Mental Health IssueMINDSETNCT06071221
Improving the Mental Health of Home Health Aides
A study testing Living Healthy educational program + peer coaching and Living Healthy educational program in people with Mental Health Issue, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Living Healthy educational program + peer coaching and Living Healthy educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently working as a home health aide
- Speak English or Spanish
- ≥ 18 years of age
- Have mild depressive symptoms (Personal Health Questionnaire 8-item [PHQ8] scale ≥ 5 points), or other risk factors for poor mental health as assessed by the following domains including stress (Cohen's Perceived Stress 4-item scale [PSS4] ≥5) or loneliness (≥6 on the 3-item UCLA Loneliness scale).
Who cannot join
- Speak a language other than English or Spanish
- Less than 1 year of job experience as a home health aide
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
1199 SEIU Home Care Industry Education Fund
New York, New York, 10018
Faith Wiggins, faith.wiggins@1199funds.org
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Madeline R Sterling, MD, MPH, MS, 646-962-5029, mrs9012@med.cornell.edu
Madeline R Sterling, MD, MPH, MS
About this study
Official title: Improving the Mental Health of Home Health Aides: A Pilot Randomized Controlled 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?
Read more
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.
Read the detailed description
The overall goal of the proposed project is to improve the mental health of home health aides, one of the fastest growing sectors of the healthcare industry, comprised predominantly of middle-aged women of color with high levels of stress, depressive symptoms, and emotional exhaustion. Improving home health aides' mental health and well-being is not only critical to their own longevity as a workforce, but it has the potential to improve the health of the patients for whom they care. The investigators propose adapting the Living Healthy intervention, a 8-session peer coach-delivered cognitive behavioral therapy program on healthy habits, to the home health aide workforce and pilot testing it. The specific aim of this study is to conduct a 2-arm pilot randomized control trial among 100 home health aides (intervention arm: 50; enhanced usual care arm: 50) to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention compared to enhanced usual care (education on healthy habits alone). The primary hypothesis is that the intervention will be feasible (>80% of aides will complete the program) and acceptable (>90% of aides will report high levels of satisfaction). The secondary hypothesis is that participants who receive the intervention arm will experience fewer depressive symptoms at follow-up, compared to those in the control arm. Most of the study will be conducted virtually, while initial onboarding may be in-person.
- Conditions
- Mental Health Issue
- Being tested
- Living Healthy educational program + peer coaching, Living Healthy educational program
- Keywords
- behavioral health intervention, home health aide, depressive symptoms, peer coaching, stress
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living Healthy educational program + peer coachingBehavioural
The Living Healthy intervention is an 8-session health education program with cognitive behavioral training (CBT) techniques. For those in the interventional arm, the Living Healthy intervention program will be delivered by trained peer coaches by telephone or Zoom over 3 months. In this study, trained peer coaches are trained home health aides themselves. Informed by social cognitive theory (SCT), peer coaches train participants on cognitive behavior techniques and empower participants to adopt positive health behaviors through personalized goal setting, motivational interviewing, and peer modeling. Each content-based session incorporates principles of CBT, teaching participants to recognize and modify negative thinking and modifying outcome expectations through self-monitoring, reflection, and practice.
Living Healthy educational programBehavioural
Participants assigned to receive health education alone will be asked to read health education (online; covering aspects of the Living Healthy program) which corresponds to a weekly topic about health. They will be called by a research assistant each week to prompt them to do this and answer any questions they might have about the materials.
| Study group | Role | What they receive |
|---|---|---|
| Living Healthy educational program + Peer Coaching | Experimental | 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. Receives: Behavioral: Living Healthy educational program + peer coaching |
| Living Healthy educational program | Active comparator | 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. Receives: Behavioral: Living Healthy educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity to study protocol (intervention arm)
Measured by the number of total meeting attendance
Measured: at 6 months post-intervention
Fidelity to study protocol (control arm)
Measured by the number of total meeting attendance
Measured: at 6 months post-intervention
Fidelity to session completion (intervention arm)
Measured by number of sessions completed (participants)
Measured: at 6 months post-intervention
Fidelity to session completion (control arm)
Measured by number of sessions completed (participants)
Measured: at 6 months post-intervention
Fidelity to study protocol (intervention)
Measured by number intervention components delivered (peer coaches)
Measured: at 6 months post-intervention
Accrual rate
Measured by the number of participants enrolled divided by the number of months the study is open to enrollment
Measured: at 3 months
Refusal rate
Measured by the number of participants who refuse to participate divided by the number of eligible participants
Measured: at 3 months
Retention rate as measured by the proportion of participants who provide 6 month combined data.
Participants who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.
Measured: at 6 month post-intervention
Adherence to the intervention
Measured by the proportion of participants who completed three or more sessions
Measured: at 6 months post-intervention
Acceptability
Measured by the proportion of participants responding positively to a quantitative exit survey
Measured: at 6 months post-intervention
Secondary outcomes (2)
Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8
The investigators will assess the change in depressive symptoms using the PHQ-8, a validated scale that assesses depressive symptoms. This scale is composed of 8 Likert-type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 24. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Change will be measured with repeated Anova analysis.
Measured: From baseline to 6-month post-intervention
Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8
The investigators will assess the change in depressive symptoms using the PHQ-8, a validated scale that assesses depressive symptoms. This scale is composed of 8 Likert-type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 24. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Change will be measured with repeated Anova analysis.
Measured: From baseline to 6-month post-intervention (attention control arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start27 Jan 2025
- Primary completionOct 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Madeline R Sterling, MD, MPH, MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071221
- Sponsor's protocol ID
- 22-02024420
- Acronym
- MINDSET
- Status last verified
- Aug 2026
- First submitted
- 29 Sep 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peramsetty R, Shum M, Aucapina J, Bryan Ringel J, Young SR, Landis C, Safford MM, Andreae SJ, Escamilla Y, Wiggins F, Sadler F, Solano-Kamaiko IR, Sugijanto J, Shilvock A, Navarro Millan IY, Chowdhury K, Sterling MR. Training home health aides to become peer coaches in mental health and wellness: The MINDSET Study. J Health Psychol. 2026 Sep 25:13591053261465392. doi: 10.1177/13591053261465392. Online ahead of print.
PubMed 42788354
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Mental Health of Home Health Aides: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06071221
- Acronym / sponsor ID
- MINDSET / 22-02024420
- Conditions
- Mental Health Issue
- Keywords
- behavioral health intervention, home health aide, depressive symptoms, peer coaching, stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal of the proposed project is to improve the mental health of home health aides, one of the fastest growing sectors of the healthcare industry, comprised predominantly of middle-aged women of color with high levels of stress, depressive symptoms, and emotional exhaustion. Improving home health aides' mental health and well-being is not only critical to their own longevity as a workforce, but it has the potential to improve the health of the patients for whom they care. The investigators propose adapting the Living Healthy intervention, a 8-session peer coach-delivered cognitive behavioral therapy program on healthy habits, to the home health aide workforce and pilot testing it. The specific aim of this study is to conduct a 2-arm pilot randomized control trial among 100 home health aides (intervention arm: 50; enhanced usual care arm: 50) to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention compared to enhanced usual care (education on healthy habits alone). The primary hypothesis is that the intervention will be feasible (>80% of aides will complete the program) and acceptable (>90% of aides will report high levels of satisfaction). The secondary hypothesis is that participants who receive the intervention arm will experience fewer depressive symptoms at follow-up, compared to those in the control arm. Most of the study will be conducted virtually, while initial onboarding may be in-person.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Living Healthy educational program + Peer Coaching | Experimental | Behavioral: Living Healthy educational program + peer coachingHome 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. |
| Living Healthy educational program | Active comparator | Behavioral: Living Healthy educational programHome 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently working as a home health aide
- Speak English or Spanish
- ≥ 18 years of age
- Have mild depressive symptoms (Personal Health Questionnaire 8-item [PHQ8] scale ≥ 5 points), or other risk factors for poor mental health as assessed by the following domains including stress (Cohen's Perceived Stress 4-item scale [PSS4] ≥5) or loneliness (≥6 on the 3-item UCLA Loneliness scale).
Key exclusion criteria (2 listed)
- Speak a language other than English or Spanish
- Less than 1 year of job experience as a home health aide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living Healthy educational program + peer coachingThe Living Healthy intervention is an 8-session health education program with cognitive behavioral training (CBT) techniques. For those in the interventional arm, the Living Healthy intervention program will be delivered by trained peer coaches by telephone or Zoom over 3 months. In this study, trained peer coaches are trained home health aides themselves. Informed by social cognitive theory (SCT), peer coaches train participants on cognitive behavior techniques and empower participants to adopt positive health behaviors through personalized goal setting, motivational interviewing, and peer modeling. Each content-based session incorporates principles of CBT, teaching participants to recognize and modify negative thinking and modifying outcome expectations through self-monitoring, reflection, and practice. | Behavioural | Living Healthy educational program + Peer Coaching |
| Living Healthy educational programParticipants assigned to receive health education alone will be asked to read health education (online; covering aspects of the Living Healthy program) which corresponds to a weekly topic about health. They will be called by a research assistant each week to prompt them to do this and answer any questions they might have about the materials. | Behavioural | Living Healthy educational program |
Primary outcome
Fidelity to study protocol (intervention arm)
Time frame: at 6 months post-intervention
Measured by the number of total meeting attendance
Fidelity to study protocol (control arm)
Time frame: at 6 months post-intervention
Measured by the number of total meeting attendance
Fidelity to session completion (intervention arm)
Time frame: at 6 months post-intervention
Measured by number of sessions completed (participants)
Fidelity to session completion (control arm)
Time frame: at 6 months post-intervention
Measured by number of sessions completed (participants)
Fidelity to study protocol (intervention)
Time frame: at 6 months post-intervention
Measured by number intervention components delivered (peer coaches)
Accrual rate
Time frame: at 3 months
Measured by the number of participants enrolled divided by the number of months the study is open to enrollment
Refusal rate
Time frame: at 3 months
Measured by the number of participants who refuse to participate divided by the number of eligible participants
Retention rate as measured by the proportion of participants who provide 6 month combined data.
Time frame: at 6 month post-intervention
Participants who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.
Adherence to the intervention
Time frame: at 6 months post-intervention
Measured by the proportion of participants who completed three or more sessions
Acceptability
Time frame: at 6 months post-intervention
Measured by the proportion of participants responding positively to a quantitative exit survey
2 secondary outcomes
Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8
Time frame: From baseline to 6-month post-intervention
Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8
Time frame: From baseline to 6-month post-intervention (attention control arm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 42788354Peramsetty R, Shum M, Aucapina J, Bryan Ringel J, Young SR, Landis C, Safford MM, Andreae SJ, Escamilla Y, Wiggins F, Sadler F, Solano-Kamaiko IR, Sugijanto J, Shilvock A, Navarro Millan IY, Chowdhury K, Sterling MR. Training home health aides to become peer coaches in mental health and wellness: The MINDSET Study. J Health Psychol. 2026 Sep 25:13591053261465392. doi: 10.1177/13591053261465392. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madeline R Sterling, MD, MPH, MS principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living Healthy educational program + peer coaching and Living Healthy educational program in people with Mental Health Issue, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline R Sterling, MD, MPH, MS (6469625029, mrs9012@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity to study protocol (intervention arm) (time frame: at 6 months post-intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.