- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03043573
Problem Adaptation Therapy for Mild Cognitive Impairment and Depression (PATH-MCI)
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dimitris Kiosses, PhD
- Phone Number: 9149974381
- Email: dkiosses@med.cornell.edu
Study Contact Backup
- Name: Laurie Evans, MS
- Phone Number: 1012570 9146829100
- Email: lad9011@med.cornell.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Recruiting
- Johns Hopkins University School Of Medicine
-
Contact:
- Paul B Rosenberg, MD
- Phone Number: 410-550-9883
- Email: prosenb9@jhmi.edu
-
Contact:
- Samantha Horn
- Phone Number: 410-550-9022
- Email: shorn8@jhmi.edu
-
-
New York
-
Bronx, New York, United States, 10461
- Completed
- Montefiore Medical Center
-
New York, New York, United States, 10065
- Recruiting
- Weill Cornell Medicine
-
Contact:
- Dimitris Kiosses, PhD
- Phone Number: 914-997-4381
- Email: dkiosses@med.cornell.edu
-
Contact:
- Laurie Evans, MS
- Phone Number: 1012570 914-682-9100
- Email: lad9011@med.cornell.edu
-
White Plains, New York, United States, 10605
- Recruiting
- Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
-
Contact:
- Dimitris Kiosses, PhD
- Phone Number: 914-997-4381
- Email: dkiosses@med.cornell.edu
-
Contact:
- Laurie Evans, MS
- Phone Number: 1012570 914-682-9100
- Email: lad9011@med.cornell.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Global Cognition assessed by RBANS
Time Frame: Baseline, 12, 24, and 52 Weeks
|
Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS)
|
Baseline, 12, 24, and 52 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in disability function assessed with WHODAS-II
Time Frame: Baseline, 6, 12, 24, 36, and 52 Weeks
|
Disability function, as measured by the World Health Organization Disability Assessment Schedule-II (WHODAS-II) Total score
|
Baseline, 6, 12, 24, 36, and 52 Weeks
|
Change in Depression assessed by MADRS
Time Frame: Baseline, 6, 12, 24, 36, and 52 Weeks
|
Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score
|
Baseline, 6, 12, 24, 36, and 52 Weeks
|
Change in Episodic Memory assessed by subscale of RBANS
Time Frame: Baseline, 12, 24, and 52 Weeks
|
Delayed Recall subscale of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
|
Baseline, 12, 24, and 52 Weeks
|
Change in Executive Function assessed by Trail Making Test
Time Frame: Baseline, 12, 24, and 52 Weeks
|
Trail Making Test
|
Baseline, 12, 24, and 52 Weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Stress Reduction assessed by Perceived Stress Scale
Time Frame: Baseline, 6, 12, 24, 36, and 52 Weeks
|
Perceived Stress Scale
|
Baseline, 6, 12, 24, 36, and 52 Weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dimitris Kiosses, PhD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1603017114
- 1R01AG050514 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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