urogynecologic Measures and Perceptions

NCT03293771

Gender Identity Disorder of Adult Voiding Disorders Sexual Dysfunction

UNKNOWN

Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.

NCT05273112

Gender Dysphoria

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The overall purpose of this project is to create a free intervention that can be disseminated widely throughout TNB communities to improve well-being in an easy, accessible way. Development and execution of the Trans Care intervention involves two primary aims:

* Aim 1) Feasibility and acceptability analysis (FAA) \[represented by NCT05884307\]
* Aim 2) A pilot randomized controlled trial (RCT) of Trans Care's efficacy \[represented in this study record\]

Aim 2 is a RCT in which participants' scores of psychological wellbeing and coping strategies in the intervention vs waitlist control group will be analyzed. Additionally, participants who drop out of the RCT will be asked to complete measures at dropout to determine what dose size of Trans Care (i.e., how many modules) is necessary to have a significant change in mental well-being. Finally, waitlisted participants will be offered the intervention within one month of the completion of data collection.

Aim 2 Hypotheses:

* TNB Participants who received the Trans Care intervention will demonstrate improvement on quantitative measures of psychological well-being, GD symptoms, and coping strategies compared to waitlisted individuals.
* Changes will be maintained at 3 months follow-up indicating that the Trans Care intervention has a sustained impact on improving TNB individuals' coping.

Aim 2 Endpoints:

The primary endpoint of Aim 2 will be to determine if participants who engaged the Trans Care intervention experienced psychological improvement in their mental health as a result of completing the intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gender Dysphoria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

130 participants randomized to intervention and 130 to waitlist control

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trans Care Intervention

Group Type EXPERIMENTAL

Trans Care Web App

Intervention Type OTHER

an educational and interactive website designed to improve coping strategies of TNB individuals

Waitlist Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trans Care Web App

an educational and interactive website designed to improve coping strategies of TNB individuals

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Identify as transgender, transsexual, nonbinary, and/or have a transgender history.
* Experience gender dysphoria.
* Time available to commit to completing a 4-5-hour online intervention and 1-2 hours to complete follow up surveys

Exclusion Criteria

* under 18 years old
* individual does not identify as transgender, transsexual, nonbinary, and/or have a transgender history
* does not experience gender dysphoria
* is unable to commit to the time requirements of the study
* does not have access to an internet compatible device

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes