Problem Adaptation Therapy for Mild Cognitive Impairment and Depression

NCT ID: NCT03043573

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2024-09-19

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.

Detailed Description

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. Psychotherapy, also known as talking therapy, is the use of psychological methods to help a person change and overcome problems in desired ways. 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. Supportive Therapy incorporates standard of care approaches by using non-specific techniques to provide a supportive environment and help patients to express their feelings & focus on their strengths and abilities.

The investigators plan to randomize 80 treatment subjects, older adults (40 at Cornell and 40 at Johns Hopkins) with MCI-depression. 80 study partners may also be potentially recruited. Both sites have shown feasibility of recruitment, randomization, retention, and assessment procedures for patients with MCI. Cornell has shown evidence of administration of PATH in this population. Certified mental health clinicians in PATH-MCI and ST-CI will administer 15 in-office sessions in six months.

The investigators propose to compare the effects of 15 sessions (12 weekly in first 12 weeks and 3 monthly booster sessions afterwards) of PATH-MCI vs. ST-CI in 80 older adults (treatment subjects) with MCI-depression. Research assistants, unaware of study hypotheses and participant randomization status, will perform research assessments at baseline and at 6 (no cognitive measures), 12, 24, 36 (no cognitive measures) and 52 weeks after randomization.

There will also be optional blood draws at study entry, 12, and 52 weeks. The purpose of the blood draws is to better understand whether response to psychotherapy treatment is affected by genes, by inflammation, or by the possible memory factor called BDNF (brain-derived neurotrophic factor). Also, all therapy sessions will be audiotaped (if the patient consents) and Dr. Shermer (a clinician outside of the Weill Cornell Institute of Geriatric Psychiatry) will evaluate randomly selected sessions and rate the therapists' adherence and competence based on the PATH-MCI and ST Adherence Scales

The study partner will provide information about the treatment subject and participate in treatment if agreed by the treatment subject. To explore the effects of PATH-MCI on the study partner, the investigators will collect the following data from the study partner: demographic, burden (Short Zarit Burden interview), and treatment satisfaction (Client Satisfaction Questionnaire).

Conditions

Cognitive Impairment; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PATH-MCI

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.

Group Type: EXPERIMENTAL

PATH-MCI

Intervention Type: 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.

Supportive Therapy

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.

Group Type: ACTIVE_COMPARATOR

Supportive Therapy

Intervention Type: 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.

Interventions

PATH-MCI

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.

Intervention Type: BEHAVIORAL

Supportive Therapy

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ST

Eligibility Criteria

Inclusion Criteria

• 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

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.
• Current involvement in psychotherapy
• Lack of English fluency

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitris Kiosses, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Weill Cornell Medicine

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

White Plains, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01AG050514

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1603017114

Identifier Type: -

Identifier Source: org_study_id