- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319094
PEERS Using Peer Mentors to Deliver Depression Care
October 15, 2023 updated by: Jin hui Joo, MD, MA, Massachusetts General Hospital
Peer Enhanced Depression Care: Using Peer Mentors to Provide Self Care Support to Low Income and Minority Older Adults
Fifteen to twenty percent of older Americans (6 to 8 million people) suffer from depression but more than one-half do not receive any services, a burden disproportionately shared by low-income and minority older adults who receive few or no services.
The investigators propose to test a community-based peer model of depression care called PEERS (a peer support program) that provides self-care support for minority and low-income older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Depression is a major burden for minority and low-income older adults who are less likely to use mental health services, and development of new service delivery models is needed to improve the quality of life and address disparities to access for this group.
The investigators propose to test the effectiveness of a peer-delivered depression care program that is embedded in the community and linked to the patient's primary care clinic.
The investigators will carry out a randomized controlled trial of the PEERS program in which peer mentors who have personal experience of depression meet individually with older adults recruited in the community for 8 weekly meetings focused on relief of depressive symptoms through self-care support and linkages to community resources.
This group of low-income and minority older adults in the intervention will be compared to a group that receives non-peer visits that provide social interaction.
The PEERS program takes a chronic disease self-management approach and is guided by the conceptual frameworks of social support, peer support, and social learning.
The investigators will conduct an analysis of mediation to understand the mechanism of peer support, by measuring factors such as self-efficacy and loneliness that may be responsible for the intervention effect.
The investigators' goal is to use peer-delivered depression care to decrease the mental health morbidity of at-risk low-income and minority adults.
The potential public health impact is high because the investigators' project seeks to increase access to depression for a vulnerable group of older adults who often do not get care and leverages an existing workforce of peer workers whose services are reimbursed in many states.
Study Type
Interventional
Enrollment (Actual)
149
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 50 years and older
- depressive symptoms with Patient Health Questionnaire-9 scores > 5
- belong to an underserved population, defined as annual income less than 200% of the federal poverty level ($24,120) and/or self-identified ethnic minority
- able to communicate in English
- willing to give informed consent.
Exclusion Criteria:
- meet diagnostic criteria for mania or hypomania
- meet diagnostic criteria for psychotic syndrome
- meet diagnostic criteria for substance abuse or dependence
- acutely suicidal
- a score on the Mini-Mental State Examination (MMSE) <24
- currently taking an antidepressant medication with dosage change in the past 3 months
- receiving active psychotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEERS
Peer mentors who have experience of depression are trained and supervised to deliver depression care.
Peers will meet with depressed older adults for 8 weekly meeting lasting approximately 45 minutes.
Peer mentors will provide social support defined as emotional, informational and appraisal support that includes coping strategies.
Peers will be supervised by a mental health professional.
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Peer mentors deliver depression care that include social support and coping skills, focused on goal setting and small behavioral changes.
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Active Comparator: Social interaction
A study staff member will provide eight weekly social interaction visits and phone calls to the depressed older adult.
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Study staff will provide a combination of 8 social interaction visits and phone calls to the participants randomized to this condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression as assessed by the Patient Health Questionnaire-9
Time Frame: 12 months
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Depression will be assessed with the Patient Health Questionnaire (PHQ)-9.
There are 9 items in the questionnaire and scores range from 0 to 27.
A score of 5 indicates mild depressive symptoms, 10 - 14 indicates moderate depression, 15-19 indicates moderately severe depression, 20-27 indicates severe depression.
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2020
Primary Completion (Actual)
May 30, 2023
Study Completion (Actual)
May 30, 2023
Study Registration Dates
First Submitted
March 20, 2020
First Submitted That Met QC Criteria
March 20, 2020
First Posted (Actual)
March 24, 2020
Study Record Updates
Last Update Posted (Actual)
October 17, 2023
Last Update Submitted That Met QC Criteria
October 15, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022P001675
- R01MH123165 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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