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

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05884307

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Days)

101.5

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Gender Dysphoria	Other: Trans Care Web App	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2024

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trans and Nonbinary Adults	Other: Trans Care Web App an educational and interactive website designed to improve coping strategies of TNB individuals

Arm

Intervention/Treatment

Experimental: Trans and Nonbinary Adults

Other: Trans Care Web App

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

Outcome Measures

Primary Outcome Measures

Acceptability of Intervention Measure (AIM) Score [post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it)]
The AIM is a 4-item measure of intervention acceptability, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, higher scores indicate higher acceptability.
Intervention Appropriateness Measure (IAM) Score [post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it)]
IAM is a 4-item measure of intervention appropriateness, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. A total mean score ranges from 1 - 5, higher scores indicate higher appropriateness.
Feasibility of Intervention Measure (FIM) Score [post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it)]
FIM is a 4-item measure of intervention feasibility, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable, with a total mean score ranging from 1 to 5, higher scores indicate higher feasibility.
Summary of Qualitative Prompts [post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it)]
Participants will be given four prompts to qualitatively assess their experience with the intervention. What you liked most? What would you change? What was most helpful? and What was least helpful? Thematic analysis will be conducted to analyze participants' responses to determine predominant changes suggested by participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Identify as transgender, transsexual, nonbinary, and/or have a transgender history.
Experience gender dysphoria.
Time available to commit to completing a 2-3-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