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

Primary Purpose

Gender Dysphoria

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trans Care Web App
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gender Dysphoria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Trans Care Intervention

Waitlist Control

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2023
Last Updated
June 13, 2023
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT05903911
Brief Title
Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
Official Title
Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2024 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 2 is a randomized controlled trial of the proposed intervention and will enroll 260 TNB participants.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
130 participants randomized to intervention and 130 to waitlist control
Masking
Participant
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trans Care Intervention
Arm Type
Experimental
Arm Title
Waitlist Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Trans Care Web App
Intervention Description
an educational and interactive website designed to improve coping strategies of TNB individuals
Primary Outcome Measure Information:
Title
Change in Depression, Anxiety, and Stress Scale (DASS-21) Score
Description
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.
Time Frame
before and after intervention (participants will have up to 1 week to complete intervention), 3 month follow up
Title
Change in Gender Congruence and Life Satisfaction Scale (GCLS) Score
Description
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.
Time Frame
before and after intervention (participants will have up to 1 week to complete intervention), 3 month follow up
Title
Change in Modified Gender Minority Stress and Resilience measure (M-GMSRM) Score
Description
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.
Time Frame
before and after intervention (participants will have up to 1 week to complete intervention), 3 month follow up
Title
Change in Trans and Nonbinary Coping Measure (TNCM) Score
Description
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.
Time Frame
before and after intervention (participants will have up to 1 week to complete intervention), 3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louis Lindley, MA
Phone
972-922-5786
Email
llindley2@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Budge, PhD, LP
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT05884307
Description
Public Record for Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria Feasibility and Acceptability Study

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

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