Group Counseling + Peer Support for Health-Related Stigma
(HEARTS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Disqualifiers: Psychotherapy, Psychiatric hospitalization, Thought disorder, others
No Placebo Group
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. However, if you have recently changed medications for psychiatric reasons, you may not be eligible to participate.
What data supports the effectiveness of the treatment Group Counseling + Peer Support for Health-Related Stigma?
Research shows that group therapy and peer support can help people with mental health conditions like schizophrenia and depression cope with stigma and feel more empowered. This suggests that similar approaches might be effective for other health-related stigmas as well.
12345Is group counseling and peer support safe for participants?
The research does not specifically address safety concerns, but group counseling and peer support interventions are generally considered safe as they focus on reducing stigma and promoting positive attitudes without involving physical risks.
678910How is the Group Counseling + Peer Support treatment for health-related stigma different from other treatments?
This treatment is unique because it combines group counseling with peer support, leveraging personal experiences and relationships to address stigma, which is not commonly emphasized in other treatments. It focuses on building supportive communities and personal connections, which can be particularly effective in reducing stigma and improving mental health.
1112131415Eligibility Criteria
This trial is for adults over 18 with conditions like obesity, skin diseases, cancer (including those in remission), diabetes, or chronic pain who feel stigmatized because of their health. They must recognize this stigma and be able to attend virtual group meetings regularly for 6 months.Inclusion Criteria
Willingness to actively participate and share information about themselves in the group meetings
I am 18 years old or older.
Ability to read, comprehend, and speak English in order to participate in group sessions and complete study questionnaires
+3 more
Exclusion Criteria
No reported internalization of health-related stigma and/or score below pre-specified cutoff on internalized stigma measure
I have recently been in psychotherapy, support groups, or psychiatric care.
I have changed my psychiatric medications in the last 3 months.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive group telehealth sessions for 12 weeks, followed by 2 every-other-week sessions and 2 monthly sessions
26 weeks
16 sessions (virtual)
Follow-up
Participants are monitored for changes in internalized stigma and other outcomes
4 weeks
Waitlist Control Intervention
Waitlist control group receives 12 weeks of the group counseling intervention after completing the week 26 assessment
12 weeks
Participant Groups
The study tests a new counseling program called Healing HEARTS alongside peer support. It aims to help patients deal with the shame they might feel about their illness by talking in groups and supporting each other to improve mental health and life quality.
3Treatment groups
Experimental Treatment
Active Control
Group I: Healing HEARTS InterventionExperimental Treatment1 Intervention
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 approximately 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.
Group II: Peer SupportActive Control1 Intervention
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 approximately 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.
Group III: Waitlist ControlActive Control1 Intervention
The waitlist control group will not receive any active intervention until after completing week 12 and week 26 assessments. Participants will receive periodical updates and reminders from study staff to enhance retention. After assessments are completed, participants will be provided with 12 weeks of the Healing HEARTS intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
National Institutes of Health (NIH)Collaborator
References
The impact of education on attitudes toward medical cannabis. [2023]This research explores the impact of patient education on reducing historical and current stigma.
Promoting stigma coping and empowerment in patients with schizophrenia and depression: results of a cluster-RCT. [2021]There is a need for interventions supporting patients with mental health conditions in coping with stigma and discrimination. A psycho-educational group therapy module to promote stigma coping and empowerment (STEM) was developed and tested for efficacy in patients with schizophrenia or depression. 30 clinical centers participated in a cluster-randomized clinical trial, representing a broad spectrum of mental health care settings: in-patient (acute treatment, rehabilitation), out-patient, and day-hospitals. As randomized, patients in the intervention group clusters/centers received an illness-specific eight sessions standard psychoeducational group therapy plus three specific sessions on stigma coping and empowerment ('STEM'). In the control group clusters the same standard psychoeducational group therapy was extended to 11 sessions followed by one booster session in both conditions. In total, N = 462 patients were included in the analysis (N = 117 with schizophrenia spectrum disorders, ICD-10 F2x; N = 345 with depression, ICD-10 F31.3-F31.5, F32-F34, and F43.2). Clinical and stigma-related measures were assessed before and directly after treatment, as well as after 6 weeks, 6 months, and 12 months (M12). Primary outcome was improvement in quality of life (QoL) assessed with the WHO-QOL-BREF between pre-assessment and M12 analyzed by mixed models and adjusted for pre-treatment differences. Overall, QoL and secondary outcome measures (symptoms, functioning, compliance, internalized stigma, self-esteem, empowerment) improved significantly, but there was no significant difference between intervention and control group. The short STEM module has proven its practicability as an add-on in different settings in routine mental health care. The overall increase in empowerment in both, schizophrenia and depression, indicates patients' treatment benefit. However, factors contributing to improvement need to be explored.The study has been registered in the following trial registers. ClinicalTrials.gov: https://register.clinicaltrials.gov/ Registration number: NCT01655368. DRKS: https://www.drks.de/drks_web/ Registration number: DRKS00004217.
Stigma in health facilities: why it matters and how we can change it. [2023]Stigma in health facilities undermines diagnosis, treatment, and successful health outcomes. Addressing stigma is fundamental to delivering quality healthcare and achieving optimal health. This correspondence article seeks to assess how developments over the past 5 years have contributed to the state of programmatic knowledge-both approaches and methods-regarding interventions to reduce stigma in health facilities, and explores the potential to concurrently address multiple health condition stigmas. It is supported by findings from a systematic review of published articles indexed in PubMed, Psychinfo and Web of Science, and in the United States Agency for International Development's Development Experience Clearinghouse, which was conducted in February 2018 and restricted to the past 5 years. Forty-two studies met inclusion criteria and provided insight on interventions to reduce HIV, mental illness, or substance abuse stigma. Multiple common approaches to address stigma in health facilities emerged, which were implemented in a variety of ways. The literature search identified key gaps including a dearth of stigma reduction interventions in health facilities that focus on tuberculosis, diabetes, leprosy, or cancer; target multiple cadres of staff or multiple ecological levels; leverage interactive technology; or address stigma experienced by health workers. Preliminary results from ongoing innovative responses to these gaps are also described.The current evidence base of stigma reduction in health facilities provides a solid foundation to develop and implement interventions. However, gaps exist and merit further work. Future investment in health facility stigma reduction should prioritize the involvement of clients living with the stigmatized condition or behavior and health workers living with stigmatized conditions and should address both individual and structural level stigma.
Reducing depression stigma using a web-based program. [2022]This study was designed to investigate the efficacy and feasibility of a web-based depression stigma education tool for healthcare professionals.
Ending self-stigma: pilot evaluation of a new intervention to reduce internalized stigma among people with mental illnesses. [2022]This study evaluated "Ending Self-Stigma" (ESS), a structured 9-session group intervention to help people with serious mental illnesses reduce internalized stigma.
Characterizing suicide-related self-disclosure by peer specialists: a qualitative analysis of audio-recorded sessions. [2023]We characterized peer support specialists' self-disclosures related to suicide and recipient responses to inform services for high-risk individuals that may include peer support.
The effects of group counseling and self-affirmation on stigma and group relationship development: A replication and extension. [2023]The stigma of seeking counseling and negative attitudes about counseling are primary barriers to its use. In the only known study examining the utility of attending a group counseling session to ameliorate stigma (no control group), participation was associated with reductions in self-stigma (Wade et al., 2011). Self-affirmation interventions have shown promising results in reducing stigma and promoting positive expectations about counseling, but no research has examined its effects on a counseling session. In the present, two-part study, 172 college students who had previously completed an online screening survey, including measures of stigma, participated in a single session of group counseling at a mental health clinic. Upon arrival, participants completed a self-affirmation intervention before viewing psychoeducation (n = 66; 12 groups) or only viewed psychoeducation (n = 72; 14 groups); both groups then completed a session of group counseling. After, participants completed these same measures along with measures of group relationships. The remaining participants (n = 34; 7 groups) viewed psychoeducation and completed the same stigma measures before being informed of randomization to the wait-list control condition. Our results replicate and extend findings from Wade et al. (2011): Completing a single session of group counseling reduced self-stigma and promoted positive attitudes toward counseling. Further, completing self-affirmation reduced postsession perceptions of public stigma. Self-affirmation had no impact on group relationships. Overall, findings suggest the utility of offering a "try-out" session of group counseling as a stigma-reduction intervention; preceding with a brief self-affirmation intervention provides further benefits by reducing perceptions of public stigma. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
Provider Opinions Regarding the Development of a Stigma-Reduction Intervention Tailored for Providers. [2022]Interventions involving contact with a person who has recovered from mental illness are most effective at reducing stigma. This study sought input from health care providers to inform the design of a contact intervention intended to reduce provider stigma toward persons with serious mental illness. Using a purposive sampling strategy, data were collected from providers at five Veterans Affairs hospitals in the southeastern United States. Seven focus groups were conducted, and 83 health care providers participated. A semistructured interview guide was used to elicit providers' opinions about the target group of a contact intervention for providers, what providers would consider a credible contact, the preferred format for delivery, the usefulness of potentially tailoring the intervention to a specific facility, and how to measure change in clinical behaviors. Focus group data were analyzed using rapid data analysis techniques. Participants uniformly recommended a broad target audience for the stigma-reduction intervention, including all primary care and specialist providers. They suggested that the person providing the "lived experience" for the contact intervention should be either a health care provider or a patient with serious mental illness. Face-to-face presentation was favored, but video presentation was considered more feasible. Participants stated that information about local disparities in care rendered to patients with or without mental illness would convince providers of how stigma may be a contributing factor to these disparities. Multiple training opportunities were favored, while mandatory training was disliked. Standard stigma-reduction interventions with subgroups of the general public (e.g., providers) may need to be modified for optimum subgroup effectiveness.
Changing stigma through a consumer-based stigma reduction program. [2021]This study assessed the Anti-Stigma Project workshop, a contact/education intervention developed by On Our Own of Maryland, Inc. and the Maryland Mental Hygiene Administration. Two separate randomized controlled trials administered pre- and post-test questionnaire assessments. One included people with mental illness (N = 127) and a second included mental health providers (N = 131). Post-intervention, people with mental illness were more aware of stigma, had lower levels of prejudice, and increased belief in recovery. Providers were more aware of stigma, had lower levels of prejudice, and increased concurrence in self-determination of people with mental illness. Increasing providers' stigma awareness and recognition can promote higher quality service delivery. Increasing stigma awareness and recognition for people with mental illness can foster confidence in overcoming psychiatric disabilities. Using a participatory action research team, our protocol included extant and newly developed stigma change tools. Organizations seeking to conduct effective evaluation studies should consider collaborative processes including the expertise of affected constituents.
The California Assessment of Stigma Change: A Short Battery to Measure Improvements in the Public Stigma of Mental Illness. [2019]Contact-based anti-stigma programs delivered by people with lived experience yields stigma change. This study examined psychometrics and sensitivity of the California Assessment of Stigma Change (CASC). CASC assesses prejudicial beliefs, affirming attitudes, and willingness to seek mental healthcare. Four samples, two high school groups, college students, and hotel desk clerks, completed CASC immediately before and after a contact-based program. Two samples completed follow-up: one of the high school groups and the college students. CASC assesses stigma with a 9-item Attribution Questionnaire (AQ9), personal empowerment with a 3-item scale (ES), recovery orientation with a 3-item scale (RS), and psychological help seeking willingness with a 6-item questionnaire (CSQ). Internal consistencies ranged adequate to satisfactory for AQ9, ES, and CSQ. Concurrent validity was partially supported. Change sensitivity was demonstrated among at least half of each construct's analyses. CASC seems a psychometrically valid way to efficiently monitor attitudinal and care seeking intentions changes. Outcome monitoring can strengthen contact-based anti-stigma programs, an emerging evidence-based practice.
SafeTalk: Training Peers to Deliver a Motivational Interviewing HIV Prevention Program. [2022]As multiple effective interventions emerge to reduce the spread of HIV, there is a need to implement and disseminate such programs cost-effectively, such as by expanding service delivery through integration of peer supporters. The benefits of peer support are well established. However, knowledge about peer counseling initiatives remain limited. This pilot study tested the feasibility, fidelity, and acceptability of a motivational interviewing (MI) counseling training with individuals living with HIV to serve as peer counselors in order to address medication adherence and safer sex. We adapted, SafeTalk, an evidence-based intervention previously delivered by health professionals to reduce risky sexual behaviors among people living with HIV. We trained six peers in a 5-day program (24 hours total) over a 2-month period. We used a combination of training observation, pre-and posttests, debriefing, and the Motivational Interviewing Treatment Integrity (MITI 3.1) scale 3.1 to assess implementation of the training. Results suggest the program was feasible, and there was positive acceptability. However, fidelity to MI was poor. While participants were dedicated and enthusiastic about the training and able to learn some skills and demonstrate the "spirit of MI," they had difficulty with reflecting and moving away from giving direct advice. Training challenges and successes are discussed.
Facilitating support groups for professionals working with people with AIDS. [2007]Social workers, nurses, and other health care professionals who work with people with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) are experiencing burnout from the excessive demands on their energy, strength, and resources. Support groups, with their focus on awareness, shared experiences, supportive and helping relationships, and the emotional consequences of working with people with AIDS, help health care professionals manage stress and enhance their capacity and effectiveness to work with these clients. In addition, support groups help participants feel less isolated and share feelings regarding such difficult issues as death, anger, helplessness, and loss. The use of this type of group work is identified, including its administration, effective intervention techniques, and issues of health care professionals who work with the HIV/AIDS epidemic. Problems related to group membership and dropout rates are explored as unresolved issues.
Embodied work: insider perspectives on the work of HIV/AIDS peer counselors. [2021]Our aim in this study was to explore HIV/AIDS peer counseling from the perspective of women actively engaged in this work within the context of a community-based program in rural areas of the southeastern United States. Based on this research we suggest that the embodied work of HIV/AIDS peer counselors is constructed around their personal identities and experiences. This work involves gaining entry to other HIV-positive women's lives, building relationships, drawing on personal experiences, facing issues of fear and stigma, tailoring peer counseling for diversity, balancing risks and benefits, and terminating relationships. Peer counselors recognize the personal and collective value of their work, which, like much of women's work within the context of family and community, lacks public visibility and acknowledgment. We discuss implications for the training and support of peer-based interventions for HIV and other women's health issues across diverse contexts and settings.
Evaluation of a peer support group therapy for HIV-infected adolescents. [2019]To assess the effects of a peer support group therapy on HIV-infected adolescents.
'Management of a spoiled identity': systematic review of interventions to address self-stigma among people living with and affected by HIV. [2022]Self-stigma, also known as internalised stigma, is a global public health threat because it keeps people from accessing HIV and other health services. By hampering HIV testing, treatment and prevention, self-stigma can compromise the sustainability of health interventions and have serious epidemiological consequences. This review synthesised existing evidence of interventions aiming to reduce self-stigma experienced by people living with HIV and key populations affected by HIV in low-income and middle-income countries.