Cognitive Rehabilitation Therapy for Mild Cognitive Impairment

August 7, 2025 updated by: VA Office of Research and Development

Cognitive Rehabilitation for Older Veterans With Mild Cognitive Impairment

The number of older Veterans with Mild Cognitive Impairment (MCI) seeking care within the Veterans Affairs (VA) health care system is increasing and is expected to increase more rapidly as Vietnam era Veterans age. The cognitive effects of MCI and subsequent neurodegenerative disorders can adversely affect a Veteran's ability to function independently and failure to provide appropriate intervention can result in an increased need for healthcare services and VA benefits in the future. The VA currently spends over $19,000 annually per patient to care for Veterans with dementia (Zhu et al., 2009), and delaying the onset of dementia even by one to two years will result in substantial financial savings to the VA and quality of life gains for the Veteran. Since present pharmacological interventions have demonstrated limited efficacy, alternative treatments are needed. Therefore, an evidence-based cognitive training intervention that optimally addresses the needs of older Veterans with MCI is of critical importance to the VA patient care mission.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Due to the aging of the United States population, age-related cognitive problems resulting from Alzheimer's disease and other causes of dementia are increasingly prevalent. Before individuals are diagnosed with dementia, they typically exhibit a period of "mild cognitive impairment" (MCI). Mild cognitive problems associated with MCI frequently impact an individual's ability to perform everyday tasks, including working, independent living, and medication adherence. Veterans are at increased risk of cognitive decline, and the Veterans Healthcare Administration (VA) is now providing health care to surging numbers of older Veterans with MCI who report significant cognitive complaints, difficulties with everyday functioning, and concerns about impending dementia. Despite high patient demand, few cognitive rehabilitation interventions exist that specifically address the needs of older Veterans with MCI that are widely accessible, patient-centered, and evidence-based. To the investigators' knowledge, no randomized controlled trials have been conducted that evaluate the efficacy of manualized, brief and inexpensive, yet comprehensive (multi-modal) cognitive rehabilitation interventions for older Veterans with MCI. Hence, the primary objective of this study is to evaluate the efficacy of Motivationally Enhanced Compensatory Cognitive Training (ME-CCT), a manualized cognitive rehabilitation group treatment for older Veterans with MCI. The study's specific aims are to determine whether ME-CCT is effective for: 1) improving objective cognitive performance and functional capacity, 2) improving subjective cognitive complaints, subjective functioning, and collateral measures of everyday function, and 3) increasing modifiable protective factors (e.g., diet, exercise) associated with reduced risk for MCI. The investigators will also explore mediators and moderators of treatment effects. The overall goal is to evaluate a manualized group treatment for the symptoms of MCI that can be readily implemented in VA treatment settings. The study design makes use of the convergent availability of resources at the two participating VA Healthcare Systems in San Diego, California and Portland, Oregon to conduct a randomized controlled trial of ME-CCT. The study will recruit a sample of 216 Veterans (108 at each site) who meet criteria for MCI. Inclusion criteria will be: 1) Veterans 55 years old or older enrolled at one of the participating VAs who are able to provide informed consent, 2) Independently living, 3) Meet criteria for MCI based on previously published criteria (Petersen, 2004; Petersen, 2011), and 4) Willingness to participate in audio-recorded group sessions. Exclusion criteria will be: 1) Current substance use disorder with less than 30 days abstinence, 2) History of schizophrenia, schizoaffective disorder, or other primary psychotic disorder, 3) History of significant head trauma with loss of consciousness >30 minutes, and 4) Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group. Eligible participants will be randomly assigned to either the ME-CCT or an active control group, Goal-focused Supportive Contact (SC). The SC group will provide the same frequency and amount of therapist and peer contact as ME-CCT, but without specific training in cognitive strategies, lifestyle strategies, or motivational enhancement. 8 2-hour long weekly sessions will be delivered in both conditions. Both groups will undergo evaluations at baseline, 4 weeks (midway through the intervention), 8 weeks (immediately following the end of the intervention), and 21 weeks (3 months after completion of the intervention).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System, Portland, OR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Veterans >55 years old enrolled at one of the participating VA sites (VASDHS and VAPORHCS) who are able to provide informed consent
  • Independently living
  • Meet criteria for MCI based on previously published criteria (see below)
  • Willingness to participate in audio-recorded sessions.

  • MCI Criteria:

    • Concern about a decline in cognitive functioning expressed by a physician, informant, participant or nurse

    • Cognitive impairment in one or more of the following domains

      • executive function
      • memory
      • attention
      • language or visuospatial abilities
    • Normal or minimal impairment in functional activities
    • Does not meet criteria for dementia

Exclusion Criteria:

  • Current substance use disorder with < 30 days abstinence
  • History of schizophrenia, schizoaffective disorder, or other primary psychotic disorder
  • History of significant brain injury with loss of consciousness > 30 minutes
  • Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group or benefit from compensatory strategies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ME-CCT
8-week Motivationally Enhanced Compensatory Cognitive Training group
Behavioral: Motivationally Enhanced Compensatory Cognitive Training
ME-CCT is a manualized group-based behavioral intervention (8 weeks, 2 hours per week, 20 hours total) designed to improve cognitive and everyday functioning in patients with MCI.
Other Names:
  • ME-CCT
Active Comparator: SC
8-week Goal-focused Supportive Contact group
Behavioral: Goal-focused Supportive Contact
SC is a group therapy intervention that provides the same frequency and amount of therapist and other group member contact as ME-CCT, but does not provide training in cognitive strategies, lifestyle strategies, or motivational enhancement. The SC intervention focuses on setting and achieving short or long-term goals.
Other Names:
  • SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Objective Cognitive Performance Composite z Score
Time Frame: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

Change in composite z score on the following tests:

Hopkins Verbal Learning Test-Revised (HVLT-R) Brief Visuospatial Memory Test-Revised (BVMT-R) Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span WAIS-IV Coding Delis-Kaplan Executive Function System (D-KEFS) Trails, Number and Letter Sequencing D-KEFS Trails, Number-Letter Switching D-KEFS Color-Word Interference Test, Inhibition and Inhibition-Switching A Z score of 0 represents the sample mean. Higher composite Z scores reflect better performance.
assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in Functional Capacity Performance Composite z Score
Time Frame: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

Change in composite z score on the following measures:

UCSD Performance-Based Skills Assessment-Brief (UPSA-B) Medication Management Ability Assessment (MMAA) Neuropsychological Assessment Battery Daily Living Memory Neuropsychological Assessment Battery Judgment Neuropsychological Assessment Battery Driving Scenes A Z score of 0 represents the sample mean. Higher Z scores reflect better performance.
assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Subjective Everyday Functioning Composite Score
Time Frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

Change in average total score across Applied Cognition Executive Function and Applied Cognition General Concerns scales.

The average total score ranges from 8-40, with higher scores reflecting better subjective cognition.
assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in Everyday Cognition Scale
Time Frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in total score on the Everyday Cognition Scale. Total scores range from 39-195, with higher scores reflecting worse everyday cognition.
assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in Cognitive Activity Inventory
Time Frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in total score on the Cognitive Activity Inventory. Scores represent hours per month of cognitive activity and range from 0-730 (the number of hours in a month). Higher scores represent more hours of cognitive activity.
assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in CHAMPS Physical Activity Questionnaire for Older Adults
Time Frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in total score on the CHAMPS Physical Activity Questionnaire for Older Adults. The score reflects hours of exercise per week and ranges from 0-168 (the number of hours in one week). Higher scores reflect higher levels of exercise.
assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in Portland Cognitive Strategies Scale
Time Frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in total score on the Portland Cognitive Strategies Scale. Scores reflect use of cognitive strategies and range from 0-60, with higher scores reflecting greater use of cognitive strategies.
assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in Fitbit-measured Physical Activity Level
Time Frame: assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.
Change in total daily step count as measured by Fitbit. Scores could range from 0 steps per day to over 20,000 steps per day. Higher scores reflect more steps per day.
assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.
Change in Fitbit-measured Sleep Time
Time Frame: assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.
Change in total sleep time in minutes, per 24 hours, as measured by Fitbit. Possible scores range from 0-1440 (the number of minutes in 24 hours). Higher scores reflect more minutes of sleep.
assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Portland VA Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth W. Twamley, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NURD-019-16F
  • I01CX001592 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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