RECRUITING

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

Conditions

Depression Pain Cognitive Impairment Older Adults Mild Cognitive Impairment Early Stage Alzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-03

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05081596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Dimtiris Kiosses, PhD

CONTACT

914-997-4381

dkiosses@med.cornell.edu

Laurie Evans, MS

CONTACT

914-682-9100

lad9011@med.cornell.edu

Principal Investigator

Dimitris Kiosses, PhD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Mannigton C Reid, MD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Lisa Ravdin, PhD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

White Plains, New York, 10502

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Dimitris Kiosses, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University
Mannigton C Reid, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University
Lisa Ravdin, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-03

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2022-06-03

Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

Older Adults
Mild Cognitive Impairment
Early Stage Alzheimer's Disease

Additional Relevant MeSH Terms

Depression
Pain
Cognitive Impairment