R01AG070055
Project Grant
Overview
Grant Description
Path-Pain: A Primary Care-Based Psychosocial Intervention to Improve Cognitive and Depression Outcomes in Older Adults with MCI and Early Stage AD
This MPI R01 combines the expertise of the Departments of Psychiatry, Neurology, and Internal Medicine at Weill Cornell Medicine to address Mild Cognitive Impairment (MCI) and early stage Alzheimer's Disease/Alzheimer's Disease Related Dementia (AD/ADRD) in patients with comorbid chronic pain and depression. We propose to test whether Problem Adaptation Therapy for Pain (Path-Pain), a novel primary care-based psychosocial intervention designed to reduce stress in MCI and early stage AD/ADRD patients with comorbid depression and pain, has better cognitive, affective, and functional outcomes than attention control usual care.
Path-Pain is an easy-to-administer psychosocial intervention designed to improve emotion regulation and reduce stress in older adults with MCI or early stage AD/ADRD, chronic pain, and depression. To reduce stress, Path-Pain aims to:
A) Reduce negative emotions associated with pain and pain-related disability;
B) Reduce negative emotions that interfere with pain treatment (e.g., hopelessness, helplessness);
C) Increase positive emotions and increase engagement in pleasurable activities;
D) Help patients identify addressable problems in their lives and try to find the best possible solution to these problems;
E) Reduce interpersonal tension between patients and family members, caregivers, and friends;
F) Shift attention during experiences of pain to reduce pain intensity.
To achieve these aims, Path-Pain employs emotion regulation, problem-solving, and behavioral activation techniques. In our preliminary study, Path-Pain participants showed high acceptability and treatment satisfaction with the intervention.
Based on our power analysis, we will randomize 100 older adults (60 years and older) with MCI or early stage dementia (probable or possible Alzheimer's Disease), comorbid depression, and chronic pain to 8 weekly in-office sessions and 6 monthly phone (3 individual and 3 group) sessions of Path-Pain vs. attention control usual care in 4 primary care sites. The attention control usual care arm consists of usual care, a pamphlet on pain and depression, and a structured interview of the same duration as each Path-Pain session. The structured interview aims to control for attention and time and will consist of general questions regarding health habits and other non-medical topics unrelated to cognitive impairment, pain, and depression.
The investigators have shown evidence of feasibility of recruitment, retention, and assessment procedures for the proposed study. Assessments will be performed at baseline and weeks 5 (no cognitive outcomes), 9, 24 (no cognitive outcomes), 36, and 52 by research assistants unaware of the study hypotheses and the participants' randomization status.
Path-Pain will be administered by certified mental health workers, and the attention-control sessions will be administered by a non-clinician team member experienced in structured interviews.
This MPI R01 combines the expertise of the Departments of Psychiatry, Neurology, and Internal Medicine at Weill Cornell Medicine to address Mild Cognitive Impairment (MCI) and early stage Alzheimer's Disease/Alzheimer's Disease Related Dementia (AD/ADRD) in patients with comorbid chronic pain and depression. We propose to test whether Problem Adaptation Therapy for Pain (Path-Pain), a novel primary care-based psychosocial intervention designed to reduce stress in MCI and early stage AD/ADRD patients with comorbid depression and pain, has better cognitive, affective, and functional outcomes than attention control usual care.
Path-Pain is an easy-to-administer psychosocial intervention designed to improve emotion regulation and reduce stress in older adults with MCI or early stage AD/ADRD, chronic pain, and depression. To reduce stress, Path-Pain aims to:
A) Reduce negative emotions associated with pain and pain-related disability;
B) Reduce negative emotions that interfere with pain treatment (e.g., hopelessness, helplessness);
C) Increase positive emotions and increase engagement in pleasurable activities;
D) Help patients identify addressable problems in their lives and try to find the best possible solution to these problems;
E) Reduce interpersonal tension between patients and family members, caregivers, and friends;
F) Shift attention during experiences of pain to reduce pain intensity.
To achieve these aims, Path-Pain employs emotion regulation, problem-solving, and behavioral activation techniques. In our preliminary study, Path-Pain participants showed high acceptability and treatment satisfaction with the intervention.
Based on our power analysis, we will randomize 100 older adults (60 years and older) with MCI or early stage dementia (probable or possible Alzheimer's Disease), comorbid depression, and chronic pain to 8 weekly in-office sessions and 6 monthly phone (3 individual and 3 group) sessions of Path-Pain vs. attention control usual care in 4 primary care sites. The attention control usual care arm consists of usual care, a pamphlet on pain and depression, and a structured interview of the same duration as each Path-Pain session. The structured interview aims to control for attention and time and will consist of general questions regarding health habits and other non-medical topics unrelated to cognitive impairment, pain, and depression.
The investigators have shown evidence of feasibility of recruitment, retention, and assessment procedures for the proposed study. Assessments will be performed at baseline and weeks 5 (no cognitive outcomes), 9, 24 (no cognitive outcomes), 36, and 52 by research assistants unaware of the study hypotheses and the participants' randomization status.
Path-Pain will be administered by certified mental health workers, and the attention-control sessions will be administered by a non-clinician team member experienced in structured interviews.
Funding Goals
TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
New York,
New York
100654805
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 375% from $718,167 to $3,411,409.
Weill Medical College Of Cornell University was awarded
Path-Pain Intervention for MCI & Early AD/ADRD
Project Grant R01AG070055
worth $3,411,409
from National Institute on Aging in August 2021 with work to be completed primarily in New York New York United States.
The grant
has a duration of 5 years and
was awarded through assistance program 93.866 Aging Research.
The Project Grant was awarded through grant opportunity Early Stage Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional).
Status
(Ongoing)
Last Modified 8/20/25
Period of Performance
8/15/21
Start Date
7/31/26
End Date
Funding Split
$3.4M
Federal Obligation
$0.0
Non-Federal Obligation
$3.4M
Total Obligated
Activity Timeline
Transaction History
Modifications to R01AG070055
Additional Detail
Award ID FAIN
R01AG070055
SAI Number
R01AG070055-1524282271
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75NN00 NIH National Insitute on Aging
Funding Office
75NN00 NIH National Insitute on Aging
Awardee UEI
YNT8TCJH8FQ8
Awardee CAGE
1UMU6
Performance District
NY-12
Senators
Kirsten Gillibrand
Charles Schumer
Charles Schumer
Budget Funding
Federal Account | Budget Subfunction | Object Class | Total | Percentage |
---|---|---|---|---|
National Institute on Aging, National Institutes of Health, Health and Human Services (075-0843) | Health research and training | Grants, subsidies, and contributions (41.0) | $1,382,282 | 100% |
Modified: 8/20/25