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

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Cognitive Impairment; Depression; Pain

Treatments: Behavioral: PATH-Pain

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05081596

R01AG070055 (U.S. NIH Grant/Contract)

21-01023108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Problem Adaptation Therapy for Pain (PATH-Pain)

Experimental group

Description:

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

Treatment:

Behavioral: PATH-Pain

Attention Control Usual Care

No Intervention group

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.