NCT06358404

Brief Summary

The purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

April 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

May 12, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

April 5, 2024

Last Update Submit

May 9, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Feasibility of Intervention

    Level of participant engagement: how many screened older adults agree to participate in the intervention and complete baseline assessments

    Measured at baseline enrollment

  • Acceptability of Intervention

    Number of meetings older adults complete with peer coach

    Measured during intervention (8 weeks)

  • Fidelity of Intervention

    Degree of adherence to intervention

    Measured during intervention (8 weeks)

Study Arms (1)

Intervention

OTHER

Peer coaches will deliver the PeersCOG intervention to participants.

Behavioral: PeersCOG

Interventions

PeersCOGBEHAVIORAL

. The intervention will consist of 8 weekly video chats focused on emotional, appraisal, and informational support delivered by community-based older adult peer coaches to adults 60 years of age and older with subthreshold depression and SCD.

Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults aged 60+
  • Endorse subjective cognitive decline
  • Endorse depressive symptoms
  • not currently experiencing suicidal ideation nor active, untreated manic, psychotic, or substance use disorder
  • fluent in English and able to give informed consent

You may not qualify if:

  • Meets diagnostic criteria for mild cognitive impairment or Alzheimer's dementia
  • Meets diagnostic criteria for a current major depressive disorder
  • have a history of neurological and psychiatric comorbidities such as major depressive disorder in the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Central Study Contacts

Jin Hui Joo, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 10, 2024

Study Start

May 1, 2024

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

May 12, 2025

Record last verified: 2025-05

Locations