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Psychosocial Intervention for Cognitive Impairment and Depression (PATH-Pain Trial)

N/A
Recruiting
Led By Mannigton C Reid, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Montgomery Asberg Depression Rating Scale (MADRS) total ≥ 5, reflecting at least some mild depressive symptoms
Chronic pain (neuropathic, nociceptive or mixed disorders): presence of pain on most days for at least 3 months and average pain intensity score >=4
Must not have
Requiring psychiatric hospitalization at baseline for safety
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 5, 9, 24, 36, 52
Awards & highlights

Summary

This trial will study if a problem-focused adaptation therapy can help improve cognitive functioning, depression, and pain-related disability in 100 older adults with cognitive impairment, chronic pain, and depression.

Who is the study for?
This trial is for older adults over 60 with mild cognitive impairment (MCI) or early-stage Alzheimer's Disease (AD), experiencing chronic pain and some depression. They must have a study partner, be on stable medication if any, and able to consent. Those not fluent in English, at risk of suicide, psychiatrically unstable, or too medically/neurologically unstable are excluded.
What is being tested?
The trial tests Problem Adaptation Therapy for Pain (PATH-Pain) against usual care to see if it improves thinking abilities, mood, and how well people can handle their daily activities when they have memory problems and chronic pain.
What are the potential side effects?
Since PATH-Pain is a psychosocial intervention rather than a drug treatment, side effects may include emotional discomfort during therapy sessions but no physical side effects like those from medication are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience mild or more severe symptoms of depression.
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I have had chronic pain most days for at least 3 months with a pain level of 4 or more.
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I have been diagnosed with early Alzheimer's or mild cognitive impairment.
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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need to be in a psychiatric hospital for my safety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 5, 9, 24, 36, 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 5, 9, 24, 36, 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Secondary study objectives
Change in cognition, as measured by the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)
Change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
Change in pain-related disability, as measured by the Roland-Morris Scale

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Problem Adaptation Therapy for Pain (PATH-Pain)Experimental Treatment1 Intervention
Problem Adaptation Therapy-PAIN (PATH-PAIN) is an emotion regulation intervention aimes to reduce stress and decrease depression and disability.
Group II: Attention Control Usual CareActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,903 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,077 Previous Clinical Trials
1,320,567 Total Patients Enrolled
Mannigton C Reid, MDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

PATH-Pain Clinical Trial Eligibility Overview. Trial Name: NCT05081596 — N/A
Cognitive Impairment Research Study Groups: Problem Adaptation Therapy for Pain (PATH-Pain), Attention Control Usual Care
Cognitive Impairment Clinical Trial 2023: PATH-Pain Highlights & Side Effects. Trial Name: NCT05081596 — N/A
PATH-Pain 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081596 — N/A
~45 spots leftby Jul 2026
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