Living Healthy Program + Peer Coaching for Mental Health Issues

(MINDSET Trial)

Recruiting at 1 trial location

Overseen By Madeline R Sterling, MD, MPH, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Non-English/Spanish, <1 year experience

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to improve the mental health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. The main questions the study aims to answer are: * Will a health program called Living Healthy, which provides health education and support with positive thinking, be used by home health aides and do they like it? * Does Living Healthy actually improve home health aides' mood compared to what they usually do to take care of themselves? Participants in the study will get an 8-week health program called Living Healthy over 3 months. Some of the participants will also have a 'peer coach' who is another home health aide who's been trained to help them with the program and learn some ways to feel better. The study will compare the experiences of home health aides who get Living Healthy plus a peer coach with those who only get the Living Healthy program.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Living Healthy Program + Peer Coaching treatment for mental health issues?

Research shows that health coaching, which is part of the Living Healthy Program, helps patients make positive lifestyle changes and improve their health. Additionally, peer support programs can empower patients by increasing their understanding of health issues and improving their overall outcomes. ^{1 2 3 4 5}

Is the Living Healthy Program + Peer Coaching safe for humans?

The available research does not provide specific safety data for the Living Healthy Program + Peer Coaching, but similar health education and coaching programs generally focus on promoting well-being and have not been associated with safety concerns. ^{6 7 8 9 10}

How is the Living Healthy Program + Peer Coaching treatment different from other treatments for mental health issues?

The Living Healthy Program + Peer Coaching is unique because it combines health education with peer support, where trained peers help guide participants through lifestyle changes, making it more personalized and supportive compared to traditional treatments that may not include peer involvement. ^{11 12 13 14 15}

Research Team

Madeline R Sterling, MD, MPH, MS

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for English-speaking home health aides over 18 years old, currently working and experiencing mental health challenges like depression, stress, or loneliness. They must have been in the job for at least a year and show signs of poor mental health through specific questionnaires.

Inclusion Criteria

You have at least one risk factor for poor mental health, as determined by PHQ8 scores of 5 or higher, PSS4 scores of 5 or higher, a score of 6 or more on the UCLA Loneliness scale and an MCS below 50 from the Short Form-12 item scale.

I am currently employed as a home health aide.

Exclusion Criteria

Less than 1 year of job experience as a home health aide

Speak a language other than English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the 8-week Living Healthy program, with some receiving additional peer coaching

8 weeks

Mostly virtual, initial onboarding may be in-person

Follow-up

Participants are monitored for retention, adherence, and changes in depressive symptoms

6 months

Treatment Details

Interventions

• Living Healthy educational program
• Living Healthy educational program + peer coaching

Trial Overview The study tests an 8-week 'Living Healthy' program aimed at improving mental well-being with educational content and support. It compares the outcomes of those who receive this program alone to those who also get help from a trained peer coach.

Participant Groups

Group I: Living Healthy educational program + Peer Coaching Experimental Treatment 1 Intervention

Home Health Aides (HHAs) will receive educational content via the CareConnect application, an eLearning mobile platform that provides educational courses for HHA certification and keeps track of their service hours to maintain NYS compliance. HHAs in this intervention arm will receive the 8-session adapted Living Healthy program via CareConnect over 3 months. Each HHA will be paired with a trained Peer Coach participant who will work through the structured program with the HHA.

Group II: Living Healthy educational program Active Control 1 Intervention

Home Health Aides (HHAs) in the attention control arm will receive an 8-session CareConnect delivered general health program (covering topics distinct from the Living Healthy intervention) that is strictly informational without any elements of CBT.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Doris Duke Charitable Foundation

Collaborator

Trials

65

Recruited

264,000+

Findings from Research

Patient education programs can significantly enhance self-management of chronic illnesses like diabetes, which is crucial for prevention and lifestyle modification.

Evaluating the effectiveness of these programs is complex due to various influencing factors, including patient demographics, disease characteristics, and healthcare system dynamics, all of which must be considered in research design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures and methods in evaluating patient education programs for chronic illness. Lane, DS., Evans, D.[2019]

The Health Coaching Program, tested by 20 family doctors over 12 months, successfully engaged 91% of invited patients, demonstrating high acceptance and feasibility among both patients and physicians.

Of the patients who participated, 37% completed all four steps of the program, and about 50% achieved a positive behavior change, indicating the program's effectiveness in promoting health behavior improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Health counseling in primary care doctors' offices: a new wind! The Health Coaching Program of the Swiss College of Primary Care Medicine]. Neuner-Jehle, S., Grüninger, U., Schmid, M.[2015]

A 12-week health coaching program involving 82 participants led to significant weight loss and improvements in diet and physical activity, even though weight loss was not the primary goal of the study.

Medical assistants can effectively be trained to provide health coaching, and both patients and providers reported high satisfaction with the program, suggesting it could be beneficial in family medicine clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of Health Coaching by Medical Assistants in Primary Care. Djuric, Z., Segar, M., Orizondo, C., et al.[2022]

This systematic review aims to evaluate the effectiveness of health coaching (HC) interventions for adults with chronic conditions, synthesizing studies published in the last four years to assess patient improvement and coaching characteristics.

If health coaching is found to be effective, it could lead to broader public health applications and integration into current management strategies for chronic diseases, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. Yang, J., Bauer, BA., Lindeen, SA., et al.[2023]

Peer-to-peer support programs significantly empower patients by enhancing their health literacy and education, leading to better healthcare choices and improved access to life-saving medications.

These programs, such as Mended Hearts, effectively reduce barriers to medication access and improve adherence, ultimately resulting in better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing barriers to medication access and adherence for ACA and Medicaid participants: a peer-to-peer, community-based approach. Baer, A., Baker, M.[2019]

The UCAN program is a weight-inclusive health and wellness coaching initiative aimed at promoting self-care behaviors among university students and staff, focusing on physical activity, nutrition, sleep, and stress management.

This program provides a model for other universities to implement similar initiatives, emphasizing the importance of mental and physical well-being over weight loss, which can help combat body image issues and disordered eating among young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

University Coaching for Activity and Nutrition (UCAN): A weight-inclusive health coaching program. Papini, NM., Lee, S., Lee, J., et al.[2023]

The 'Circle of Wellness' is a practical visual evaluation tool developed by a team in an HMO eating disorders program to assess treatment effectiveness by tracking reductions in eating disorder symptoms and improvements in quality of life.

This tool facilitates discussions between clients and clinicians about progress and future treatment planning, emphasizing a holistic view of wellness that includes both physical and mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of wellness in an eating disorders program. Sampson, J., Canterbury, M., Reinhardt, L.[2019]

A collaborative health education program between a community teaching hospital and an Intermediate School successfully educated a diverse urban student population on various health topics, including mental health, nutrition, and substance abuse.

The program's effectiveness was evaluated through student questionnaires, which not only measured impact but also allowed for student feedback to improve future events, highlighting the program's adaptability and community involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A partnership in health education between a neighborhood school and a community hospital. Weiner, PD., Cantara, JD., Kuo, NH., et al.[2019]

The 'Learning to Live Healthy' project aims to enhance the health of teachers and non-teaching staff in schools, recognizing that their well-being is crucial for promoting student health.

By focusing on workplace health management and involving all stakeholders in the process, the project seeks to create a sustainable and supportive school environment that can also address health risks related to social inequalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Learning healthy living--health management in schools. Health promotion in schools with particular consideration of socially disadvantaged students]. Windel, I.[2006]

In a study involving 14,591 health plan members over 6 years, lifestyle health coaching programs led to significant improvements, with 44.2% of participants losing 5% or more of their baseline weight and 50.5% meeting physical activity guidelines after 180 days.

The programs also showed positive outcomes in stress reduction (77% reported reduced stress), nutrition improvement (65.2%), and tobacco cessation (7% quit), highlighting the effectiveness of evidence-based coaching in promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Lifestyle Health Coaching Programs Using Trained Health Coaches and Evidence-Based Curricula at 6 Months Over 6 Years. Budzowski, AR., Parkinson, MD., Silfee, VJ.[2020]

Peer wellness coaching (PWC) significantly helped 33 participants with severe mental disorders achieve their personal health goals and showed improvements in their self-reported physical and general health after 8 to 10 weeks.

The positive effects of PWC on health-related quality of life were sustained even 90 days after the coaching sessions, suggesting its potential as an effective intervention for enhancing wellness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of peer delivered wellness coaching. Swarbrick, M., Gill, KJ., Pratt, CW.[2018]

The Inner North Brisbane Mental Health Service implemented a structured Healthy Living Program with three modules focusing on Nutrition, Physical Health, and Community Activities, which received positive feedback from participants, indicating satisfaction and intention to adopt healthier lifestyle changes.

While the program has shown immediate positive responses from participants, further research is needed to assess the long-term impact of the program on health and well-being among mental health service recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the health and lifestyle issues of people with a mental illness: the Healthy Living Programme. O'Sullivan, J., Gilbert, J., Ward, W.[2017]

A program using peer support specialists (PSS) to provide oral health education and connect individuals with serious mental illness to dental care was found to be acceptable and feasible, based on feedback from 41 respondents.

The collaborative development of educational materials by a multidisciplinary team highlights the importance of tailored interventions in improving oral health outcomes for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Health Recovery: A Peer Support Specialist-Led Health Education Program for People With Serious Mental Illness. Lapidos, A., Garlick, J., Rulli, D.[2023]

A community psychoeducation program on recovery and peer support services led to significant improvements in participants' knowledge, awareness, and interest in peer services, as shown by quantitative survey results before and after the sessions.

Participants reported feeling a sense of hope, motivation, and support from the program, highlighting the importance of role modeling and shared experiences from trained mental health peers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery 101: A Community Psychoeducation Program on Mental Health Recovery and Peer Support Services Created by an Academic Psychiatrist and Delivered by Peers. Guillory, J., North, CS.[2022]

A training model designed for mental health professionals was developed to enhance physical health interventions, emphasizing the need for integration of physical and mental health services.

Successful implementation of this training requires strong organizational support and commitment from leadership, as passive methods alone are insufficient to change practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy training: A model for effective implementation and sustainability. Davis, K., Swarbrick, P., Krzos, IM., et al.[2018]

References

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

Measures and methods in evaluating patient education programs for chronic illness. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Health counseling in primary care doctors' offices: a new wind! The Health Coaching Program of the Swiss College of Primary Care Medicine]. [2015]

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

Delivery of Health Coaching by Medical Assistants in Primary Care. [2022]

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

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. [2023]

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

Reducing barriers to medication access and adherence for ACA and Medicaid participants: a peer-to-peer, community-based approach. [2019]

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

University Coaching for Activity and Nutrition (UCAN): A weight-inclusive health coaching program. [2023]

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

Evaluation of wellness in an eating disorders program. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A partnership in health education between a neighborhood school and a community hospital. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Learning healthy living--health management in schools. Health promotion in schools with particular consideration of socially disadvantaged students]. [2006]

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

An Evaluation of Lifestyle Health Coaching Programs Using Trained Health Coaches and Evidence-Based Curricula at 6 Months Over 6 Years. [2020]

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

Impact of peer delivered wellness coaching. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Addressing the health and lifestyle issues of people with a mental illness: the Healthy Living Programme. [2017]

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

Oral Health Recovery: A Peer Support Specialist-Led Health Education Program for People With Serious Mental Illness. [2023]

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

Recovery 101: A Community Psychoeducation Program on Mental Health Recovery and Peer Support Services Created by an Academic Psychiatrist and Delivered by Peers. [2022]

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

Health literacy training: A model for effective implementation and sustainability. [2018]