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Trial record 2 of 32 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Oregon, United States ) | NIH, U.S. Fed

Cognitive Rehabilitation Therapy for Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT03225482
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Motivationally Enhanced Compensatory Cognitive Training Behavioral: Goal-focused Supportive Contact Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two group randomized controlled trial.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors will be blind to treatment group assignment.
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation for Older Veterans With Mild Cognitive Impairment
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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 Name: 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 Name: SC




Primary Outcome Measures :
  1. Change in Objective cognitive performance composite z score [ Time Frame: baseline, 8 weeks, 21 weeks ]
    Change in composite z score

  2. Change in Functional capacity performance composite z score [ Time Frame: baseline, 8 weeks, 21 weeks ]
    Change in composite z score


Secondary Outcome Measures :
  1. Change in Subjective Everyday Functioning Composite Score (Average total score across Applied Cognition Executive Function and Applied Cognition General Concerns scales) [ Time Frame: baseline, 4, 8, 21 weeks ]
    Change in average total score

  2. Change in Everyday Cognition Scale [ Time Frame: baseline, 4, 8, 21 weeks ]
    Change in total score

  3. Change in Cognitive Activity Inventory [ Time Frame: baseline, 4, 8, 21 weeks ]
    Change in total score

  4. Change in CHAMPS Physical Activity Questionnaire for Older Adults [ Time Frame: baseline, 4, 8, 21 weeks ]
    Change in total score

  5. Change in Portland Cognitive Strategies Scale [ Time Frame: baseline, 4, 8, 21 weeks ]
    Change in total score

  6. Change in Fitbit-measured physical activity level [ Time Frame: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks ]
    Change in total step count

  7. Change in Fitbit-measured sleep efficiency [ Time Frame: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks ]
    Change in sleep efficiency



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225482


Contacts
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Contact: Amber V Keller, BA (858) 642-3878 amber.keller@va.gov
Contact: Elizabeth W Twamley, PhD (858) 552-8585 ext 3848 Elizabeth.Twamley@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Amber V Keller, BA    858-642-3878    amber.keller@va.gov   
Contact: Elizabeth W Twamley, PhD    (858) 552-8585 ext 3848    Elizabeth.Twamley@va.gov   
Principal Investigator: Elizabeth W. Twamley, PhD         
United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Marilyn Huckans, PhD    503-220-8262 ext 54689    marilyn.huckans@va.gov   
Contact: Bethany Winters       bethany.winters@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Portland VA Medical Center
Investigators
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Principal Investigator: Elizabeth W. Twamley, PhD VA San Diego Healthcare System, San Diego, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03225482     History of Changes
Other Study ID Numbers: NURD-019-16F
I01CX001592 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
Mild Cognitive Impairment
Cognitive rehabilitation
Cognitive training
Cognitive remediation

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders