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

N/A
Waitlist Available
Led By Dimitris Kiosses, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Amnestic MCI as defined by Albert et al
Must not have
Lack of English fluency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6, 12, 24, 36, and 52 weeks
Awards & highlights

Summary

This trial will compare two therapies for people with mild cognitive impairment: Problem Adaptation Therapy (PATH) and Supportive Therapy (ST). The goal is to see which therapy improves cognitive, affective, and functional outcomes more.

Who is the study for?
This trial is for older adults with mild cognitive impairment and depression who are not at risk of suicide, medically or neurologically unstable, or currently in psychotherapy. They must have a specific level of depression severity, be off or on stable doses of certain medications, and able to consent.
What is being tested?
The study compares Problem Adaptation Therapy (PATH-MCI) with Supportive Therapy (ST-CI) to see which is better at improving thinking skills, mood, and daily functioning in people with memory issues and sadness.
What are the potential side effects?
Since the interventions involve therapy rather than medication, typical side effects associated with drugs may not apply. However, participants might experience emotional discomfort discussing personal issues during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't changed my antidepressant or memory drug doses for 12 weeks and won't need to during the trial.
Select...
I have been diagnosed with a type of memory loss called amnestic MCI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not fluent in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6, 12, 24, 36, and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12, 24, 36, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Global Cognition assessed by RBANS
Secondary study objectives
Change in Depression assessed by MADRS
Change in Episodic Memory assessed by subscale of RBANS
Change in Executive Function assessed by Trail Making Test
+1 more
Other study objectives
Change in Stress Reduction assessed by Perceived Stress Scale

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PATH-MCIExperimental Treatment1 Intervention
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.
Group II: Supportive TherapyActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,923 Total Patients Enrolled
37 Trials studying Depression
28,775 Patients Enrolled for Depression
Weill Medical College of Cornell UniversityLead Sponsor
1,077 Previous Clinical Trials
1,320,587 Total Patients Enrolled
67 Trials studying Depression
16,710 Patients Enrolled for Depression
Johns Hopkins UniversityOTHER
2,307 Previous Clinical Trials
14,861,829 Total Patients Enrolled
57 Trials studying Depression
29,475 Patients Enrolled for Depression

Media Library

PATH-MCI Clinical Trial Eligibility Overview. Trial Name: NCT03043573 — N/A
Depression Research Study Groups: Supportive Therapy, PATH-MCI
Depression Clinical Trial 2023: PATH-MCI Highlights & Side Effects. Trial Name: NCT03043573 — N/A
PATH-MCI 2023 Treatment Timeline for Medical Study. Trial Name: NCT03043573 — N/A
~7 spots leftby May 2025
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