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

NCT05081596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Dimitris Kiosses, PhD · Weill Medical College of Cornell University

  • Mannigton C Reid, MD · Weill Medical College of Cornell University

  • Lisa Ravdin, PhD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-03
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081596 on ClinicalTrials.gov