Clinical trial NCT03225482: Cognitive Rehabilitation Therapy for Mild Cognitive Impairment
Official title: Cognitive Rehabilitation for Older Veterans With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Cognitive rehabilitation
Cognitive training
Cognitive remediation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Portland VA Medical Center
First posted: 2017-07-21
Enrollment: 193
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized controlled trial.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Objective cognitive performance composite z score
timeFrame: baseline, 8 weeks, 21 weeks
measure: Change in Functional capacity performance composite z score
timeFrame: baseline, 8 weeks, 21 weeks
Secondary outcomes:
measure: Change in Subjective Everyday Functioning Composite Score (Average total score across Applied Cognition Executive Function and Applied Cognition General Concerns scales)
timeFrame: baseline, 4, 8, 21 weeks
measure: Change in Everyday Cognition Scale
timeFrame: baseline, 4, 8, 21 weeks
measure: Change in Cognitive Activity Inventory
timeFrame: baseline, 4, 8, 21 weeks
measure: Change in CHAMPS Physical Activity Questionnaire for Older Adults
timeFrame: baseline, 4, 8, 21 weeks
measure: Change in Portland Cognitive Strategies Scale
timeFrame: baseline, 4, 8, 21 weeks
measure: Change in Fitbit-measured physical activity level
timeFrame: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks
measure: Change in Fitbit-measured sleep efficiency
timeFrame: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Elizabeth W. Twamley, PhD
role: PRINCIPAL_INVESTIGATOR
References: