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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
195
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 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.
University of Florida
Gainesville, Florida, United States
RECRUITINGChange in Internalized Health-Related Stigma Scale score at 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.
Time frame: Baseline to Week 12
Change in Internalized Health-Related Stigma Scale score at 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.
Time frame: Baseline to Week 26
Change in Internalized Shame Scale score at 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).
Time frame: Baseline to Week 12
Change in Internalized Shame Scale score at 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).
Time frame: Baseline to Week 26
Change in UCLA Loneliness Scale score at Week 12
Estimated mean change score, with summed scores ranging from 20-80 (higher scores indicate greater loneliness/isolation).
Time frame: Baseline to Week 12
Change in UCLA Loneliness Scale score at Week 26
Estimated mean change score, with summed scores ranging from 20-80 (higher scores indicate greater loneliness/isolation).
Time frame: Baseline to Week 26
Change in Patient Health Questionnaire-9 score at Week 12
Estimated mean change score, with summed scores ranging from 0-27 (higher scores indicate greater severity of depression symptoms).
Time frame: Baseline to Week 12
Change in Patient Health Questionnaire-9 score at Week 26
Estimated mean change score, with summed scores ranging from 0-27 (higher scores indicate greater severity of depression symptoms).
Time frame: Baseline to Week 26
Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 12
Estimated mean change score, with summed scores ranging from 0-21 (higher scores indicate greater severity of generalized anxiety).
Time frame: Baseline to Week 12
Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 26
Estimated mean change score, with summed scores ranging from 0-21 (higher scores indicate greater severity of generalized anxiety).
Time frame: Baseline to Week 26
Change in Severity Measure for Social Anxiety Disorder score at Week 12
Estimated mean change score, with summed scores ranging from 0-40 (higher scores indicate greater severity of social anxiety).
Time frame: Baseline to Week 12
Change in Severity Measure for Social Anxiety Disorder score at Week 26
Estimated mean change score, with summed scores ranging from 0-40 (higher scores indicate greater severity of social anxiety).
Time frame: Baseline to Week 26
Change in 4-item Perceived Stress Scale score at Week 12
Estimated mean change score, with summed scores ranging from 0-16 (higher scores indicate greater perceived stress).
Time frame: Baseline to Week 12
Change in 4-item Perceived Stress Scale score at Week 26
Estimated mean change score, with summed scores ranging from 0-16 (higher scores indicate greater perceived stress).
Time frame: Baseline to Week 26
Change in General Self-Efficacy Scale score at Week 12
Estimated mean change score, with summed scores ranging from 10-40 (higher scores indicate greater self-efficacy).
Time frame: Baseline to Week 12
Change in General Self-Efficacy Scale score at Week 26
Estimated mean change score, with summed scores ranging from 10-40 (higher scores indicate greater self-efficacy).
Time frame: Baseline to Week 26
Change in Revised Illness Perceptions Questionnaire scores at 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.
Time frame: Baseline to Week 12
Change in Revised Illness Perceptions Questionnaire scores at 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.
Time frame: Baseline to Week 26
Change in SF-12v2 scores at 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).
Time frame: Baseline to Week 12
Change in SF-12v2 scores at 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).
Time frame: Baseline to Week 26
Change in CDC Healthy Days Core Measure at 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).
Time frame: Baseline to Week 12
Change in CDC Healthy Days Core Measure at 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).
Time frame: Baseline to Week 26
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