Minds Navigating the Diagnosis of Mild Cognitive Impairment

NCT05690243 | Unknown

• 1 other identifier: 170
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Cognitive Dysfunction; Mild Cognitive Impairment

Keywords

therapy; video telehealth; veteran

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

  baseline to 12 week post-treatment follow-up visit

Study Arms (2)

Group therapy delivered via video telehealth

EXPERIMENTAL

Nine sessions of 60 min each group therapy delivered via telehealth

Behavioral: Group psychotherapy delivered via video telehealth

Group therapy delivered via video telehealth - wait list control

OTHER

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

Behavioral: Group psychotherapy delivered via video telehealth

Interventions

Group psychotherapy delivered via video telehealth BEHAVIORAL

Small group psychotherapy using psychoeducation and skills training aimed at addressing modifiable factors in MCI.

Group therapy delivered via video telehealth; Group therapy delivered via video telehealth - wait list control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tuscaloosa Research & Education Advancement Corporation: lead
• United States Department of Defense: collaborator

Study Sites (2)

Tuscaloosa VA Medical Center

Tuscaloosa, Alabama, 35404, United States

RECRUITING

Salem VA Medical Center

Salem, Virginia, 24153, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Patricia Pilkinton, MD

  Tuscaloosa Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

• Lindsay Jacobs, PhD

  Tuscaloosa Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Pilkinton, MD

CONTACT

205-554-20944; patricia.pilkinton@va.gov

Lindsay Jacobs, PhD

CONTACT

205-554-2337; jacob008@ua.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor and fidelity monitor will be blinded to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Staff, Research Service, Tuscaloosa Veterans Affairs Medical Center

Model Details: two-arm, single-blind, pilot randomized controlled trial with 1:1 randomization. Wait List Control.

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: January 19, 2023
• Study Start: October 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)