Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

NCT05561595 | Recruiting DMC

• 3 other identifiers: IRB202201862DP2MH132938PRO00041153
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Skin Disease; Cancer; HIV; Diabetes; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Internalized Health-Related Stigma Scale score at Week 12

  Estimated mean change score for the total scale (primary outcome) and three subscales (Perceived and Anticipated Stigma, Stereotype Application and Self-Devaluation, and Stigma Resistance); scale scores are averaged and range from 1-7, with higher scores indicating greater internalized health-related stigma.

  Baseline to Week 12

Secondary Outcomes (21)

• Change in Internalized Health-Related Stigma Scale score at Week 26

  Baseline to Week 26

• Change in Internalized Shame Scale score at Week 12

  Baseline to Week 12

• Change in Internalized Shame Scale score at Week 26

  Baseline to Week 26

• Change in UCLA Loneliness Scale score at Week 12

  Baseline to Week 12

• Change in UCLA Loneliness Scale score at Week 26

  Baseline to Week 26

Other Outcomes (6)

• Change in Brief COPE scores at Week 12

  Baseline to Week 12

• Change in Brief COPE scores at Week 26

  Baseline to Week 26

• Change in 6-Item Social Support Questionnaire scores at Week 12

  Baseline to Week 12

Study Arms (3)

Healing HEARTS Intervention

EXPERIMENTAL

The Healing Health-Related Stigma (Healing HEARTS) intervention will provide group telehealth sessions adapted from prior disease-specific interventions for internalized stigma and from standard techniques and structures used in evidence-based cognitive-behavioral therapies. Fifty-minute sessions will be delivered weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of approximately 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. Handouts and homework assignments will be used as part of the group meetings. All group sessions will be conducted remotely using telehealth technology.

Behavioral: Healing HEARTS

Peer Support

ACTIVE COMPARATOR

The peer support condition will provide group telehealth sessions without any tailored stigma content. Group sessions will be 50 minutes and will meet weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of approximately 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. All group sessions will be conducted remotely using telehealth technology.

Behavioral: Peer Support

Waitlist Control

NO INTERVENTION

The waitlist control group will not receive any active intervention until after completing week 12 and week 26 assessments. Participants will receive periodical updates and reminders from study staff to enhance retention. After assessments are completed, participants will be provided with 12 weeks of the Healing HEARTS intervention.

Interventions

Healing HEARTS BEHAVIORAL

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.

Healing HEARTS Intervention

Peer Support BEHAVIORAL

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.

Peer Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• At least one of the following stigmatized health conditions:
• Obesity (or high body weight that negatively affects health)
• 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.

You may not qualify if:

• Current or recent (e.g., past 3 months) receipt of psychotherapy or a psychosocial or peer support intervention (exceptions may be made if therapy or support is not focused on health conditions and is unlikely to affect internalized health-related stigma; e.g., family or marriage counseling, religious study groups, etc.)
• Psychiatric hospitalization in the past 6 months
• Recent (e.g., past 3 months, approximately) 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
• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Mental Health (NIMH): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Skin Diseases; Neoplasms; Diabetes Mellitus; Chronic Pain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pain; Neurologic Manifestations

Study Officials

• Rebecca Pearl, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Pearl, PhD

CONTACT

352-294-5405; rebecca.pearl@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: October 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates of January 15th and July 15th.

Locations

US (1)