Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

Obesity Clinical Trial

— HEARTS  

Official title:

Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05561595
• Other study ID #: IRB202201862
• Secondary ID: DP2MH132938PRO00
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Rebecca Pearl, PhD
• Phone: 352-294-5405
• Email: rebecca.pearl[@]phhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 195
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• At least one of the following stigmatized health conditions:

• Obesity (defined by a body mass index of 30 kg/m2 or higher)

• Skin disease (including but not limited to psoriasis, eczema, or vitiligo)

• Cancer (including but not limited to lung, breast, cervical, colorectal, gynecologic, prostate, or head and neck; including individuals in remission)

• HIV

• Type 1 or type 2 diabetes

• Chronic pain

• Reported internalization of health-related stigma, as determined by a pre-specified cutoff score on internalized stigma measure and confirmed by interview

Participants must have availability to attend weekly virtual group meetings for 12 weeks, followed by every-other-week and monthly meetings through 26 weeks, in the evening on a specified weekday. Participants must be willing to actively participate and share information about themselves in the group meetings.

Participants must be able to read, comprehend, and speak English in order to participate in group sessions and complete study questionnaires.

Participation requires an electronic device (computer, tablet, or phone) with video capabilities and internet, wi-fi, or cellular data in order to attend group sessions and complete study questionnaires. Individuals who do not have such devices or internet access will still be eligible to participate. In such cases, screening procedures will be conducted by phone, and randomized participants will be provided with web cameras or internet-enabled devices (and/or provided with pre-paid cellular data) to facilitate participation.

Exclusion Criteria:

• Current or recent (past 3 months) receipt of psychotherapy or a psychosocial or peer support intervention, or psychiatric hospitalization in the past 6 months

• Recent (past 3 months) change in medications taken for psychiatric reasons

• Current, active suicidal thoughts or suicide attempt within the past year

• Current or past thought disorder or psychosis, or unmanaged bipolar disorder

• Current alcohol/substance use disorder that requires immediate treatment

• Health-related stigma due primarily to mental illness or substance use, or due to health conditions not specified in inclusion criteria.

• No reported internalization of health-related stigma and/or score below pre-specified cutoff on internalized stigma measure

• Unwilling or unable to complete study procedures

Participants with severe progression of disease (e.g., end-of-life) or who are undergoing acute, intensive treatment (such as chemotherapy or radiation therapy) will not be eligible to participate due to expected impacts on HRQOL and greater needs for psychological support than the intervention is intended to provide. Such participants may be eligible after completion of acute treatment or if severe symptoms remit and/or prognosis improves.

Related Conditions & MeSH terms

• Cancer
• Chronic Pain
• Diabetes
• HIV
• Obesity
• Skin Disease
• Skin Diseases

Intervention

Behavioral:
• Healing HEARTS
Session topics will include: psychoeducation; myths and stereotypes; cognitive distortions and restructuring; coping strategies; interpersonal effectiveness; self-efficacy; mindfulness and self-compassion; acceptance and positive self-image; disclosure and finding support; stigma in health care; and empowerment and advocacy.
• Peer Support
Peer support groups will cover general topics such as symptom management, stress, and social support. Stigma will not be a formal topic of discussion, and group leaders will be trained to avoid initiating conversations about stigma; however, to capture realistic discussions in peer support groups, participants will not be prohibited from discussing the topic should they bring it up.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Institute of Mental Health (NIMH), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Internalized Health-Related Stigma Scale	Change score on measure adapted from Internalized Stigma of Mental Illness Scale (scale scores range from 1-7, with higher scores indicating greater internalized stigma)	Baseline to Week 12