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Completed

NCT Number: NCT05884307

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

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.

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Key information

Conditions

Gender Dysphoria Mental Disorders Sexual Dysfunctions, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans Care Web App

Other

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

Primary outcomes

  1. 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 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.

  2. Intervention Appropriateness Measure (IAM) Score

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

    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.

  3. Feasibility of Intervention Measure (FIM) Score

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

    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.

  4. Summary of Qualitative Prompts

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

    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

  5. Trans Care Intervention Specific Feasibility and Acceptability Score

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

    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.

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

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

    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.

Secondary outcomes

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

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

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

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

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

    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.

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

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

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

  4. Trans and Nonbinary Coping Measure (TNCM) Score

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

    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.

  5. Brief Cope Score

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

    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.

  6. Alcohol Use Disorder Identification Test

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

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

  7. Number of Days in the Past Week You Consumed Alcohol

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

    7 = 7 days, 6 = 6 days, 5 = 5 days, 4 = 4 days, 3 = 3 days, 2 = 2 days, 1 = 1 day, 0 = no days

  8. Quantity of Alcohol Use

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

    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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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