Problem Adaptation Therapy for Mild Cognitive Impairment and Depression

NCT03043573 | Completed Results DMC

• 2 other identifiers: 16030171141R01AG050514
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective, and functioning outcomes.

Conditions

Cognitive Impairment; Depression

Outcome Measures

Primary Outcomes (1)

• Change in Global Cognition Assessed by RBANS

  Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS). The total score represents the simple sum of the five cognitive domain index scores (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). Total raw scores are converted based on the subjects age and a RBANS scoring manual. Higher scores indicate better functionality. The total scores range from 200 to 800.

  Baseline, 12, 24, and 52 Weeks

Secondary Outcomes (4)

• Change in Disability Function Assessed With WHODAS-II

  Baseline, 6, 12, 24, 36, and 52 Weeks

• Change in Depression Assessed by MADRS

  Baseline, 6, 12, 24, 36, and 52 Weeks

• Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS

  Baseline, 12, 24, and 52 Weeks

• Change in Executive Function Assessed by Trail Making Test

  Baseline, 12, 24, and 52 Weeks

Other Outcomes (1)

• Change in Stress Reduction Assessed by Perceived Stress Scale

  Baseline, 6, 12, 24, 36, and 52 Weeks

Study Arms (2)

PATH-MCI

EXPERIMENTAL

Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.

Behavioral: PATH-MCI

Supportive Therapy

ACTIVE COMPARATOR

Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.

Behavioral: Supportive Therapy

Interventions

PATH-MCI BEHAVIORAL

Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.

PATH-MCI

Supportive Therapy BEHAVIORAL

ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.

Also known as: ST

Supportive Therapy

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Amnestic MCI as defined by Albert et al
• Montgomery Asberg Depression Rating Scale (MADRS) greater than 7 and MADRS total less than 30
• Participants will be off antidepressants, cholinesterase inhibitors or memantine, or on a stable dosage for at least 12 weeks without any medical recommendation to adjust dosage in next 3 months (during treatment)
• Clinical Dementia Rating (CDR) = 0.5 at screening
• Subjects will have capacity to consent

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.
• Current involvement in psychotherapy
• Lack of English fluency

Sponsors & Collaborators

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

Study Sites (4)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Depression

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Dimitris Kiosses
• Organization: Weill Cornell Medicine

dkiosses@med.cornell.edu

914-997-4381

Study Officials

• Dimitris Kiosses, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 6, 2017
• Study Start: July 1, 2017
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

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 (4)