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

NCT05903911 | Completed

• 4 other identifiers: 2023-0644: RCTUW Baldwin EndowmentA171600Protocol Version 10/17/24
• Study Type: interventional
• Target: 312
• 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 2 is a randomized controlled trial of the proposed intervention and will enroll 260 TNB participants.

Conditions

Gender Dysphoria

Outcome Measures

Primary Outcomes (8)

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

  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.

  before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up

• Change in Gender Congruence and Life Satisfaction Scale (GCLS) Score

  GCLS measures gender congruence and life satisfaction in a 38-item self assessment, for a total possible range of scores from 38-190 where higher values indicate greater gender congruence, greater gender-related well-being, and greater life satisfaction.

  before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up

• Change in Modified Gender Minority Stress and Resilience measure (M-GMSRM) Score

  Total scores are calculated for each scale based on summed values assigned to possible response options. The first 8 items are scored 0 for "never," 1 for "yes, before age 18," 2 for "yes, after age 18," and 3 for "yes, in the past year." Scores from these items are then summed where a higher score indicates more frequent and recent experiences of gender related prejudice. All other items are scored from 0 - 4 according to responses ranging from strongly disagree to strongly agree. Items within each subscale (i.e., non-affirmation of identity, internalized transphobia, and negative expectations for the future) are summed with high scores indicating greater distress.

  before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up

• Change in Trans and Nonbinary Coping Measure (TNCM) Score

  TNCM assesses the unique ways of coping with gender-related stress. The measure includes six subscales (Social Support/Connection (5 items); Social Activism (4 items); Hope (5 items); Strategic Gender Expression (5 items); Behavioral Avoidance (5 items); Identity Nondisclosure (4 items). Responses to items are recorded on a 5-point scale from 1 (I do not do this) to 5 (I almost always do this). Scale items are summed to create subscale scores. A higher score indicates greater frequency of use of that coping strategy.

  before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up

• Alcohol Use Disorder Identification Test

  This is scored from 0-4 where higher scores are indicative of increased dependence on alcohol.

  before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up

• Number of Days in the Past Week You Consumed Alcohol

  7 = 7 days, 6 = 6 days, 5 = 5 days, 4 = 4 days, 3 = 3 days, 2 = 2 days, 1 = 1 day, 0 =no days

  before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up

• Quantity of Alcohol Use

  How many alcoholic drinks, on average, have you had per day during the pastweek? An alcoholic drink is defined as 1 beer, 1 glass of wine, 1 shot of alcohol, or 1mixed drink. Response options: 5 = 12+ drinks, 4 = 8-11 drinks, 3 = 5-7 drinks, 2 = 3-4 drinks, 1 = 1-2 drinks, 0 =none

  before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up

• Change in Multidimensional Gender Dysphoria Measure Scores

  The Multidimensional Gender Dysphoria Measure is a 25-item survey each scored from 1 (strongly disagree) to 6 (strongly agree) for a total possible range of scores of 5-30 in each of 5 domains: Body Gender Dysphoria, Social Gender Dysphoria, Variability of Gender Dysphoria, Relief from Gender Dysphoria, and Internalized Gender Normativity. Higher scores indicate greater gender dysphoria distress.

  before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up

Study Arms (2)

Trans Care Intervention

EXPERIMENTAL

Other: Trans Care Web App

Waitlist Control

NO INTERVENTION

Interventions

Trans Care Web App OTHER

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

Trans Care Intervention

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 Publications (1)

• Lindley, L., & Budge, S. L. (2022). Development and validation of the Trans and Nonbinary Coping Measure (TNCM): A measure of trans and nonbinary specific ways of coping with gender-related stress. Psychology of Sexual Orientation and Gender Diversity. Advance online publication. https://doi.org/10.1037/sgd0000618

  BACKGROUND

Related Links

• Public Record for Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria Feasibility and Acceptability Study

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 130 participants randomized to intervention and 130 to waitlist control

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: December 12, 2024
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)