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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gender Dysphoria

Intervention / Treatment
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* Other: Trans Care Web App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans and Nonbinary Adults<br> | Other: Trans Care Web App<br>* an educational and interactive website designed to improve coping strategies of TNB individuals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention Measure (AIM) Score | 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. | post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it) | 
| Intervention Appropriateness Measure (IAM) Score | 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. | post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it) | 
| Feasibility of Intervention Measure (FIM) Score | 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. | post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it) | 
| Summary of Qualitative Prompts | 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 | post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coping, trans and nonbinary, online intervention, gender minority stress