N/A
N=80
Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
Cognitive Impairment · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03043573 ↗Enrolled (actual)
80
Serious AEs
7.5%
Results posted
Aug 2025
Primary outcome: Primary: Change in Global Cognition Assessed by RBANS — 434.66; 435.36; 438.46; 436 Score on a Scale — p=0.9644
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PATH-MCI (Behavioral); Supportive Therapy (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Cognition Assessed by RBANS |
434.66; 435.36; 438.46; 436; 448.57; 449.08 | 0.9644 |
| SECONDARY Change in Disability Function Assessed With WHODAS-II |
12.08; 10.95; 12.43; 9.47; 10.68; 9.58 | 0.5454 |
| SECONDARY Change in Depression Assessed by MADRS |
16.62; 16.59; 14.97; 15.03; 13.53; 12.47 | 0.9813 |
| SECONDARY Change in Episodic Memory Assessed by Delayed Recall Subscale of RBANS |
76.66; 79.59; 77.81; 81.78; 81.89; 87.04 | 0.5130 |
| SECONDARY Change in Executive Function Assessed by Trail Making Test |
24.94; 25; 24.19; 24.89; 25; 25 | 0.3248 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03043573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.