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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 5, 9, 24, 36, 52
Awards & highlights

PATH-Pain Trial 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.Check my eligibility
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.See study design
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.

PATH-Pain Trial 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.

PATH-Pain Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Secondary outcome measures
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

PATH-Pain 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
1,658 Previous Clinical Trials
28,004,399 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,329,772 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the recruitment of participants for this experiment progressing?

"Affirmative. According to information on clinicaltrials.gov, this medical experiment is currently enrolling patients and was first made available June 3rd 2022 with the most recent update occuring on June 8th of the same year. 100 subjects are sought after from one site in particular."

Answered by AI

Are there any opportunities for participants to join this research endeavor?

"Affirmative. Clinicaltrials.gov's records suggest that this clinical trial, which was opened on June 3rd 2022, is currently recruiting prospective patients. The medical experiment needs 100 individuals to be recruited from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~56 spots leftby Jul 2026