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Problem Adaptation Therapy for Mild Cognitive Impairment and Depression (PATH-MCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03043573
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
Johns Hopkins University
Montefiore Medical Center
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Depression Behavioral: PATH-MCI Behavioral: Supportive Therapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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.
Behavioral: 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.

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.
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.
Other Name: ST




Primary Outcome Measures :
  1. Global Cognition assessed by RBANS [ Time Frame: 52 Weeks ]
    Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS)


Secondary Outcome Measures :
  1. Disability function assessed with WHODAS-II [ Time Frame: 52 Weeks ]
    Disability function, as measured by the World Health Organization Disability Assessment Schedule-II (WHODAS-II) Total score

  2. Depression assessed by MADRS [ Time Frame: 52 Weeks ]
    Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score

  3. Episodic Memory assessed by subscale of RBANS [ Time Frame: 52 Weeks ]
    Delayed Recall subscale of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  4. Executive Function assessed by Trail Making Test [ Time Frame: 52 Weeks ]
    Trail Making Test


Other Outcome Measures:
  1. Stress Reduction assessed by Perceived Stress Scale [ Time Frame: 52 Weeks ]
    Perceived Stress Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 and MMSE (Mini Mental State Examination) greater than or equal to 24.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043573


Contacts
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Contact: Dimitris Kiosses, PhD 9149974381 dkiosses@med.cornell.edu
Contact: Laurie Evans, MS 9146829100 ext 2570 lad9011@med.cornell.edu

Locations
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United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21224
Contact: Paul B Rosenberg, MD    410-550-9883    prosenb9@jhmi.edu   
Contact: Nimra Jamil    410-550-9022    njamil2@jhmi.edu   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Mirnova Ceide, MD       mceide@montefiore.org   
Contact: Jessica Zwerling, MD       jzwerlin@montefiore.org   
Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine Recruiting
White Plains, New York, United States, 10605
Contact: Dimitris Kiosses, PhD    914-997-4381    dkiosses@med.cornell.edu   
Contact: Laurie Evans, MS    914-682-9100 ext 2570    lad9011@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Johns Hopkins University
Montefiore Medical Center
Investigators
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Principal Investigator: Dimitris Kiosses, PhD Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03043573    
Other Study ID Numbers: 1603017114
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing plan of the NIA (National Institute on Aging).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Cognitive Dysfunction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders