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

  • STATUS
    Recruiting
  • End date
    Jul 17, 2027
  • participants needed
    100
  • sponsor
    Weill Medical College of Cornell University
Updated on 17 June 2022
chronic pain
dementia
antidepressants
depressive symptoms
depressed mood

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.

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.

Details
Condition Depression, Pain, Cognitive Impairment
Treatment PATH-Pain
Clinical Study IdentifierNCT05081596
SponsorWeill Medical College of Cornell University
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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