Minds Navigating the Diagnosis of Mild Cognitive Impairment

NCT ID: NCT05690243

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Cognitive Dysfunction Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two-arm, single-blind, pilot randomized controlled trial with 1:1 randomization. Wait List Control.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessor and fidelity monitor will be blinded to treatment group.

Study Groups

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Group therapy delivered via video telehealth

Nine sessions of 60 min each group therapy delivered via telehealth

Group Type EXPERIMENTAL

Group psychotherapy delivered via video telehealth

Intervention Type BEHAVIORAL

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

Group therapy delivered via video telehealth - wait list control

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

Group Type OTHER

Group psychotherapy delivered via video telehealth

Intervention Type BEHAVIORAL

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

Interventions

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Group psychotherapy delivered via video telehealth

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Tuscaloosa Research & Education Advancement Corporation

OTHER

Sponsor Role lead

Responsible Party

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Lori Davis, MD

Associate Chief of Staff, Research Service, Tuscaloosa Veterans Affairs Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Pilkinton, MD

Role: PRINCIPAL_INVESTIGATOR

Tuscaloosa Veterans Affairs Medical Center

Lindsay Jacobs, PhD

Role: PRINCIPAL_INVESTIGATOR

Tuscaloosa Veterans Affairs Medical Center

Locations

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Tuscaloosa VA Medical Center

Tuscaloosa, Alabama, United States

Site Status RECRUITING

Salem VA Medical Center

Salem, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia Pilkinton, MD

Role: CONTACT

205-554-20944

Lindsay Jacobs, PhD

Role: CONTACT

205-554-2337

Facility Contacts

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Patricia Pilkinton, MD

Role: primary

205-554-2944

Katherine Luci, PsyD

Role: primary

540-982-2463

Other Identifiers

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170

Identifier Type: -

Identifier Source: org_study_id