Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Healing HEARTS
BehavioralSession 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
BehavioralPeer 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.
Treatment groups
195 Participants
are divided into 3 treatment groupsGroup A: Healing HEARTS InterventionExperimental treatment 1 intervention
Group B: Peer SupportActive comparator 1 intervention
Group C: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change 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 12Secondary outcomes
1
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 262
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 123
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 264
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 12Other outcomes
1
Change in Brief COPE scores at Week 12
Estimated mean change in scores on the following subscales (all with two items rated 1-4, summed to produce scores ranging from 2-8, with higher scores indicating greater use of the respective coping strategy): self-distraction; active coping; denial; substance use; use of emotional support; use of instrumental support; behavioral disengagement; venting; positive reframing; planning; humor; acceptance; religion; and self-blame. Coping strategies may also be analyzed by grouping coping strategies into three broad categories and averaging scores for items within each category: active coping (active coping, positive reframing, planning, humor, acceptance); disengaged coping (self-distraction, denial, substance use, behavioral disengagement, venting, self-blame); and support coping (emotional support, instrumental support, religion).
Time frame
Baseline to Week 122
Change in Brief COPE scores at Week 26
Estimated mean change in scores on the following subscales (all with two items rated 1-4, summed to produce scores ranging from 2-8, with higher scores indicating greater use of the respective coping strategy): self-distraction; active coping; denial; substance use; use of emotional support; use of instrumental support; behavioral disengagement; venting; positive reframing; planning; humor; acceptance; religion; and self-blame. Coping strategies may also be analyzed by grouping coping strategies into three broad categories and averaging scores for items within each category: active coping (active coping, positive reframing, planning, humor, acceptance); disengaged coping (self-distraction, denial, substance use, behavioral disengagement, venting, self-blame); and support coping (emotional support, instrumental support, religion).
Time frame
Baseline to Week 263
Change in 6-Item Social Support Questionnaire scores at Week 12
Estimated mean change scores on two subscales assessing (1) the average number of support persons (N subscale) and (2) the average level of satisfaction with social support (the S subscale, with scores ranging from 1-6, and higher scores indicating greater satisfaction with social support).
Time frame
Baseline to Week 124
Change in 6-Item Social Support Questionnaire scores at Week 26
Estimated mean change scores on two subscales assessing (1) the average number of support persons (N subscale) and (2) the average level of satisfaction with social support (the S subscale, with scores ranging from 1-6, and higher scores indicating greater satisfaction with social support).
Time frame
Baseline to Week 26Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov