Clinical trial NCT05561595: Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
Official title: Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Skin Disease
Cancer
HIV
Diabetes
Chronic Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institutes of Health (NIH)
First posted: 2022-09-30
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This randomized controlled trial (RCT) will test in a sample of 195 patients with high levels of internalized health-related stigma the effects of a novel transdiagnostic intervention designed to help patients cope with this stigma and to reduce its internalization. Participants will be randomly assigned to one of three intervention conditions: (1) a group-based counseling intervention designed to target internalized health-related stigma, delivered virtually (i.e., via telehealth); (2) a general peer support group conducted via telehealth without a targeted stigma intervention; or (3) a waitlist control group. The counseling and peer support conditions will provide 12 weekly group sessions, followed by 2 every other week sessions and 2 monthly sessions (16 sessions total over the course of 26 weeks, or 6 months). Participants across all conditions will complete outcome assessment visits at baseline/randomization, week 12, and week 26. The waitlist control group will receive 12 weeks of the group counseling intervention (condition #1) after completing the week 26 assessment. The primary trial outcome will be the change in internalized stigma from baseline to week 12 (following the most intensive part of the intervention). Change in internalized stigma from baseline to week 26 will be a secondary outcome to determine lasting effects of the intervention in a "maintenance" period with less frequent intervention. Other secondary outcomes will include depression, anxiety, stress, coping, and health-related quality of life (HRQOL)

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.

Primary outcomes:
measure: Change in Internalized Health-Related Stigma Scale score at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change in Internalized Health-Related Stigma Scale score at Week 26
timeFrame: Baseline to Week 26
measure: Change in Internalized Shame Scale score at Week 12
timeFrame: Baseline to Week 12
measure: Change in Internalized Shame Scale score at Week 26
timeFrame: Baseline to Week 26
measure: Change in UCLA Loneliness Scale score at Week 12
timeFrame: Baseline to Week 12
measure: Change in UCLA Loneliness Scale score at Week 26
timeFrame: Baseline to Week 26
measure: Change in Patient Health Questionnaire-9 score at Week 12
timeFrame: Baseline to Week 12
measure: Change in Patient Health Questionnaire-9 score at Week 26
timeFrame: Baseline to Week 26
measure: Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 12
timeFrame: Baseline to Week 12
measure: Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 26
timeFrame: Baseline to Week 26
measure: Change in Severity Measure for Social Anxiety Disorder score at Week 12
timeFrame: Baseline to Week 12
measure: Change in Severity Measure for Social Anxiety Disorder score at Week 26
timeFrame: Baseline to Week 26
measure: Change in 4-item Perceived Stress Scale score at Week 12
timeFrame: Baseline to Week 12
measure: Change in 4-item Perceived Stress Scale score at Week 26
timeFrame: Baseline to Week 26
measure: Change in General Self-Efficacy Scale score at Week 12
timeFrame: Baseline to Week 12
measure: Change in General Self-Efficacy Scale score at Week 26
timeFrame: Baseline to Week 26
measure: Change in Revised Illness Perceptions Questionnaire scores at Week 12
timeFrame: Baseline to Week 12
measure: Change in Revised Illness Perceptions Questionnaire scores at Week 26
timeFrame: Baseline to Week 26
measure: Change in SF-12v2 scores at Week 12
timeFrame: Baseline to Week 12
measure: Change in SF-12v2 scores at Week 26
timeFrame: Baseline to Week 26
measure: Change in CDC Healthy Days Core Measure at Week 12
timeFrame: Baseline to Week 12
measure: Change in CDC Healthy Days Core Measure at Week 26
timeFrame: Baseline to Week 26
Other outcomes:
measure: Change in Brief COPE scores at Week 12
timeFrame: Baseline to Week 12
measure: Change in Brief COPE scores at Week 26
timeFrame: Baseline to Week 26
measure: Change in 6-Item Social Support Questionnaire scores at Week 12
timeFrame: Baseline to Week 12
measure: Change in 6-Item Social Support Questionnaire scores at Week 26
timeFrame: Baseline to Week 26
measure: Treatment Acceptability ratings at Week 12
timeFrame: Week 12
measure: Treatment Acceptability ratings at Week 26
timeFrame: Week 26
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Rebecca Pearl, PhD
role: PRINCIPAL_INVESTIGATOR
References: