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Gender DysphoriaNCT05903911

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

A study testing Trans Care Web App in people with Gender Dysphoria, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gender Dysphoria
What is being tested?
Trans Care Web App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
1 siteUnited States
Study dates
12 Dec 2024to 19 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

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.

Read the 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.

Being tested
Trans Care Web App
Medical subject headings
Gender Dysphoria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trans Care Web AppOther

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

Study groups in NCT05903911
Study groupRoleWhat they receive
Trans Care InterventionExperimentalNot described
Receives: Other: Trans Care Web App
Waitlist ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. Alcohol Use Disorder Identification Test

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

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

  6. 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

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

  7. 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

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

  8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start12 Dec 2024
  3. Primary completion19 May 2025
  4. Study completion19 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
130 participants randomized to intervention and 130 to waitlist control
Masking
Single blind
Who is masked
Participant
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05903911
Sponsor's protocol ID
2023-0644: RCT
Other IDs
UW Baldwin Endowment, A171600, Protocol Version 10/17/24
Status last verified
May 2025
First submitted
5 Jun 2023
Last updated
22 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Trans Care Web App in people with Gender Dysphoria, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression, Anxiety, and Stress Scale (DASS-21) Score (time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05903911, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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