NCT05561595 · University of Florida
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
(HEARTS)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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 (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
- 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.
Where
- Gainesville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations