Clinical trial NCT05690243: Minds Navigating the Diagnosis of Mild Cognitive Impairment
Official title: Minds Navigating the Diagnosis of Mild Cognitive Impairment (MiND-MCI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Dysfunction
Mild Cognitive Impairment
Keywords: therapy
video telehealth
veteran
Lead sponsor: Tuscaloosa Research & Education Advancement Corporation
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-01-19
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm, single-blind, pilot randomized controlled trial with 1:1 randomization. Wait List Control.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of a group video-telehealth intervention for veterans with MCI
timeFrame: At Week 0 (randomization)
measure: Acceptability of a group video-telehealth intervention for veterans with MCI
timeFrame: At Week 10 (one week after completion of the 9 video-telehealth sessions)
Secondary outcomes:
measure: 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.
timeFrame: baseline to 12 week post-treatment follow-up visit
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center
state: Alabama
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
Study officials:
affiliation: Tuscaloosa Veterans Affairs Medical Center
name: Patricia Pilkinton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tuscaloosa Veterans Affairs Medical Center
name: Lindsay Jacobs, PhD
role: PRINCIPAL_INVESTIGATOR
References: