Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05561595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2022-09-27
Brief Title:
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
HEARTS
Brief Summary:
Stigma due to health conditions increases disease burden and adversely impacts health The internalization of health-related stigma is associated with impaired mental health and quality of life The current project will test the effects of a novel transdiagnostic group counseling intervention and peer support to determine the optimal method for helping patients cope with health-related stigma reducing its internalization and enhancing patient quality of life
Detailed Description:
This randomized controlled trial RCT will test in a sample of 195 patients with high levels of internalized health-related stigma the effects of a novel transdiagnostic intervention designed to help patients cope with this stigma and to reduce its internalization Participants will be randomly assigned to one of three intervention conditions 1 a group-based counseling intervention designed to target internalized health-related stigma delivered virtually ie via telehealth 2 a general peer support group conducted via telehealth without a targeted stigma intervention or 3 a waitlist control group The counseling and peer support conditions will provide 12 weekly group sessions followed by 2 every other week sessions and 2 monthly sessions 16 sessions total over the course of 26 weeks or 6 months Participants across all conditions will complete outcome assessment visits at baselinerandomization week 12 and week 26 The waitlist control group will receive the group counseling intervention condition 1 after completing the week 26 assessment The primary trial outcome will be the change in internalized stigma from baseline to week 12 following the most intensive part of the intervention Change in internalized stigma from baseline to week 26 will be a secondary outcome to determine lasting effects of the intervention in a maintenance period with less frequent intervention Other secondary outcomes will include depression anxiety stress coping and health-related quality of life HRQOL
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 |
|---|---|---|---|
| DP2MH132938 | NIH | None | None |
| PRO00041153 | OTHER | UFIRST | httpsreporternihgovquickSearchDP2MH132938 |