Clinical trial NCT03043573: Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
Official title: Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Montefiore Medical Center
name: National Institute on Aging (NIA)
First posted: 2017-02-06
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change in Global Cognition assessed by RBANS
timeFrame: Baseline, 12, 24, and 52 Weeks
Secondary outcomes:
measure: Change in disability function assessed with WHODAS-II
timeFrame: Baseline, 6, 12, 24, 36, and 52 Weeks
measure: Change in Depression assessed by MADRS
timeFrame: Baseline, 6, 12, 24, 36, and 52 Weeks
measure: Change in Episodic Memory assessed by subscale of RBANS
timeFrame: Baseline, 12, 24, and 52 Weeks
measure: Change in Executive Function assessed by Trail Making Test
timeFrame: Baseline, 12, 24, and 52 Weeks
Other outcomes:
measure: Change in Stress Reduction assessed by Perceived Stress Scale
timeFrame: Baseline, 6, 12, 24, 36, and 52 Weeks
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: White Plains
country: United States
facility: Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Dimitris Kiosses, PhD
role: PRINCIPAL_INVESTIGATOR
References: