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

Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Wisconsin, Madison

Current Primary Outcome: DASS-21 is a composite measurement used to assess symptoms of depression, anxiety, and stress in community settings.
The 21-item survey is comprised of three subscales for Depression, Anxiety, and Stress.
Responses are provided on a 4-point Likert scale, Where 0 = Did not apply to me, 1 = applied to me some degree, or some of the time, 2 = applied to me a considerable degree or good part of time, and 3 = applied to me very much or most of the time.
Total possible range of scores is from 0 to 63, with higher scores indicating higher levels of symptoms.

Original Primary Outcome: DASS-21 is a composite measurement used to assess symptoms of depression, anxiety, and stress in community settings.
The 21-item survey is comprised of three subscales for Depression, Anxiety, and Stress.
Responses are provided on a 4-point Likert scale, Where 0 = Did not apply to me, 1 = applied to me some degree, or some of the time, 2 = applied to me a considerable degree or good part of time, and 3 = applied to me very much or most of the time.
Total possible range of scores is from 0 to 63, with higher scores indicating higher levels of symptoms.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Wisconsin, Madison

Dates:
Date Received: June 05, 2023
Date Started: 2024-10
Date Completion: {'date': '2024-10', 'type': 'ESTIMATED'}
Last Updated: 2023-06-13
Last Verified: 2023-06