Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

Last updated: January 14, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Molluscum Contagiosum (Pediatric)

Diabetic Foot Ulcers

Treatment

Peer Support

Healing HEARTS

Clinical Study ID

NCT05561595
IRB202201862
DP2MH132938
PRO00041153
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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-specifiedcutoff 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

Exclusion Criteria:

  • Current or recent (e.g., past 3 months) receipt of psychotherapy or a psychosocialor peer support intervention (exceptions may be made if therapy or support is notfocused on health conditions and is unlikely to affect internalized health-relatedstigma; 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 forpsychiatric 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 tohealth conditions not specified in inclusion criteria.

  • No reported internalization of health-related stigma and/or score belowpre-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.

Study Design

Total Participants: 195
Treatment Group(s): 2
Primary Treatment: Peer Support
Phase:
Study Start date:
October 03, 2024
Estimated Completion Date:
March 31, 2027

Study 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 12 weeks of 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)

Connect with a study center

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

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