Actively Recruiting
PATH-Pain: A Primary Care-Based Psychosocial Intervention to Improve Cognitive and Depression Outcomes in Older Adults With Mild Cognitive Impairment and Early Stage Alzheimer's Disease
Led by Weill Medical College of Cornell University · Updated on 2026-04-20
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive function, depression, and pain-related disability in older adults who have mild cognitive impairment or early stage Alzheimer's disease, along with chronic pain and depression. The study compares PATH-Pain to Attention Control Usual Care to see which approach leads to better cognitive, emotional, and functional outcomes in this population. This is a randomized control trial with a focus on real-world application in primary care settings. Participants in the PATH-Pain group receive a total of 14 therapy sessions: eight weekly in-office sessions during the first eight weeks, followed by six monthly phone sessions (three individual and three group) from weeks 9 to 36. The therapy teaches emotion regulation, problem-solving skills, and uses compensatory strategies to help manage memory challenges. A tablet app called WellPATH may be used to support emotion regulation techniques. The control group receives usual medical care from their physicians and additional structured interviews and educational sessions unrelated to cognitive impairment, pain, or depression, plus an educational booklet. During the study, participants undergo assessments at the start and at weeks 5, 9, 24, 36, and 52. These include tests of cognitive function using the Repeatable Battery for the Assessment of Neuropsychological Status, evaluations of depressive symptoms, and measures of pain-related disability. Each therapy session lasts about 50 minutes. Caregiver participation is required, and the study monitors cognitive changes, mood, and pain-related functional abilities over one year. The study aims to evaluate the overall impact of PATH-Pain compared to usual care in this group of older adults.
CONDITIONS
Brief Title
A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Diagnosis of mild cognitive impairment or early stage probable or possible Alzheimer's disease with mild cognitive deficits (MoCA score between 16 and 25)
- Mild depressive symptoms with a Montgomery-Asberg Depression Rating Scale score of 5 or higher
- Stable or no use of antidepressants, cholinesterase inhibitors, or memantine for at least 12 weeks
- Chronic pain present most days for at least 3 months with an average pain intensity score of 4 or higher
- Clinical Dementia Rating between 0.5 and 1
- Ability to provide informed consent
- Participation of a study partner such as a caregiver or family member is required
You will not qualify if you...
- Significant suicide risk as assessed by the clinical team
- Medically or neurologically unstable for safe participation
- Psychiatrically unstable for safe participation in psychotherapy
- Requiring psychiatric hospitalization at the start of the study
- Lack of fluency in English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 weeks
Participants receive 8 weekly in-office psychosocial therapy sessions followed by 6 monthly telephone sessions over the next months to improve cognitive and depression outcomes.
8 weekly in-office sessions and 6 monthly phone sessions
Duration - Up to 52 weeks
Participants are assessed at multiple timepoints up to 52 weeks after randomization to evaluate changes in cognition, depression, and pain-related disability.
Visits at weeks 9, 24, 36, and 52 post-randomization
Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine
White Plains, New York, United States, 10502
Actively Recruiting
Research Team
D
Dimtiris Kiosses, PhD
L
Laurie Evans, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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