An interventional study of Trans Care Web App in Gender Dysphoria, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Supportive care
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.
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 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:
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.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's enrollment of 312 is above the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
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Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
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Exclusion Criteria:
Other: Trans Care Web App
an educational and interactive website designed to improve coping strategies of TNB individuals
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
Plan to share: No
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University of Wisconsin, Madison