Clinical trial

Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

Recruiting now · Not applicable · 1 countries · Registry ID NCT05561595

Recruiting nowNot applicableInterventional

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. 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Skin Disease, Cancer, HIV, Diabetes, Chronic Pain

Full registry criteria

Inclusion Criteria: * Age 18 years or older * Currently residing in the United States * 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.

Treatments and study arms

Healing HEARTS

Behavioral

Session topics will include: psychoeducation; myths and stereotypes; cognitive distortions and restructuring; coping strategies; interpersonal effectiveness; self-efficacy; mindfulness and self-compassion; acceptance and positive self-image; disclosure and finding support; stigma in health care; and empowerment and advocacy.

Peer Support

Behavioral

Peer support groups will cover general topics such as symptom management, stress, and social support. Stigma will not be a formal topic of discussion, and group leaders will be trained to avoid initiating conversations about stigma; however, to capture realistic discussions in peer support groups, participants will not be prohibited from discussing the topic should they bring it up.

Primary outcomes

Change in Internalized Health-Related Stigma Scale score at Week 12Baseline to Week 12

Estimated mean change score for the total scale (primary outcome) and three subscales (Perceived and Anticipated Stigma, Stereotype Application and Self-Devaluation, and Stigma Resistance); scale scores are averaged and range from 1-7, with higher scores indicating greater internalized health-related stigma.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Florida🇺🇸 Gainesville, Florida, United States
Rebecca Pearl, PhDContact
Study contactContact