Group counseling to reduce health-related stigma
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
This study is testing a new group counseling program to see if it can help people with conditions like obesity, skin diseases, cancer, HIV, and diabetes feel better about themselves and reduce feelings of stigma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05561595 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests a novel group counseling intervention aimed at reducing internalized health-related stigma among patients with conditions such as obesity, skin diseases, cancer, HIV, and diabetes. Participants will be randomly assigned to one of three groups: a targeted counseling intervention, a general peer support group, or a waitlist control group. The intervention will consist of 12 weekly sessions delivered virtually, followed by additional sessions over a 26-week period. The primary outcome will measure changes in internalized stigma, while secondary outcomes will assess mental health indicators like depression and anxiety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific stigmatized health conditions and reported internalization of health-related stigma.
Not a fit: Patients without a stigmatized health condition or those unable to participate in virtual group meetings may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients by reducing the stigma associated with their health conditions.
How similar studies have performed: While the approach is innovative, similar interventions targeting health-related stigma have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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-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 this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Pearl, PhD — University of Florida
- Study coordinator: Rebecca Pearl, PhD
- Email: rebecca.pearl@phhp.ufl.edu
- Phone: 352-294-5405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.