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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
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
October 4, 2021
Last Updated
June 28, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA)
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
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).
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
No
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
Email
dkiosses@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie Evans, MS
Phone
914-682-9100
Ext
101-2570
Email
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
Email
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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