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Trial record 1 of 1 for:    nct03043573
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Problem Adaptation Therapy for Mild Cognitive Impairment and Depression (PATH-MCI)

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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

Tracking Information
First Submitted Date  ICMJE January 27, 2017
First Posted Date  ICMJE February 6, 2017
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • 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
  • Depression assessed by MADRS [ Time Frame: 52 Weeks ]
    Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score
  • Episodic Memory assessed by subscale of RBANS [ Time Frame: 52 Weeks ]
    Delayed Recall subscale of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
  • Executive Function assessed by Trail Making Test [ Time Frame: 52 Weeks ]
    Trail Making Test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 2, 2017)
Stress Reduction assessed by Perceived Stress Scale [ Time Frame: 52 Weeks ]
Perceived Stress Scale
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
Official Title  ICMJE Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cognitive Impairment
  • Depression
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: PATH-MCI
  • 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.
    Intervention: Behavioral: Supportive Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dimitris Kiosses, PhD 9149974381 dkiosses@med.cornell.edu
Contact: Laurie Evans, MS 9146829100 ext 2570 lad9011@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03043573
Other Study ID Numbers  ICMJE 1603017114
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data sharing plan of the NIA (National Institute on Aging).
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE
  • Johns Hopkins University
  • Montefiore Medical Center
Investigators  ICMJE
Principal Investigator: Dimitris Kiosses, PhD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP