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

NCT05884307 | Completed

• 4 other identifiers: 2023-0644: FAAUW Baldwin EndowmentProtocol Version 11/7/2023A171600
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Dysphoria

Keywords

coping; trans and nonbinary; online intervention; gender minority stress

Outcome Measures

Primary Outcomes (6)

• 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 5 hours to complete, participant has up to 1 month 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 5 hours to complete, participant has up to 1 month 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 5 hours to complete, participant has up to 1 month 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 5 hours to complete, participant has up to 1 month to complete it)

• Trans Care Intervention Specific Feasibility and Acceptability Score

  This measure is score from 0 to 4 in each of 5 domains: overall assessment, helpfulness, instructions, videos, and activities. Higher scores indicate higher feasibility and acceptability.

  post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

• Digital Working Alliance Inventory (D-WAI) Score

  The D-WAI is scored from 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree), for a total range of scores from 7-42 where higher scores indicate higher perceived app effectiveness.

  post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

Secondary Outcomes (8)

• Depression, Anxiety, and Stress Scale (DASS-21) Score

  baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

• Gender Congruence and Life Satisfaction Scale (GCLS) Score

  baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

• Modified Gender Minority Stress and Resilience Measure (M-GMSRM) Score

  baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

• Trans and Nonbinary Coping Measure (TNCM) Score

  baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

• Brief Cope Score

  baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

Study Arms (1)

Trans and Nonbinary Adults

EXPERIMENTAL

Other: Trans Care Web App

Interventions

Trans Care Web App OTHER

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

Trans and Nonbinary Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Links

• Study Hypothesis and Design Plan Pre-registered on OSF

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Stephanie Budge, PhD, LP

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: May 23, 2024
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)