Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

Not Applicable

Recruiting

• Conditions: Cancer; HIV; Chronic Pain; Obesity; Diabetes; Skin Disease
• Interventions: Behavioral: Healing HEARTS; Behavioral: Peer Support

• Registration Number: NCT05561595
• Lead Sponsor: University of Florida

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)

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2024-10-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 195

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healing HEARTS Intervention	Healing HEARTS	The Healing Health-Related Stigma (Healing HEARTS) intervention will provide group telehealth sessions adapted from prior disease-specific interventions for internalized stigma and from standard techniques and structures used in evidence-based cognitive-behavioral therapies. Fifty-minute sessions will be delivered weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. Handouts and homework assignments will be used as part of the group meetings. All group sessions will be conducted remotely using telehealth technology.
Peer Support	Peer Support	The peer support condition will provide group telehealth sessions without any tailored stigma content. Group sessions will be 50 minutes and will meet weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. All group sessions will be conducted remotely using telehealth technology.

Primary Outcome Measures

Name	Time	Method
Change in Internalized Health-Related Stigma Scale score at Week 12	Baseline 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.

Secondary Outcome Measures

Name	Time	Method
Change in Internalized Health-Related Stigma Scale score at Week 26	Baseline to Week 26	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.
Change in Internalized Shame Scale score at Week 12	Baseline to Week 12	Estimated mean change score for two subscales: Shame (summed scores range from 0-96, higher scores indicate greater shame) and Self-Esteem (summed scores range from 0-24, higher scores indicate higher self-esteem).
Change in Internalized Shame Scale score at Week 26	Baseline to Week 26	Estimated mean change score for two subscales: Shame (summed scores range from 0-96, higher scores indicate greater shame) and Self-Esteem (summed scores range from 0-24, higher scores indicate higher self-esteem).
Change in UCLA Loneliness Scale score at Week 12	Baseline to Week 12	Estimated mean change score, with summed scores ranging from 20-80 (higher scores indicate greater loneliness/isolation).
Change in UCLA Loneliness Scale score at Week 26	Baseline to Week 26	Estimated mean change score, with summed scores ranging from 20-80 (higher scores indicate greater loneliness/isolation).
Change in Patient Health Questionnaire-9 score at Week 12	Baseline to Week 12	Estimated mean change score, with summed scores ranging from 0-27 (higher scores indicate greater severity of depression symptoms).
Change in Patient Health Questionnaire-9 score at Week 26	Baseline to Week 26	Estimated mean change score, with summed scores ranging from 0-27 (higher scores indicate greater severity of depression symptoms).
Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 12	Baseline to Week 12	Estimated mean change score, with summed scores ranging from 0-21 (higher scores indicate greater severity of generalized anxiety).
Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 26	Baseline to Week 26	Estimated mean change score, with summed scores ranging from 0-21 (higher scores indicate greater severity of generalized anxiety).
Change in Severity Measure for Social Anxiety Disorder score at Week 12	Baseline to Week 12	Estimated mean change score, with summed scores ranging from 0-40 (higher scores indicate greater severity of social anxiety).
Change in Severity Measure for Social Anxiety Disorder score at Week 26	Baseline to Week 26	Estimated mean change score, with summed scores ranging from 0-40 (higher scores indicate greater severity of social anxiety).
Change in 4-item Perceived Stress Scale score at Week 12	Baseline to Week 12	Estimated mean change score, with summed scores ranging from 0-16 (higher scores indicate greater perceived stress).
Change in 4-item Perceived Stress Scale score at Week 26	Baseline to Week 26	Estimated mean change score, with summed scores ranging from 0-16 (higher scores indicate greater perceived stress).
Change in General Self-Efficacy Scale score at Week 12	Baseline to Week 12	Estimated mean change score, with summed scores ranging from 10-40 (higher scores indicate greater self-efficacy).
Change in General Self-Efficacy Scale score at Week 26	Baseline to Week 26	Estimated mean change score, with summed scores ranging from 10-40 (higher scores indicate greater self-efficacy).
Change in Revised Illness Perceptions Questionnaire scores at Week 12	Baseline to Week 12	Estimated mean change scores on four subscales: Consequences, Personal Control, Illness Coherence, and Emotional Representations. Scores for each subscale are averaged, with ratings ranging from 1-5, and higher scores Indicating greater perceived consequences, control, understanding, and emotional impacts of health conditions, respectively.
Change in Revised Illness Perceptions Questionnaire scores at Week 26	Baseline to Week 26	Estimated mean change scores on four subscales: Consequences, Personal Control, Illness Coherence, and Emotional Representations. Scores for each subscale are averaged, with ratings ranging from 1-5, and higher scores Indicating greater perceived consequences, control, understanding, and emotional impacts of health conditions, respectively.
Change in SF-12v2 scores at Week 12	Baseline to Week 12	Estimated mean change scores in mental and physical health component t-scores, with a population mean score of 50 and standard deviation of 10 (higher scores indicate better mental and physical health-related quality of life, respectively).
Change in SF-12v2 scores at Week 26	Baseline to Week 26	Estimated mean change scores in mental and physical health component t-scores, with a population mean score of 50 and standard deviation of 10 (higher scores indicate better mental and physical health-related quality of life, respectively).
Change in CDC Healthy Days Core Measure at Week 12	Baseline to Week 12	Estimated mean change scores in items assessing the number of unhealthy days due to physical and mental health, respectively (range 0-30 days), the number of days of impairment due to poor health (0-30 days), and an unhealthy days index score of total combined physically and mentally unhealthy days (0-30 days).
Change in CDC Healthy Days Core Measure at Week 26	Baseline to Week 26	Estimated mean change scores in items assessing the number of unhealthy days due to physical and mental health, respectively (range 0-30 days), the number of days of impairment due to poor health (0-30 days), and an unhealthy days index score of total combined physically and mentally unhealthy days (0-30 days).

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States