NCT06071221 · Weill Medical College of Cornell University
Improving the Mental Health of Home Health Aides
(MINDSET)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Living Healthy educational program + peer coaching
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.
BEHAVIORAL
Living Healthy educational program
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- Speak a language other than English or Spanish
- Less than 1 year of job experience as a home health aide
Where
- New York, New York
Collaborators
Doris Duke Charitable Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations