Obesity Clinical Trial
— HEARTSOfficial title:
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Florida | National Institute of Mental Health (NIMH), National Institutes of Health (NIH) |
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 |
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