A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD (PATH-Pain)

PATH-Pain: A Primary Care-Based Psychosocial Intervention To Improve Cognitive and Depression Outcomes in Older Adults With MCI and Early Stage AD

The purpose of the study is to examine the effect of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive impairment, chronic pain, and depression. The study will test if PATH-Pain has better cognitive, affective, and functional outcomes than Attention Control Usual Care.

Study Overview

• Status: Recruiting
• Conditions: Depression; Pain; Cognitive Impairment
• Intervention / Treatment: Behavioral: PATH-Pain

Detailed Description

This is a Randomized Control Trial to target cognition in older adults with MCI or Early AD, depression, and chronic pain with a psychotherapeutic intervention in primary care. This project will study the efficacy of 8 in-office acute treatment sessions (first 8 weeks) and 6 telephone delivered sessions (3 individual and 3 group) in the following months (from 9-36 weeks) of PATH- Pain vs. an equal number of sessions consisting of Attention Control Usual Care in improving cognitive, affective, and functional outcomes. Each therapy session will last approximately 50 minutes. Assessments will be conducted at study entry and weeks 5, 9 (end of acute treatment; includes assessment of cognitive functioning), 24, 36 (end of follow-up treatment; includes assessment of cognitive functioning) and 52 (includes assessments of cognitive functioning) after randomization. This is an efficacy trial, but by being delivered by certified mental health clinicians, it has a strong "real-world" focus.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dimtiris Kiosses, PhD; Phone Number: 914-997-4381; Email: dkiosses@med.cornell.edu
• Study Contact Backup: Name: Laurie Evans, MS; Phone Number: 101-2570 914-682-9100; Email: lad9011@med.cornell.edu

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10502
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Joanna Pantelides; Phone Number: 914-997-5215; Email: jop2285@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 60 years old
• MCI or early stage probable or possible AD diagnosis (as defined by Albert et al or McKhann et al) al). Patients will have at least mild cognitive deficits defined by 16 ≤ MoCA ≤ 25.
• Montgomery Asberg Depression Rating Scale (MADRS)[55] total ≥ 5, which reflects at least some mild depressive symptoms.
• Participants will be off antidepressants, cholinesterase inhibitors or memantine or on a stable dosage for at least 12 weeks.
• Chronic pain (neuropathic, nociceptive or mixed disorders): presence of pain on most days for at least 3 months and average pain intensity score >=4.
• Clinical Dementia Rating 0.5 ≤ (CDR) ≤ 1.
• Participant will have capacity to consent.
• Participation of a study partner (e.g. caregiver/family member/significant other) is required.

Exclusion Criteria:

• Deemed to have a significant suicide risk as assessed by site PI and clinical team.
• Deemed too unstable medically or neurologically to safely enroll in a research trial.
• Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy.
• Requiring psychiatric hospitalization at baseline for safety.
• Lack of English fluency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Problem Adaptation Therapy for Pain (PATH-Pain); Problem Adaptation Therapy-PAIN (PATH-PAIN) is an emotion regulation intervention aimes to reduce stress and decrease depression and disability.	Behavioral: PATH-Pain; The goals of PATH-Pain are to: 1) Teach problem solving skills to reduce negative emotions, by using emotion regulation and problem- solving strategies to overcome these difficulties. 2) Use compensatory strategies and environmental adaptation tools (notes, checklists, calendars, etc.) to avoid limitations resulting from memory problems, help improve emotion regulation, and create an easier environment to live in. If found helpful and participant agrees, a tablet application called WellPATH will be used to help the subject with emotion regulation techniques. The tablet will be given at the beginning of treatment and will be returned at the end of treatment. 3) Invite caregiver participation, when appropriate. Subjects in the PATH-PAIN group will receive 8 weekly sessions (first 8 weeks) with a study therapist and 6 monthly phone sessions (3 individual and 3 group) for 9-36 weeks. Each session will last approximately 50 minutes.
No Intervention: Attention Control Usual Care; Usual Care involves the continued medical attention and treatment provided by the subject's physician and other medical professionals in primary care. This may include medical intervention or referrals to specialists to address issues of depression, pain or memory difficulties. Subjects will also be asked to meet with a study research assistant for structured interviews and educational sessions consisting of general questions regarding health habits and other non-medical topics unrelated to cognitive impairment, pain, and depression. Additionally, subjects will receive an educational booklet on pain and depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	RBANS is a widely used neuropsychological instrument which assesses cognitive functioning. The lowest score is 40 (severe cognitive impairment) and highest is 160 (less cognitive impairment).	Baseline, Weeks 9, 36, 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognition, as measured by the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)	ADAS-Cog is a widely used measure of cognition in clinical trials for antidementia therapies. The lowest score is 0 (no cognitive impairment) and highest is 70 (severe cognitive impairment).	Baseline, Weeks 9, 36, 52
Change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)	MADRS is a depression instrument that has been used in studies of older adults with and without cognitive deficits. The lowest score is 0 (no depressive symptoms) and highest score is 60 (severe depressive symptoms).	Baseline, Weeks 5, 9, 24, 36, 52
Change in pain-related disability, as measured by the Roland-Morris Scale	Roland-Morris is a widely used instrument which measures pain-related disability. The lowest score is 0 (no disability) and highest score is 24 (severe disability).	Baseline, Weeks 5, 9, 24, 36, 52

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Dimitris Kiosses, PhD, Weill Medical College of Cornell University; Principal Investigator: Mannigton C Reid, MD, Weill Medical College of Cornell University; Principal Investigator: Lisa Ravdin, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Older Adults; Early Stage Alzheimer's Disease
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Cognitive Dysfunction; Depression
• Other Study ID Numbers: 21-01023108; R01AG070055 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
• IPD Sharing Time Frame: Data will be available as per NIH's data sharing policy.
• IPD Sharing Access Criteria: Access criteria is determined by NIH and can be requested by applying online.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No