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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

No Placebo-Only Group

Summary

This trial compares two types of therapy for older adults with mild memory problems and depression. One therapy uses emotional support, practical tools, an app, and caregiver help. The other provides a supportive space to talk about feelings. The goal is to see which therapy better improves memory, mood, and daily life.

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

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6, 12, 24, 36, and 52 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PATH-MCI

2017

N/A

~80

0 / 3Eligibility criteria met