Minds Navigating the Diagnosis of Mild Cognitive Impairment (MIND-MCI)

Minds Navigating the Diagnosis of Mild Cognitive Impairment (MiND-MCI)

The goal of this clinical trial is to find out if a 9 week group therapy using video from home will help veterans with Mild Cognitive Impairment (MCI). The main questions it aims to answer are:

• is the video therapy user-friendly for veterans?
• does it improve veterans well-being and quality-of-life?

Veterans will be asked to attend nine 1 hour small group video sessions and will complete questionnaires before and after the sessions.

Researchers will compare the group of veterans that starts the video sessions right away with a group that waits before starting the video sessions.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Dysfunction; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Group psychotherapy delivered via video telehealth

Detailed Description

The study will be achieved by conducting a two-arm, single-blind, pilot randomized controlled trial at two VA medical centers. Eighty participants at each site will be randomized in a 1:1 ratio to either the MiND-MCI group or waitlist control group. Participants will be Veterans ages 60 and older with a diagnosis of MCI, at least one cardiovascular risk factor, self-reported cognitive complaint, and self-reported difficulty adjusting to MCI diagnosis or symptoms. MiND-MCI will be delivered in nine weekly 60-minute sessions via telehealth in groups of 5 to 7 Veterans. Feasibility and acceptability process data will be tracked throughout the study. Acceptability measures pertaining to participants' perceptions of MiND-MCI will be collected at post-treatment using quantitative and qualitative assessment methods. Outcome measures collected at baseline, post-treatment, and 12-week follow-up will assess global QoL, MCI-related QoL, MCI-related self-efficacy, depression, anxiety, loneliness, coping, and cognitive functioning.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Pilkinton, MD; Phone Number: 205-554-20944; Email: patricia.pilkinton@va.gov
• Study Contact Backup: Name: Lindsay Jacobs, PhD; Phone Number: 205-554-2337; Email: jacob008@ua.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Veteran
• age 60 or older
• diagnosis of MCI, diagnosed at least a month or longer prior to screening
• diagnosis of at least one cardiovascular risk factor (i.e., hypertension, diabetes mellitus II, hyperlipidemia/hypercholesterolemia, or obesity)
• self-reported cognitive complaint (i.e., "Do you have problems with your memory or thinking abilities?")
• self-reported difficulty adjusting to declines in cognitive functioning (i.e., "Have these problems with memory or thinking impacted you, your life, or others in your life?")
• English speaking, and (h) ability to provide written informed consent

Exclusion Criteria:

• diagnosis of dementia or a neurodegenerative disorder
• diagnosis of serious mental illness likely to impact cognition (i.e., schizophrenia or bipolar I disorder)
• acutely suicidal or homicidal
• actively psychotic
• active substance use disorder
• limited life expectancy due to a terminal medical condition
• receiving ongoing chemotherapy or radiation treatment at time of screening
• residing in an assisted living or residential care facility
• currently participating in another psychotherapy, health promotion intervention, or cognitive training program, and
• any significant changes to psychotropic medications or medications for memory and cognition in the past month. Participants prescribed psychotropic medications and medications for memory and cognition will be asked to stay on their current dosages for the duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group therapy delivered via video telehealth; Nine sessions of 60 min each group therapy delivered via telehealth	Behavioral: Group psychotherapy delivered via video telehealth; Small group psychotherapy using psychoeducation and skills training aimed at addressing modifiable factors in MCI.
Other: Group therapy delivered via video telehealth - wait list control; Nine sessions of 60 min each group therapy delivered via telehealth after a waiting period.	Behavioral: Group psychotherapy delivered via video telehealth; Small group psychotherapy using psychoeducation and skills training aimed at addressing modifiable factors in MCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of a group video-telehealth intervention for veterans with MCI	percentage of screened, eligible subjects that enroll in intervention	At Week 0 (randomization)
Acceptability of a group video-telehealth intervention for veterans with MCI	percentage of subjects that attend 70% or more of scheduled sessions	At Week 10 (one week after completion of the 9 video-telehealth sessions)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Quality of Life in Alzheimers Disease (QOL-AD, range of 13-52) scale in Veterans with Mild Cognitive Impairment following participation in a 9-week video-telehealth intervention.	change in the Quality of Life in Alzheimers Disease (QOL-AD) Scale	baseline to 12 week post-treatment follow-up visit

Collaborators and Investigators

• Sponsor: Tuscaloosa Research & Education Advancement Corporation
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Patricia Pilkinton, MD, Tuscaloosa Veterans Affairs Medical Center; Principal Investigator: Lindsay Jacobs, PhD, Tuscaloosa Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Estimate): January 19, 2023

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: veteran; therapy; video telehealth
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 170 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No