Minds Navigating the Diagnosis of Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— MIND-MCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690243
• Other study ID #: 170
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: Tuscaloosa Research & Education Advancement Corporation
• Contact: Patricia Pilkinton, MD
• Phone: 205-554-20944
• Email: patricia.pilkinton[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 30, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Group psychotherapy delivered via video telehealth
Small group psychotherapy using psychoeducation and skills training aimed at addressing modifiable factors in MCI.

Locations

Country	Name	City	State
United States	Salem VA Medical Center	Salem	Virginia
United States	Tuscaloosa VA Medical Center	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Tuscaloosa Research & Education Advancement Corporation	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a group video-telehealth intervention for veterans with MCI	percentage of screened, eligible subjects that enroll in intervention	At Week 0 (randomization)
Primary	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	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