Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2025-12-24 @ 1:52 PM
NCT ID:
NCT05561595
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05561595
Study Brief:
Protocol Section:
NCT05561595