Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, Cognitive rehabilitation, Cognitive training, Cognitive remediation
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).
Interventions
BEHAVIORALMotivationally 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.
BEHAVIORALGoal-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.
Sponsors
Portland VA Medical Center
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors will be blind to treatment group assignment.
Intervention model description
Two group randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Objective Cognitive Performance Composite z Score | assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. | 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. |
| Change in Functional Capacity Performance Composite z Score | assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Activity Inventory | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. | 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. |
| 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 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. |
| 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 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. |
| Change in Fitbit-measured Physical Activity Level | assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported. | 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. |
| Change in Fitbit-measured Sleep Time | assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported. | 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. |
| Change in Portland Cognitive Strategies Scale | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. | 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. |
| Change in Everyday Cognition Scale | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. | Change in total score on the Everyday Cognition Scale. Total scores range from 39-195, with higher scores reflecting worse everyday cognition. |
Countries
United States
Participant flow
Pre-assignment details
Participants were considered enrolled when they signed the informed consent form. Participants then underwent baseline assessment. Once six participants completed baseline assessments, they were randomized as a group to a condition, revealed to them on the first day of treatment. Some participants exited prior to baseline assessment or after baseline assessment but before randomization or the first day of treatment. Thus, the number initiating treatment differs from the number enrolled.
Participants by arm
| Arm | Count |
|---|---|
| ME-CCT 8-week Motivationally Enhanced Compensatory Cognitive Training group | 84 |
| Supportive Contact Control Group 8-week Goal-focused Supportive Contact group | 72 |
| Total | 156 |
Baseline characteristics
| Characteristic | Supportive Contact Control Group | Total | ME-CCT |
|---|---|---|---|
| Age, Continuous | 71.8 year STANDARD_DEVIATION 7 | 71.5 year STANDARD_DEVIATION 7.6 | 71.2 year STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 11 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 123 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 22 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 14 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 60 Participants | 120 Participants | 60 Participants |
| Sex: Female, Male Female | 7 Participants | 19 Participants | 12 Participants |
| Sex: Female, Male Male | 65 Participants | 137 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 66 |
| other Total, other adverse events | 0 / 79 | 0 / 66 |
| serious Total, serious adverse events | 3 / 79 | 3 / 66 |
Outcome results
Primary
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.
Time frame: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Population: 111 participants had useable data at baseline and 21 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ME-CCT | Change in Functional Capacity Performance Composite z Score | .11 z-score | Standard Deviation 0.41 |
| Supportive Contact Control Group | Change in Functional Capacity Performance Composite z Score | .17 z-score | Standard Deviation 0.61 |
Primary
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.
Time frame: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Population: 114 participants had useable data at baseline and 21 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ME-CCT | Change in Objective Cognitive Performance Composite z Score | .24 Z score | Standard Deviation 0.39 |
| Supportive Contact Control Group | Change in Objective Cognitive Performance Composite z Score | .14 Z score | Standard Deviation 0.35 |
Secondary
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.
Time frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Population: 116 participants had useable data at baseline and 21 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ME-CCT | Change in CHAMPS Physical Activity Questionnaire for Older Adults | -2.02 hours | Standard Deviation 9.15 |
| Supportive Contact Control Group | Change in CHAMPS Physical Activity Questionnaire for Older Adults | 1.76 hours | Standard Deviation 9.8 |
Secondary
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.
Time frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Population: 120 participants had useable data at baseline and 21 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ME-CCT | Change in Cognitive Activity Inventory | 24.37 hours | Standard Deviation 245.46 |
| Supportive Contact Control Group | Change in Cognitive Activity Inventory | -26.80 hours | Standard Deviation 288.83 |
Secondary
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.
Time frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Population: 122 participants had useable data at baseline and 21 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ME-CCT | Change in Everyday Cognition Scale | -.32 score on a scale | Standard Deviation 0.55 |
| Supportive Contact Control Group | Change in Everyday Cognition Scale | -.10 score on a scale | Standard Deviation 0.41 |
Secondary
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.
Time frame: assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.
Population: 31 participants had useable data at baseline and 21 weeks. Fitbits were only added at the San Diego site.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ME-CCT | Change in Fitbit-measured Physical Activity Level | 146.62 steps | Standard Deviation 1962.36 |
| Supportive Contact Control Group | Change in Fitbit-measured Physical Activity Level | -867.84 steps | Standard Deviation 1198.58 |
Secondary
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.
Time frame: assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.
Population: 25 participants had useable data at baseline and 21 weeks. Fitbits were only used at the San Diego site.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ME-CCT | Change in Fitbit-measured Sleep Time | -25.63 minutes | Standard Deviation 90.29 |
| Supportive Contact Control Group | Change in Fitbit-measured Sleep Time | 11.57 minutes | Standard Deviation 64.73 |
Secondary
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.
Time frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Population: 119 participants had useable data at baseline and 21 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ME-CCT | Change in Portland Cognitive Strategies Scale | 4.28 score on a scale | Standard Deviation 8.13 |
| Supportive Contact Control Group | Change in Portland Cognitive Strategies Scale | 1.65 score on a scale | Standard Deviation 7.03 |
Secondary
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.
Time frame: assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Population: 121 participants had useable data at baseline and 21 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ME-CCT | Change in Subjective Everyday Functioning Composite Score | 2.41 score on a scale | Standard Deviation 4.76 |
| Supportive Contact Control Group | Change in Subjective Everyday Functioning Composite Score | .64 score on a scale | Standard Deviation 4.46 |