Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05884307
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2023-05-22
Brief Title:
Trans Care An Online Intervention to Reduce Symptoms of Gender Dysphoria
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Trans Care An Online Intervention to Reduce Symptoms of Gender Dysphoria
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Cares 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
Aim 1 Feasibility and acceptability analysis FAA represented by this study record
Aim 2 A pilot randomized controlled trial RCT of Trans Cares 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UW Baldwin Endowment | OTHER | None | None |
| Protocol Version 1172023 | OTHER | None | None |
| A171600 | OTHER | UW Madison | None |