Clinical trial NCT05903911: 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
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 130 participants randomized to intervention and 130 to waitlist control
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 2 is a randomized controlled trial of the proposed intervention and will enroll 260 TNB participants.

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.

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: Change in Depression, Anxiety, and Stress Scale (DASS-21) Score
timeFrame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
measure: Change in Gender Congruence and Life Satisfaction Scale (GCLS) Score
timeFrame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
measure: Change in Modified Gender Minority Stress and Resilience measure (M-GMSRM) Score
timeFrame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
measure: Change in Trans and Nonbinary Coping Measure (TNCM) Score
timeFrame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
measure: Alcohol Use Disorder Identification Test
timeFrame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
measure: Number of Days in the Past Week You Consumed Alcohol
timeFrame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
measure: Quantity of Alcohol Use
timeFrame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
measure: Change in Multidimensional Gender Dysphoria Measure Scores
timeFrame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
Secondary outcomes:
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:
citation: 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