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

NCT05081596 | Recruiting DMC

• 2 other identifiers: 21-01023108R01AG070055
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Pain; Cognitive Impairment

Keywords

Older Adults; Mild Cognitive Impairment; Early Stage Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Change in cognitive functioning, as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  RBANS is a widely used neuropsychological instrument which assesses cognitive functioning. The lowest score is 40 (severe cognitive impairment) and highest is 160 (less cognitive impairment).

  Baseline, Weeks 9, 36, 52

Secondary Outcomes (3)

• Change in cognition, as measured by the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)

  Baseline, Weeks 9, 36, 52

• Change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline, Weeks 5, 9, 24, 36, 52

• Change in pain-related disability, as measured by the Roland-Morris Scale

  Baseline, Weeks 5, 9, 24, 36, 52

Study Arms (2)

Problem Adaptation Therapy for Pain (PATH-Pain)

EXPERIMENTAL

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

Behavioral: PATH-Pain

Attention Control Usual Care

NO 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.

Interventions

PATH-Pain BEHAVIORAL

The goals of PATH-Pain are to: 1) Teach problem solving skills to reduce negative emotions, by using emotion regulation and problem- solving strategies to overcome these difficulties. 2) Use compensatory strategies and environmental adaptation tools (notes, checklists, calendars, etc.) to avoid limitations resulting from memory problems, help improve emotion regulation, and create an easier environment to live in. If found helpful and participant agrees, a tablet application called WellPATH will be used to help the subject with emotion regulation techniques. The tablet will be given at the beginning of treatment and will be returned at the end of treatment. 3) Invite caregiver participation, when appropriate. Subjects in the PATH-PAIN group will receive 8 weekly sessions (first 8 weeks) with a study therapist and 6 monthly phone sessions (3 individual and 3 group) for 9-36 weeks. Each session will last approximately 50 minutes.

Problem Adaptation Therapy for Pain (PATH-Pain)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Weill Cornell Medicine

White Plains, New York, 10502, United States

RECRUITING

MeSH Terms

Conditions

Depression; Pain; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dimitris Kiosses, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Mannigton C Reid, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Lisa Ravdin, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimtiris Kiosses, PhD

CONTACT

914-997-4381; dkiosses@med.cornell.edu

Laurie Evans, MS

CONTACT

914-682-9100; lad9011@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: June 3, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available as per NIH's data sharing policy.
• Access Criteria: Access criteria is determined by NIH and can be requested by applying online.

Locations

US (1)