Clinical trial NCT05884307: Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
Official title: Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender Dysphoria
Keywords: coping
trans and nonbinary
online intervention
gender minority stress
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Summary of Qualitative Prompts
timeFrame: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Trans Care Intervention Specific Feasibility and Acceptability Score
timeFrame: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Digital Working Alliance Inventory (D-WAI) Score
timeFrame: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Secondary outcomes:
measure: Depression, Anxiety, and Stress Scale (DASS-21) Score
timeFrame: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Gender Congruence and Life Satisfaction Scale (GCLS) Score
timeFrame: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Modified Gender Minority Stress and Resilience Measure (M-GMSRM) Score
timeFrame: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Trans and Nonbinary Coping Measure (TNCM) Score
timeFrame: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Brief Cope Score
timeFrame: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Alcohol Use Disorder Identification Test
timeFrame: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Number of Days in the Past Week You Consumed Alcohol
timeFrame: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
measure: Quantity of Alcohol Use
timeFrame: baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stephanie Budge, PhD, LP
role: PRINCIPAL_INVESTIGATOR
References: