Group Counseling + Peer Support for Health-Related Stigma

(HEARTS Trial)

Overseen By Rebecca Pearl, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Psychotherapy, Psychiatric hospitalization, Thought disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 26 weeks

195 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people manage the stigma associated with certain health conditions, such as obesity, skin diseases, cancer, HIV, diabetes, or chronic pain. It will test two approaches: a group counseling program called Healing HEARTS and a peer support group, both conducted through online sessions. The goal is to identify the most effective method to reduce internalized stigma and improve quality of life. Individuals who feel judged or ashamed due to their health condition and are willing to join online group meetings may find this trial suitable. As an unphased trial, this study offers a unique opportunity to explore supportive interventions that could enhance emotional well-being and 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 prior data suggests that these interventions are safe for participants?

Research has shown that group counseling and peer support programs, such as the Healing HEARTS program, are generally safe and well-received. Studies have found that peer-led programs can reduce feelings of stigma and enhance recovery and confidence without causing major side effects. Participants often feel better about themselves and their conditions while experiencing fewer negative effects.

The Healing HEARTS program includes group telehealth sessions led by trained professionals, building on these safe practices. The sessions use techniques from cognitive-behavioral therapies, which are widely used and considered safe for mental health support. Since these focus on counseling and support rather than medication, the risk of physical side effects remains low.

Overall, evidence suggests that joining group counseling and peer support programs can safely address health-related stigma and improve mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Group Counseling + Peer Support approach for tackling health-related stigma because it combines innovative elements like the Healing HEARTS intervention with traditional peer support. Healing HEARTS is unique in that it adapts cognitive-behavioral therapy techniques specifically to address internalized stigma, which is a fresh take on mental health interventions. By delivering these sessions via telehealth, the treatment offers a flexible and accessible way for individuals to participate, making it easier for people who might otherwise face barriers to attending in-person sessions. Additionally, the structure of the intervention, with a mix of weekly, bi-weekly, and monthly sessions, is designed to provide consistent support and foster long-term change. Overall, this multifaceted approach could offer a more comprehensive solution compared to standard peer support, which typically lacks targeted stigma reduction content.

What evidence suggests that this trial's treatments could be effective for reducing health-related stigma?

Research has shown that group counseling programs like the Healing HEARTS program, one of the interventions in this trial, can reduce negative feelings about health conditions. These programs use cognitive-behavioral therapy techniques, which have been proven to improve mental health by altering negative thought patterns. Studies have found that another intervention in this trial, peer support, helps lessen negative feelings and enhances a sense of recovery and empowerment. While peer support alone might not significantly boost hope or empowerment, it still contributes to overall recovery. This trial will compare the effects of the Healing HEARTS program and peer support, with the potential that combining counseling with peer support could offer a comprehensive approach to addressing stigma and improving quality of life. ^{1 6 7 8 9}

Who Is on the Research Team?

Rebecca Pearl, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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 have a device with internet for the study or need one provided.

I have a health condition like obesity, skin disease, cancer, HIV, diabetes, or chronic pain and feel stigmatized because of it.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Counseling Intervention
• Healing HEARTS
• Peer Support

Trial Overview 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.

How Is the Trial Designed?

Group I: Healing HEARTS Intervention Experimental Treatment 1 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 Support Active Control 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Participation in a peer support group for HIV-infected adolescents led to a significant decrease in worries about illness and a more positive perception of treatment after 2 years, compared to those who did not participate.

The percentage of adolescents with an undetectable viral load increased from 30% to 80% in the peer support group, suggesting that emotional well-being from social support may positively influence medical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a peer support group therapy for HIV-infected adolescents. Funck-Brentano, I., Dalban, C., Veber, F., et al.[2019]

Patient education through balanced videos significantly improved attitudes toward medical cannabis, as shown by a notable increase in scores on the Recreational and Medical Cannabis Attitudes Scale (RMCAS) among 111 participants.

This study highlights the effectiveness of health education in reducing stigma associated with medical cannabis, suggesting that future health policies should prioritize educational approaches to improve access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of education on attitudes toward medical cannabis. Clobes, TA., Palmier, LA., Gagnon, M., et al.[2023]

Support groups for health care professionals working with HIV/AIDS patients significantly help reduce burnout by providing emotional support and shared experiences, enhancing their effectiveness in their roles.

These groups also address feelings of isolation and difficult emotions related to their work, although challenges like group membership and dropout rates remain unresolved issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating support groups for professionals working with people with AIDS. Grossman, AH., Silverstein, C.[2007]

A systematic review of 20 studies involving 9536 participants across various low- and middle-income countries found that structural interventions, such as improving access to antiretroviral treatment and social empowerment, significantly reduced self-stigma among people living with HIV.

In contrast, studies that did not address structural risks showed mixed results, highlighting the importance of comprehensive approaches that include both individual and structural components to effectively combat self-stigma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Management of a spoiled identity': systematic review of interventions to address self-stigma among people living with and affected by HIV. Pantelic, M., Steinert, JI., Park, J., et al.[2022]

Peer support specialists often mention their own experiences with suicidal thoughts briefly, using them as a way to connect, but do not dwell on these details, which may help create a safe space for participants.

The focus of conversations tends to shift from suicide to recovery and coping strategies, suggesting that peer support can effectively guide discussions towards healing rather than solely on the challenges of suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing suicide-related self-disclosure by peer specialists: a qualitative analysis of audio-recorded sessions. Klim, C., Vitous, CA., Keller-Cohen, D., et al.[2023]

A single session of group counseling significantly reduced self-stigma and improved attitudes toward counseling among 172 college students, supporting its effectiveness as a stigma-reduction intervention.

Incorporating a self-affirmation intervention before counseling further decreased perceptions of public stigma, although it did not affect group relationships, highlighting its potential to enhance the counseling experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of group counseling and self-affirmation on stigma and group relationship development: A replication and extension. Seidman, AJ., Wade, NG., Geller, J.[2023]

A systematic review of 42 studies over the past 5 years highlights that stigma in health facilities significantly hinders diagnosis and treatment, emphasizing the need for effective interventions to improve healthcare outcomes.

While there are common approaches to reduce stigma related to HIV, mental illness, and substance abuse, there is a notable lack of interventions targeting other conditions like tuberculosis and cancer, indicating a need for broader strategies that involve both patients and healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stigma in health facilities: why it matters and how we can change it. Nyblade, L., Stockton, MA., Giger, K., et al.[2023]

A web-based education program significantly reduced depression stigma among 42 healthcare professionals and graduate students, as shown by improved scores on the Bogardus Social Distance Scale and the Depression Stigma Scale, with p-values less than 0.001.

Participants also showed a significant increase in knowledge about depression after the intervention, indicating that online education can effectively enhance understanding and reduce stigma related to mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing depression stigma using a web-based program. Finkelstein, J., Lapshin, O.[2022]

The 'Ending Self-Stigma' (ESS) intervention, consisting of 9 structured group sessions, effectively reduced internalized stigma among participants with serious mental illnesses, as evidenced by pre- and post-intervention assessments.

Participants also experienced significant increases in perceived social support and recovery orientation, highlighting the intervention's potential to enhance overall well-being and empowerment in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ending self-stigma: pilot evaluation of a new intervention to reduce internalized stigma among people with mental illnesses. Lucksted, A., Drapalski, A., Calmes, C., et al.[2022]

HIV/AIDS peer counseling by women in rural southeastern U.S. is deeply influenced by their personal identities and experiences, which helps them connect with and support other HIV-positive women.

The work of peer counselors is vital yet often unrecognized, highlighting the need for better training and support for peer-based interventions in HIV and women's health to address issues of fear, stigma, and diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embodied work: insider perspectives on the work of HIV/AIDS peer counselors. Hilfinger Messias, DK., Moneyham, L., Vyavaharkar, M., et al.[2021]

A pilot study trained six individuals living with HIV to become peer counselors using a 5-day motivational interviewing (MI) program, showing that the initiative was feasible and well-accepted by participants.

Despite enthusiasm and some skill acquisition, the peer counselors struggled with maintaining fidelity to MI techniques, particularly in avoiding direct advice, indicating a need for further training and support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SafeTalk: Training Peers to Deliver a Motivational Interviewing HIV Prevention Program. Allicock, M., Golin, CE., Kaye, L., et al.[2022]

The California Assessment of Stigma Change (CASC) effectively measures changes in stigma, attitudes, and willingness to seek mental healthcare after contact-based anti-stigma programs, showing promise in evaluating program impact.

The study demonstrated that CASC is a valid tool for monitoring changes in stigma-related attitudes among diverse groups, including high school students and college students, indicating its potential to enhance the effectiveness of anti-stigma initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The California Assessment of Stigma Change: A Short Battery to Measure Improvements in the Public Stigma of Mental Illness. Corrigan, PW., Gause, M., Michaels, PJ., et al.[2019]

A psycho-educational group therapy module called STEM, designed to help patients with schizophrenia and depression cope with stigma, was tested in a clinical trial involving 462 patients across various mental health settings.

While both the intervention and control groups showed significant improvements in quality of life and empowerment, there was no significant difference in outcomes between the two groups, indicating that the standard therapy alone was effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting stigma coping and empowerment in patients with schizophrenia and depression: results of a cluster-RCT. Gaebel, W., Zäske, H., Hesse, K., et al.[2021]

Contact interventions involving individuals who have recovered from mental illness are highly effective in reducing stigma among healthcare providers, as indicated by focus group discussions with 83 providers across five Veterans Affairs hospitals.

Providers recommended that the intervention should target all primary care and specialist providers, and they preferred face-to-face interactions for sharing lived experiences, highlighting the importance of credible contacts in stigma reduction efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider Opinions Regarding the Development of a Stigma-Reduction Intervention Tailored for Providers. Mittal, D., Corrigan, P., Drummond, KL., et al.[2022]

The Anti-Stigma Project workshop significantly improved stigma awareness and reduced prejudice among both individuals with mental illness (N = 127) and mental health providers (N = 131), indicating its effectiveness as an educational intervention.

Participants with mental illness reported increased belief in recovery, while providers showed greater support for self-determination, suggesting that enhancing stigma awareness can lead to better service delivery and empower individuals with mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing stigma through a consumer-based stigma reduction program. Michaels, PJ., Corrigan, PW., Buchholz, B., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05561595

Transdiagnostic Intervention to Reduce Internalized Health ... The Healing Health-Related Stigma (Healing HEARTS) intervention will provide group telehealth sessions adapted from prior disease-specific interventions for ...

2. trialstoday.org trialstoday.org/trial/NCT05561595

Transdiagnostic Intervention to Reduce Internalized Health ... The current project will test the effects of a novel, transdiagnostic, group counseling intervention, and peer support, to determine the optimal method for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8220835/

A systematic review and meta-analysis of group peer support ... We found evidence that group peer support may make small improvements to overall recovery but not hope or empowerment individually, or to clinical symptoms.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9294224/

Stigma and Peer-Led Interventions: A Systematic Review ... Peer-led intervention can reduce self-stigma and stigma pressure and might improve recovery and empowerment.

5. researchgate.net researchgate.net/publication/393632336_Effectiveness_of_Peer_Support_Intervention_on_Recovery_Outcomes_among_Patients_with_Schizophrenia_A_quasi-experimental_Study

Effectiveness of Peer Support Intervention on Recovery ... PDF | On Jul 1, 2025, Ayat Saif Elyazal Abdelraof and others published Effectiveness of Peer Support Intervention on Recovery Outcomes among ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7312261/

Peer Support in Mental Health: Literature Review - PMC Peer support in mental health has been variously defined in the literature and is simply known as the help and support that people with lived experience of ...

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-021-03321-z

A systematic review and meta-analysis of group peer support ... We found evidence that group peer support may make small improvements to overall recovery but not hope or empowerment individually, or to clinical symptoms.

8. ahajournals.org ahajournals.org/doi/10.1161/HCQ.0000000000000110

Psychological Outcomes and Interventions for Individuals ... This American Heart Association scientific statement summarizes the psychological outcomes of patients with congenital heart disease across the life span

9. researchgate.net researchgate.net/publication/352692923_A_systematic_review_and_meta-analysis_of_group_peer_support_interventions_for_people_experiencing_mental_health_conditions

(PDF) A systematic review and meta-analysis of group peer ... We found evidence that group peer support may make small improvements to overall recovery but not hope or empowerment individually, or to clinical symptoms.