Cognitive Rehabilitation Therapy for Mild Cognitive Impairment

NCT03225482 | Completed Results

• 2 other identifiers: NURD-019-16FI01CX001592
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Cognitive rehabilitation; Cognitive training; Cognitive remediation

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (7)

• Change in Subjective Everyday Functioning Composite Score

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

• Change in Everyday Cognition Scale

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

• Change in Cognitive Activity Inventory

  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

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

• Change in Portland Cognitive Strategies Scale

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

Study Arms (2)

ME-CCT

EXPERIMENTAL

8-week Motivationally Enhanced Compensatory Cognitive Training group

Behavioral: Motivationally Enhanced Compensatory Cognitive Training

SC

ACTIVE COMPARATOR

8-week Goal-focused Supportive Contact group

Behavioral: Goal-focused Supportive Contact

Interventions

Motivationally Enhanced Compensatory Cognitive Training BEHAVIORAL

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.

Also known as: ME-CCT

ME-CCT

Goal-focused Supportive Contact BEHAVIORAL

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.

Also known as: SC

SC

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Portland VA Medical Center: collaborator

Study Sites (2)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Elizabeth Twamley, PhD
• Organization: VA San Diego Healthcare System

Elizabeth.Twamley@va.gov

858-642-3848

Study Officials

• Elizabeth W. Twamley, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blind to treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two group randomized controlled trial.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 21, 2017
• Study Start: July 11, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)