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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06358404
Other study ID # 2024P000615
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date April 30, 2026

Study information

Verified date April 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date April 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital National Institutes of Health (NIH)

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Acceptability of Intervention Number of meetings older adults complete with peer coach Measured during intervention (8 weeks)
Primary Fidelity of Intervention Degree of adherence to intervention Measured during intervention (8 weeks)
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