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Mild Cognitive ImpairmentNCT03225482

Cognitive Rehabilitation Therapy for Mild Cognitive Impairment

A study testing Motivationally Enhanced Compensatory Cognitive Training and Goal-focused Supportive Contact in people with Mild Cognitive Impairment, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Motivationally Enhanced Compensatory Cognitive Training and Goal-focused Supportive Contact
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
2 sitesUnited States
Study dates
11 Jul 2018to 30 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97239

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161-0002

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Motivationally Enhanced Compensatory Cognitive Training, Goal-focused Supportive Contact
Keywords
Mild Cognitive Impairment, Cognitive rehabilitation, Cognitive training, Cognitive remediation
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivationally Enhanced Compensatory Cognitive TrainingBehavioural

    Also called ME-CCT

    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.

  • Goal-focused Supportive ContactBehavioural

    Also called SC

    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.

Study groups in NCT03225482
Study groupRoleWhat they receive
ME-CCTExperimental8-week Motivationally Enhanced Compensatory Cognitive Training group
Receives: Behavioral: Motivationally Enhanced Compensatory Cognitive Training
SCActive comparator8-week Goal-focused Supportive Contact group
Receives: Behavioral: Goal-focused Supportive Contact

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Objective Cognitive Performance Composite z Score

    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.

    Measured: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

  2. Change in Functional Capacity Performance Composite z Score

    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.

    Measured: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

Secondary outcomes (7)
  1. Change in Subjective Everyday Functioning Composite Score

    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.

    Measured: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

  2. Change in Everyday Cognition Scale

    Change in total score on the Everyday Cognition Scale. Total scores range from 39-195, with higher scores reflecting worse everyday cognition.

    Measured: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

  3. Change in Cognitive Activity Inventory

    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.

    Measured: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

  4. Change in CHAMPS Physical Activity Questionnaire for Older Adults

    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.

    Measured: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

  5. Change in Portland Cognitive Strategies Scale

    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.

    Measured: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

  6. Change in Fitbit-measured Physical Activity Level

    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.

    Measured: assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.

  7. Change in Fitbit-measured Sleep Time

    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.

    Measured: assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start11 Jul 2018
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two group randomized controlled trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03225482
Sponsor's protocol ID
NURD-019-16F
Other IDs
I01CX001592
Status last verified
Aug 2025
First submitted
7 Jul 2017
Last updated
11 Aug 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Motivationally Enhanced Compensatory Cognitive Training and Goal-focused Supportive Contact in people with Mild Cognitive Impairment, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Objective Cognitive Performance Composite z Score (time frame: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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