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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

NCT05884307
A171600 (Other Identifier)
Protocol Version 11/7/2023 (Other Identifier)
2023-0644: FAA
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 1 is a feasibility and acceptability study of the proposed intervention and will enroll 100 TNB participants to provide feedback to inform a follow-up randomized controlled trial.

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 this study record]
  • Aim 2) A pilot randomized controlled trial (RCT) of Trans Care's efficacy [to be registered to a separate study record]

Aim 1 involves qualitative and quantitative feedback regarding the content of the Trans Care intervention modules, impact on TNB participants well-being, and feasibility and acceptability of Trans Care intervention. Results from the FAA study will then be analyzed and presented to our community partners who will help us develop modifications to Trans Care to increase its efficacy and ease of use.

Aim 1 Hypotheses:

  • The investigators expect that qualitative responses from participants in the FAA study overall will reflect that the Trans Care intervention was feasible and helpful. Any proposed changes from participants' qualitative responses will be incorporated into the final Trans Care intervention presented in the RCT.
  • The investigators expect that participants in the FAA study will endorse high scores three scale assessment of feasibility and acceptability.

Aim 1 Endpoints:

The primary endpoint of the study is to determine if the Trans Care intervention is feasible and helpful to TNB individuals for improving their coping strategies. This will be determined through qualitative prompts and a quantitative measure of feasibility and acceptability.

Enrollment

138 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

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

138 participants in 1 patient group

Trans and Nonbinary Adults
Experimental group
Treatment:
Other: Trans Care Web App

Trial contacts and locations

1

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Central trial contact

Louis Lindley, MA

Data sourced from clinicaltrials.gov

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