Improving the Mental Health of Home Health Aides
ConditionMental Health Issue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Speak a language other than English or Spanish
Less than 1 year of job experience as a home health aide
Trial design
Design model
Parallel
Treatments tested in this trial
Living Healthy educational program + peer coaching
BehavioralThe 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 program
BehavioralParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Living Healthy educational program + Peer CoachingExperimental treatment 1 intervention
Group B: Living Healthy educational programActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fidelity to study protocol (intervention arm)
Measured by the number of total meeting attendance
Time frame
at 6 months post-intervention2
Fidelity to study protocol (control arm)
Measured by the number of total meeting attendance
Time frame
at 6 months post-intervention3
Fidelity to session completion (intervention arm)
Measured by number of sessions completed (participants)
Time frame
at 6 months post-intervention4
Fidelity to session completion (control arm)
Measured by number of sessions completed (participants)
Time frame
at 6 months post-interventionSecondary outcomes
1
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.
Time frame
From baseline to 6-month post-intervention2
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.
Time frame
From baseline to 6-month post-intervention (attention control arm)Other outcomes
1
Change in stress from baseline compared to 6 months assessed with the Cohen's Perceived Stress (PSS-4) 4-item scale
The investigators will assess the change in stress using the PSS-4, a validated scale that assesses perceived stress experienced over the prior month. This scale is composed of 4 Likert-type items with a response scale ranging from 0 (Never) to 4 (Very Often). Total score ranges from 0 to 16. Scores greater than 5 represent moderate or greater stress.
Time frame
From baseline to 6-month post-intervention2
Change in loneliness from baseline compared to 6 months assessed with the UCLA Loneliness scale 3-item scale
The investigators will assess the change in loneliness using the UCLA Loneliness scale, a validated scale that assesses feelings of loneliness. This scale is composed of 3 Likert-type items with a response scale ranging from 1 (Hardly ever or never) to 3 (Often). Scores are summed and divided by 3 to provide a mean loneliness score (1-3), with higher scores indicating greater loneliness.
Time frame
From baseline to 6-month post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
Doris Duke Charitable Foundation
Collaborator
Source ClinicalTrials.gov