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Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma — HEARTS  

Obesity Clinical Trial

Official title:
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

Clinical Trial 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.

Clinical Trial 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 (i.e., 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 baseline/randomization, 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05561595
Study type Interventional
Source University of Florida
Contact Rebecca Pearl, PhD
Phone 352-294-5405
Email rebecca.pearl@phhp.ufl.edu
Status Not yet recruiting
Phase N/A
Start date October 15, 2024
Completion date March 31, 2027
View Details
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