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Gender DysphoriaNCT05884307

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
138 participants
Where
1 siteUnited States
Study dates
23 May 2024to 28 Aug 2024
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 1 is a feasibility and acceptability study of the proposed intervention and will enroll 100 TNB participants to provide feedback to inform a follow-up randomized controlled trial.

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 this study record]
  • Aim 2) A pilot randomized controlled trial (RCT) of Trans Care's efficacy [to be registered to a separate study record]

Aim 1 involves qualitative and quantitative feedback regarding the content of the Trans Care intervention modules, impact on TNB participants well-being, and feasibility and acceptability of Trans Care intervention. Results from the FAA study will then be analyzed and presented to our community partners who will help us develop modifications to Trans Care to increase its efficacy and ease of use.

Aim 1 Hypotheses:

  • The investigators expect that qualitative responses from participants in the FAA study overall will reflect that the Trans Care intervention was feasible and helpful. Any proposed changes from participants' qualitative responses will be incorporated into the final Trans Care intervention presented in the RCT.
  • The investigators expect that participants in the FAA study will endorse high scores three scale assessment of feasibility and acceptability.

Aim 1 Endpoints:

The primary endpoint of the study is to determine if the Trans Care intervention is feasible and helpful to TNB individuals for improving their coping strategies. This will be determined through qualitative prompts and a quantitative measure of feasibility and acceptability.

Being tested
Trans Care Web App
Keywords
coping, trans and nonbinary, online intervention, gender minority stress
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 NCT05884307
Study groupRoleWhat they receive
Trans and Nonbinary AdultsExperimentalNot described
Receives: Other: Trans Care Web App

What is being measured

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

  1. Acceptability of Intervention Measure (AIM) Score

    The AIM is a 4-item measure of intervention acceptability, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, higher scores indicate higher acceptability.

    Measured: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  2. Intervention Appropriateness Measure (IAM) Score

    IAM is a 4-item measure of intervention appropriateness, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. A total mean score ranges from 1 - 5, higher scores indicate higher appropriateness.

    Measured: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  3. Feasibility of Intervention Measure (FIM) Score

    FIM is a 4-item measure of intervention feasibility, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable, with a total mean score ranging from 1 to 5, higher scores indicate higher feasibility.

    Measured: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  4. Summary of Qualitative Prompts

    Participants will be given four prompts to qualitatively assess their experience with the intervention. What you liked most? What would you change? What was most helpful? and What was least helpful?

    Thematic analysis will be conducted to analyze participants' responses to determine predominant changes suggested by participants

    Measured: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  5. Trans Care Intervention Specific Feasibility and Acceptability Score

    This measure is score from 0 to 4 in each of 5 domains: overall assessment, helpfulness, instructions, videos, and activities. Higher scores indicate higher feasibility and acceptability.

    Measured: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  6. Digital Working Alliance Inventory (D-WAI) Score

    The D-WAI is scored from 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree), for a total range of scores from 7-42 where higher scores indicate higher perceived app effectiveness.

    Measured: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

Secondary outcomes (8)

  1. Depression, Anxiety, and Stress Scale (DASS-21) Score

    DASS-21 is scored from 0-3 in each of 3 domains: depression, anxiety, and stress. Higher scores mean increased depression, anxiety, and stress.

    Measured: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  2. Gender Congruence and Life Satisfaction Scale (GCLS) Score

    GCLS asks participants to think about how they have felt over the last 6 months. Responses are scored on a 5-point Likert scale (always = 1; never = 5). A higher scores mean greater gender congruence, greater gender-related well-being, and greater life satisfaction.

    Measured: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  3. Modified Gender Minority Stress and Resilience Measure (M-GMSRM) Score

    M-GMSRM is scored from 0-100 where higher scores indicate higher stress.

    Measured: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  4. Trans and Nonbinary Coping Measure (TNCM) Score

    TNCM is scored from 0-5 where higher scores indicate greater frequency of utilization of coping strategy in each of 6 domains: Social Support / Connection, Social Activism, Hope, Strategic Gender Expression, Behavioral Avoidance, Identity Non-Disclosure.

    Measured: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  5. Brief Cope Score

    The Brief Cope survey is scored from 1-4 in each of 3 domains: problem-focused coping, emotion-focused coping, and avoidant-coping. Higher scores indicate increased coping mechanisms.

    Measured: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  6. Alcohol Use Disorder Identification Test

    This is scored from 0-40 where higher scores are indicative of increased dependence on alcohol.

    Measured: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  7. 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: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

  8. Quantity of Alcohol Use

    How many alcoholic drinks, on average, have you had per day during the past week? An alcoholic drink is defined as 1 beer, 1 glass of wine, 1 shot of alcohol, or 1 mixed 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: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)

Timeline

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

  1. First posted1 Jun 2023
  2. Study start23 May 2024
  3. Primary completion28 Aug 2024
  4. Study completion28 Aug 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05884307
Sponsor's protocol ID
2023-0644: FAA
Other IDs
UW Baldwin Endowment, Protocol Version 11/7/2023, A171600
Status last verified
Sep 2024
First submitted
22 May 2023
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 19 Sep 2024. 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?

Acceptability of Intervention Measure (AIM) Score (time frame: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)). The study lists 6 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 NCT05884307.

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 19 Sep 2024.

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