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

Primary Purpose

Depression, Pain, Cognitive Impairment

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PATH-Pain

About this trial

This is an interventional treatment trial for Depression focused on measuring Older Adults, Mild Cognitive Impairment, Early Stage Alzheimer's Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Problem Adaptation Therapy for Pain (PATH-Pain)

Attention Control Usual Care

Arm Description

Problem Adaptation Therapy-PAIN (PATH-PAIN) is an emotion regulation intervention aimes to reduce stress and decrease depression and disability.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

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).

Full Information

NCT ID

NCT05081596

First Posted

October 4, 2021

Last Updated

June 28, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT05081596

Brief Title

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

Acronym

PATH-Pain

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 3, 2022 (Actual)

Primary Completion Date

July 2026 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Pain, Cognitive Impairment

Keywords

Older Adults, Mild Cognitive Impairment, Early Stage Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Problem Adaptation Therapy for Pain (PATH-Pain)

Arm Type

Experimental

Arm Description

Problem Adaptation Therapy-PAIN (PATH-PAIN) is an emotion regulation intervention aimes to reduce stress and decrease depression and disability.

Arm Title

Attention Control Usual Care

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PATH-Pain

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Description

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).

Time Frame

Baseline, Weeks 9, 36, 52

Secondary Outcome Measure Information:

Title

Change in cognition, as measured by the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)

Description

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).

Time Frame

Baseline, Weeks 9, 36, 52

Title

Change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)

Description

Time Frame

Baseline, Weeks 5, 9, 24, 36, 52

Title

Change in pain-related disability, as measured by the Roland-Morris Scale

Description

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).

Time Frame

Baseline, Weeks 5, 9, 24, 36, 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dimtiris Kiosses, PhD

Phone

914-997-4381

dkiosses@med.cornell.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Laurie Evans, MS

Phone

914-682-9100

Ext

101-2570

lad9011@med.cornell.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dimitris Kiosses, PhD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mannigton C Reid, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lisa Ravdin, PhD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medicine

City

White Plains

State/Province

New York

ZIP/Postal Code

10502

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joanna Pantelides

Phone

914-997-5215

jop2285@med.cornell.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

http://nda.nih.gov/

Learn more about this trial

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

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