Clinical trial NCT05081596: A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD
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
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Pain
Cognitive Impairment
Keywords: Older Adults
Mild Cognitive Impairment
Early Stage Alzheimer's Disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Baseline, Weeks 9, 36, 52
Secondary outcomes:
measure: Change in cognition, as measured by the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)
timeFrame: Baseline, Weeks 9, 36, 52
measure: Change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, Weeks 5, 9, 24, 36, 52
measure: Change in pain-related disability, as measured by the Roland-Morris Scale
timeFrame: Baseline, Weeks 5, 9, 24, 36, 52
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Dimitris Kiosses, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Mannigton C Reid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Lisa Ravdin, PhD
role: PRINCIPAL_INVESTIGATOR
References: