Minds Navigating the Diagnosis of Mild Cognitive Impairment

Last updated: November 20, 2023
Sponsor: Tuscaloosa Research & Education Advancement Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Memory Problems

Memory Loss

Treatment

Group psychotherapy delivered via video telehealth

Clinical Study ID

NCT05690243
170
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, diabetesmellitus II, hyperlipidemia/hypercholesterolemia, or obesity)
  • self-reported cognitive complaint (i.e., "Do you have problems with your memory orthinking abilities?")
  • self-reported difficulty adjusting to declines in cognitive functioning (i.e., "Havethese problems with memory or thinking impacted you, your life, or others in yourlife?")
  • English speaking, and (h) ability to provide written informed consent

Exclusion

Exclusion Criteria:

  • diagnosis of dementia or a neurodegenerative disorder
  • diagnosis of serious mental illness likely to impact cognition (i.e., schizophrenia orbipolar 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, orcognitive training program, and
  • any significant changes to psychotropic medications or medications for memory andcognition in the past month. Participants prescribed psychotropic medications andmedications for memory and cognition will be asked to stay on their current dosagesfor the duration of the study.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Group psychotherapy delivered via video telehealth
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Tuscaloosa VA Medical Center

    Tuscaloosa, Alabama 35404
    United States

    Active - Recruiting

  • Salem VA Medical Center

    Salem, Virginia 24153
    United States

    Active - Recruiting

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