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Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

Study acronym: HEARTS
StatusActive, Not Recruiting
PhaseNot applicable
Started2024-10-03
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
Enrollment closed, study ongoing
2026-07-23
Study Status, Eligibility v8
Completion pushed: 2027-03-31 → 2027-06-30
Eligibility criteria+40 characters
Inclusion Criteria: Age 18 years or older Currently residing in the United States At least one of the following stigmatized health conditions: [...]
2026-02-04
Study Status v7
Re-verified, no change to tracked fields
2025-01-14
Study Status, Eligibility v6
Eligibility criteria-30 characters
[...] re on internalized stigma measure and confirmed by interview during screening Participants must have availability to attend weekly virtua [...] re below pre-specified cutoff on internalized stigma measure at screening Unwilling or unable to complete study procedures Participan [...]
2025-01-03
Study Status, Arms and Interventions, Outcome Measures, Eligibility v5
Eligibility criteria+264 characters
[...] re on internalized stigma measure and confirmed by interview during screening Participants must have availability to attend weekly virtua [...] itate 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 psychiatricsupport 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, approxima [...] [...]
Secondary endpoints19 to 21 entries
Change in Internalized Health-Related Stigma Scale score at Week 26 Change in General Self-Efficacy Scale score at Week 12 Change in General Self-Efficacy Scale score at Week 26
Primary endpoints1 entry, revised
Change in Internalized Health-Related Stigma Scale score at Week 12
Show 4 earlier versions
2024-10-22
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-15→confirmed 2024-10-03
Study sites0→1
Eligibility criteriarevised
Inclusion Criteria: Age 18 years or older At least one of the following stigmatized health conditions: Obesity (definedor by ahigh body massweight indexthat ofnegatively 30affects kg/m2 or higherhealth) Skin disease (including but not limited to psoriasis, ecze [...]
Secondary endpoints+1,095 characters
Change in Internalized Health-Related Stigma Scale at Week 26 Change in Internalized Shame Scale score at Week 12 Change in Internalized Shame Scale score at Week 26 Change in UCLA Loneliness Scale score at Week 12 Change in UCLA Loneliness Scale score at Week 26 Change in Patient Health Questionnai [...]
Primary endpoints1 entry, revised
Change in Internalized Health-Related Stigma Scale at Week 12
Study description+13 characters
[...] eek 12, and week 26. The waitlist control group will receive 12 weeks of the group counseling intervention (condition #1) after comp [...] tcome to determine lasting effects of the intervention in a "maintenance" period with less frequent intervention. Other s [...]
Collaborators2 entries, reordered
2024-05-09
Study Status, Eligibility v3
Primary completion date2026-11-30→2026-12-31
Completion date2027-02-28→2027-03-31
Start date2024-03-01→2024-10-15
Eligibility criteria-1 characters
Inclusion Criteria: Age 18 years or older OneAt orleast moreone of the following stigmatized health conditions: Obesity (de [...] ls in remission) HIV Type 1 or type 2 diabetes Chronic pain Reported perceptions of stigma due to health condition (by interview) Reported internalization of health-related stigma, as determined by a pre-specified cutoff score of or above the midpoint on internalized stigma measure and confirmed by interview P [...] ention, or psychiatric hospitalization in the past 6 months Recent (past 3 months) change in medications taken for psychiatric reasons Current, active suicidal though [...] [...]
2023-11-13
Study Status, Outcome Measures, Eligibility v2
Primary completion date2026-11→2026-11-30
Completion date2027-02→2027-02-28
Start date2024-03→2024-03-01
Eligibility criteria+57 characters
Inclusion Criteria: Age 18 years or older One or more 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, eczem [...] vical, colorectal, gynecologic, prostate, or head and neck; may includeincluding individuals in remission) HIV Type 1 or type 2 diabetes Chr [...] lization of health-related stigma, as determined by a score of or above the midpoint on internalized stigma measure and confir [...]
2022-10-05
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v1
Primary completion date2025-08-31→2026-11
Completion date2025-08-31→2027-02
Start date2022-10→2024-03
Enrollment target1218→195
Study arms2→3
InterventionsCounseling Intervention (Behavioral), Peer Support (Behavioral)→Healing HEARTS (Behavioral), Peer Support (Behavioral)
Eligibility criteria+1,311 characters
[...] ervical, colorectal, gynecologic, prostate, or head and neck; may include individuals in remission) HIV Type 1 or type 2 diabetes Chronic pain Reported percep [...] t 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 grou [...] Exclusion Criteria: Current or recent (past 3 months) receip [...] psychotherapy or a psy [...]
Collaborators1 to 2 entries
National Institute of Mental Health (NIMH)
Study title-9 characters
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma (HEARTS)
2022-09-27
Original filing
University of Florida
325 trials monitored
See 23 trials at risk
Diabetes
4,247 trials monitored
See 176 trials at risk
Obesity
3,523 trials monitored
See 133 trials at risk
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.
Trial Details
NCT Number NCT05561595
Lead Sponsor University of Florida
Collaborators: National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
Conditions Obesity, Skin Disease, Cancer, HIV, Diabetes, Chronic Pain
Enrollment 195 participants
Start Date 2024-10-03
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-16