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

Gender Dysphoria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884307
• Other study ID #: 2023-0644: FAA
• Secondary ID: UW Baldwin Endow
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Louis Lindley, MA
• Phone: 972-922-5786
• Email: llindley2[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Gender Dysphoria

Intervention

Other:
• Trans Care Web App
an educational and interactive website designed to improve coping strategies of TNB individuals

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Primary	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.	post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Primary	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.	post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Primary	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	post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Primary	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.	post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Primary	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.	post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Secondary	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.	baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Secondary	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.	baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Secondary	Modified Gender Minority Stress and Resilience Measure (M-GMSRM) Score	M-GMSRM is scored from 0-100 where higher scores indicate higher stress.	baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Secondary	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.	baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Secondary	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.	baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Secondary	Alcohol Use Disorder Identification Test	This is scored from 0-40 where higher scores are indicative of increased dependence on alcohol.	baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Secondary	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	baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Secondary	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	baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)