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.
Brief Title
Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
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).
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cognitive Impairment
Depression
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
60 Years
NCT Id
NCT03043573
Org Class
Other
Org Full Name
Weill Medical College of Cornell University
Org Study Id
1603017114
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
Primary Outcomes
Outcome Description
Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS)
Outcome Measure
Change in Global Cognition assessed by RBANS
Outcome Time Frame
Baseline, 12, 24, and 52 Weeks
Secondary Ids
Secondary Id
1R01AG050514
Secondary Outcomes
Outcome Description
Disability function, as measured by the World Health Organization Disability Assessment Schedule-II (WHODAS-II) Total score
Outcome Time Frame
Baseline, 6, 12, 24, 36, and 52 Weeks
Outcome Measure
Change in disability function assessed with WHODAS-II
Outcome Description
Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Outcome Time Frame
Baseline, 6, 12, 24, 36, and 52 Weeks
Outcome Measure
Change in Depression assessed by MADRS
Outcome Description
Delayed Recall subscale of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Outcome Time Frame
Baseline, 12, 24, and 52 Weeks
Outcome Measure
Change in Episodic Memory assessed by subscale of RBANS
Outcome Description
Trail Making Test
Outcome Time Frame
Baseline, 12, 24, and 52 Weeks
Outcome Measure
Change in Executive Function assessed by Trail Making Test
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
60
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mirnova Ceide
Investigator Email
mceide@montefiore.org
Investigator Phone