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

Gender Dysphoria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05903911
• Other study ID #: 2023-0644: RCT
• Secondary ID: UW Baldwin Endow
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Louis Lindley, MA
• Phone: 972-922-5786
• Email: llindley2[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Gender Dysphoria

Intervention

Other:
• Trans Care Web App
an educational and interactive website designed to improve coping strategies of TNB individuals

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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