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Cognitive Rehabilitation Therapy for Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivationally Enhanced Compensatory Cognitive Training
Goal-focused Supportive Contact
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Cognitive rehabilitation, Cognitive training, Cognitive remediation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CARecruiting
  • VA Portland Health Care System, Portland, ORRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ME-CCT

SC

Arm Description

8-week Motivationally Enhanced Compensatory Cognitive Training group

8-week Goal-focused Supportive Contact group

Outcomes

Primary Outcome Measures

Change in Objective cognitive performance composite z score
Change in composite z score
Change in Functional capacity performance composite z score
Change in composite z score

Secondary Outcome Measures

Change in Subjective Everyday Functioning Composite Score (Average total score across Applied Cognition Executive Function and Applied Cognition General Concerns scales)
Change in average total score
Change in Everyday Cognition Scale
Change in total score
Change in Cognitive Activity Inventory
Change in total score
Change in CHAMPS Physical Activity Questionnaire for Older Adults
Change in total score
Change in Portland Cognitive Strategies Scale
Change in total score
Change in Fitbit-measured physical activity level
Change in total step count
Change in Fitbit-measured sleep efficiency
Change in sleep efficiency

Full Information

First Posted
July 7, 2017
Last Updated
December 22, 2022
Sponsor
VA Office of Research and Development
Collaborators
Portland VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03225482
Brief Title
Cognitive Rehabilitation Therapy for Mild Cognitive Impairment
Official Title
Cognitive Rehabilitation for Older Veterans With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Portland VA Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Cognitive rehabilitation, Cognitive training, Cognitive remediation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group randomized controlled trial.
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be blind to treatment group assignment.
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ME-CCT
Arm Type
Experimental
Arm Description
8-week Motivationally Enhanced Compensatory Cognitive Training group
Arm Title
SC
Arm Type
Active Comparator
Arm Description
8-week Goal-focused Supportive Contact group
Intervention Type
Behavioral
Intervention Name(s)
Motivationally Enhanced Compensatory Cognitive Training
Other Intervention Name(s)
ME-CCT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Goal-focused Supportive Contact
Other Intervention Name(s)
SC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Objective cognitive performance composite z score
Description
Change in composite z score
Time Frame
baseline, 8 weeks, 21 weeks
Title
Change in Functional capacity performance composite z score
Description
Change in composite z score
Time Frame
baseline, 8 weeks, 21 weeks
Secondary Outcome Measure Information:
Title
Change in Subjective Everyday Functioning Composite Score (Average total score across Applied Cognition Executive Function and Applied Cognition General Concerns scales)
Description
Change in average total score
Time Frame
baseline, 4, 8, 21 weeks
Title
Change in Everyday Cognition Scale
Description
Change in total score
Time Frame
baseline, 4, 8, 21 weeks
Title
Change in Cognitive Activity Inventory
Description
Change in total score
Time Frame
baseline, 4, 8, 21 weeks
Title
Change in CHAMPS Physical Activity Questionnaire for Older Adults
Description
Change in total score
Time Frame
baseline, 4, 8, 21 weeks
Title
Change in Portland Cognitive Strategies Scale
Description
Change in total score
Time Frame
baseline, 4, 8, 21 weeks
Title
Change in Fitbit-measured physical activity level
Description
Change in total step count
Time Frame
baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks
Title
Change in Fitbit-measured sleep efficiency
Description
Change in sleep efficiency
Time Frame
baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Lykins
Phone
(858) 642-3878
Email
hannah.lykins@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth W Twamley, PhD
Phone
(858) 552-8585
Ext
3848
Email
etwamley@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth W. Twamley, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Lykins
Phone
858-642-3878
Email
hannah.lykins@va.gov
First Name & Middle Initial & Last Name & Degree
Elizabeth W Twamley, PhD
Phone
(858) 552-8585
Ext
3848
Email
etwamley@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth W. Twamley, PhD
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya E O'Neil, PhD
Phone
503-220-8262
Ext
54522
Email
Maya.Oneil@va.gov
First Name & Middle Initial & Last Name & Degree
Emily R Sano, MA
Phone
5032208262
Ext
58290
Email
Emily.Sano@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Rehabilitation Therapy for Mild Cognitive Impairment

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