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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

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.

Research Team

Rebecca Pearl, PhD

Principal Investigator

University of Florida

Eligibility 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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of education on attitudes toward medical cannabis. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Promoting stigma coping and empowerment in patients with schizophrenia and depression: results of a cluster-RCT. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Stigma in health facilities: why it matters and how we can change it. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Reducing depression stigma using a web-based program. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ending self-stigma: pilot evaluation of a new intervention to reduce internalized stigma among people with mental illnesses. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Characterizing suicide-related self-disclosure by peer specialists: a qualitative analysis of audio-recorded sessions. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The effects of group counseling and self-affirmation on stigma and group relationship development: A replication and extension. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Provider Opinions Regarding the Development of a Stigma-Reduction Intervention Tailored for Providers. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Changing stigma through a consumer-based stigma reduction program. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The California Assessment of Stigma Change: A Short Battery to Measure Improvements in the Public Stigma of Mental Illness. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

SafeTalk: Training Peers to Deliver a Motivational Interviewing HIV Prevention Program. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Facilitating support groups for professionals working with people with AIDS. [2007]

13. England pubmed.ncbi.nlm.nih.gov

Embodied work: insider perspectives on the work of HIV/AIDS peer counselors. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Evaluation of a peer support group therapy for HIV-infected adolescents. [2019]

15. England 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. [2022]