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

Primary Purpose

Cognitive Dysfunction, Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group psychotherapy delivered via video telehealth
Sponsored by
Tuscaloosa Research & Education Advancement Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction focused on measuring therapy, video telehealth, veteran

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Group therapy delivered via video telehealth

    Group therapy delivered via video telehealth - wait list control

    Arm Description

    Nine sessions of 60 min each group therapy delivered via telehealth

    Nine sessions of 60 min each group therapy delivered via telehealth after a waiting period.

    Outcomes

    Primary Outcome Measures

    Feasibility of a group video-telehealth intervention for veterans with MCI
    percentage of screened, eligible subjects that enroll in intervention
    Acceptability of a group video-telehealth intervention for veterans with MCI
    percentage of subjects that attend 70% or more of scheduled sessions

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    November 21, 2022
    Last Updated
    January 9, 2023
    Sponsor
    Tuscaloosa Research & Education Advancement Corporation
    Collaborators
    United States Department of Defense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05690243
    Brief Title
    Minds Navigating the Diagnosis of Mild Cognitive Impairment
    Acronym
    MIND-MCI
    Official Title
    Minds Navigating the Diagnosis of Mild Cognitive Impairment (MiND-MCI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    January 31, 2025 (Anticipated)
    Study Completion Date
    July 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tuscaloosa Research & Education Advancement Corporation
    Collaborators
    United States Department of Defense

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Dysfunction, Mild Cognitive Impairment
    Keywords
    therapy, video telehealth, veteran

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    two-arm, single-blind, pilot randomized controlled trial with 1:1 randomization. Wait List Control.
    Masking
    Outcomes Assessor
    Masking Description
    Assessor and fidelity monitor will be blinded to treatment group.
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group therapy delivered via video telehealth
    Arm Type
    Experimental
    Arm Description
    Nine sessions of 60 min each group therapy delivered via telehealth
    Arm Title
    Group therapy delivered via video telehealth - wait list control
    Arm Type
    Other
    Arm Description
    Nine sessions of 60 min each group therapy delivered via telehealth after a waiting period.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group psychotherapy delivered via video telehealth
    Intervention Description
    Small group psychotherapy using psychoeducation and skills training aimed at addressing modifiable factors in MCI.
    Primary Outcome Measure Information:
    Title
    Feasibility of a group video-telehealth intervention for veterans with MCI
    Description
    percentage of screened, eligible subjects that enroll in intervention
    Time Frame
    At Week 0 (randomization)
    Title
    Acceptability of a group video-telehealth intervention for veterans with MCI
    Description
    percentage of subjects that attend 70% or more of scheduled sessions
    Time Frame
    At Week 10 (one week after completion of the 9 video-telehealth sessions)
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    change in the Quality of Life in Alzheimers Disease (QOL-AD) Scale
    Time Frame
    baseline to 12 week post-treatment follow-up visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patricia Pilkinton, MD
    Phone
    205-554-20944
    Email
    patricia.pilkinton@va.gov
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lindsay Jacobs, PhD
    Phone
    205-554-2337
    Email
    jacob008@ua.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patricia Pilkinton, MD
    Organizational Affiliation
    Tuscaloosa Veterans Affairs Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Lindsay Jacobs, PhD
    Organizational Affiliation
    Tuscaloosa Veterans Affairs Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Minds Navigating the Diagnosis of Mild Cognitive Impairment

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