NCT04319094

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 20, 2024

Completed
Last Updated

November 20, 2024

Status Verified

October 1, 2024

Enrollment Period

3.3 years

First QC Date

March 20, 2020

Results QC Date

May 21, 2024

Last Update Submit

October 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire-9

    Depression will be assessed with the Patient Health Questionnaire (PHQ)-9. The PHQ-9 score is summed. 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.

    Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention

Secondary Outcomes (11)

  • Rand Health Survey Short Form 36 - Physical Functioning

    Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention

  • Rand Health Survey Short Form 36 Item - Social Functioning

    Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention

  • Rand Health Survey Short Form 36 Item - Emotional Functioning

    Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention

  • Cornell Health Service Index - ER Service Use

    Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention

  • Engagement - Adherence

    Intervention 1-8 weeks

  • +6 more secondary outcomes

Study Arms (2)

PEERS

EXPERIMENTAL

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.

Behavioral: PEERS

Social interaction

ACTIVE COMPARATOR

A study staff member will provide eight weekly social interaction visits and phone calls to the depressed older adult.

Other: Social interaction

Interventions

PEERSBEHAVIORAL

Peer mentors deliver depression care that include social support and coping skills, focused on goal setting and small behavioral changes.

PEERS

Study staff will provide a combination of 8 social interaction visits and phone calls to the participants randomized to this condition.

Social interaction

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Joo JH, Xie A, Choi N, Gallo JJ, Zhong Y, Ma M, Locascio JJ, Khemraj U, Mace RA, Solomon P. A Mixed Methods Effectiveness Study of a Peer Support Intervention for Older Adults During the COVID-19 Pandemic: Results of a Randomized Clinical Trial. Am J Geriatr Psychiatry. 2025 Apr;33(4):389-401. doi: 10.1016/j.jagp.2024.09.013. Epub 2024 Oct 10.

MeSH Terms

Conditions

Depression

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Limitations and Caveats

Drop outs leading to small number of subjects analyzed at 12 month follow up.

Results Point of Contact

Title
Dr. Jin hui Joo
Organization
Mass General Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

March 20, 2020

First Posted

March 24, 2020

Study Start

February 17, 2020

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

November 20, 2024

Results First Posted

November 20, 2024

Record last verified: 2024-10

Locations