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

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Gender Dysphoria

Treatments

Other: Trans Care Web App

Study type

Interventional

Funder types

Other

Identifiers

NCT05903911
Protocol Version 10/17/24 (Other Identifier)
A171600 (Other Identifier)
2023-0644: RCT
UW Baldwin Endowment (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

312 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

312 participants in 2 patient groups

Trans Care Intervention
Experimental group
Treatment:
Other: Trans Care Web App
Waitlist Control
No Intervention group

Trial contacts and locations

1

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Central trial contact

Louis Lindley, MA

Data sourced from clinicaltrials.gov

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