Developing a Peer Support Intervention for Depression in SCD

April 5, 2024 updated by: Jin hui Joo, MD, MA, Massachusetts General Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

With support from the MADRC ORE Core, we will recruit 30 community-dwelling older adults to conduct an open pilot study of PeersCOG. Trained and supervised peer coaches will deliver depression care to adults 60 years of age and older with depression and subjective cognitive decline in an 8-week intervention using video chats and texts. We will use mixed methods to assess feasibility, acceptability, and fidelity. We will use validated instruments to assess the preliminary outcomes, including depression, SCD, functioning, and social factors at baseline, 8 weeks, and 3 months, and we will conduct post-intervention interviews with stakeholders at 8 weeks. Older adult participants will be asked to name a study partner who will support the older adult throughout the study in terms of study enrollment. They may also have additional perspectives on the impact of impaired cognition and depression on daily living and related needs. The older adult will not be excluded if the study partner is not available.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention
Peer coaches will deliver the PeersCOG intervention to participants.
Behavioral: PeersCOG
. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention
Time Frame: Measured at baseline enrollment
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
Time Frame: Measured during intervention (8 weeks)
Number of meetings older adults complete with peer coach
Measured during intervention (8 weeks)
Fidelity of Intervention
Time Frame: Measured during intervention (8 weeks)
Degree of adherence to intervention
Measured during intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH)

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 (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000615

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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