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| ID | Type | Description | Link |
|---|---|---|---|
| I01CX001592 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Portland VA Medical Center | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ME-CCT | Experimental | 8-week Motivationally Enhanced Compensatory Cognitive Training group |
|
| SC | Active Comparator | 8-week Goal-focused Supportive Contact group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
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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
Normal or minimal impairment in functional activities
Does not meet criteria for dementia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth W. Twamley, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | United States | ||
| VA Portland Health Care System, Portland, OR |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ME-CCT Group | 8-week Motivationally Enhanced Compensatory Cognitive Training group |
| FG001 | Supportive Contact Control Group | 8-week Goal-focused Supportive Contact group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
156 participants completed baseline assessments and will be included in the intent-to-treat analyses. This number differs from the number enrolled (193) and the number who started treatment (145).
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| ID | Title | Description |
|---|---|---|
| BG000 | ME-CCT | 8-week Motivationally Enhanced Compensatory Cognitive Training group |
| BG001 | Supportive Contact Control Group | 8-week Goal-focused Supportive Contact group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 114 participants had useable data at baseline and 21 weeks. | Posted | Mean | Standard Deviation | Z score | assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
|
21-week study
No adverse events linked to study procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ME-CCT | 8-week Motivationally Enhanced Compensatory Cognitive Training group | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary retention | Renal and urinary disorders | Systematic Assessment | Hospitalized for urinary retention unrelated to study participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Twamley, PhD | VA San Diego Healthcare System | 858-642-3848 | Elizabeth.Twamley@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 13, 2021 | Jul 18, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Two group randomized controlled trial.
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Outcomes assessors will be blind to treatment group assignment.
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| 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. |
|
|
| 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. | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
| 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. | 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 | 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. | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
| 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. | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
| 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. | assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported. |
| 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. | assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported. |
| Portland |
| Oregon |
| 97239 |
| United States |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| OG001 | Supportive Contact Control Group | 8-week Goal-focused Supportive Contact group |
|
|
| 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. | 111 participants had useable data at baseline and 21 weeks. | Posted | Mean | Standard Deviation | z-score | assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
|
|
|
| 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. | 121 participants had useable data at baseline and 21 weeks. | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
|
|
|
| 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. | 122 participants had useable data at baseline and 21 weeks. | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
|
|
|
| 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. | 120 participants had useable data at baseline and 21 weeks. | Posted | Mean | Standard Deviation | hours | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
|
|
|
| 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. | 116 participants had useable data at baseline and 21 weeks. | Posted | Mean | Standard Deviation | hours | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
|
|
|
| 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. | 119 participants had useable data at baseline and 21 weeks. | Posted | Mean | Standard Deviation | score on a scale | assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported. |
|
|
|
| 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. | 31 participants had useable data at baseline and 21 weeks. Fitbits were only added at the San Diego site. | Posted | Mean | Standard Deviation | steps | assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported. |
|
|
|
| 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. | 25 participants had useable data at baseline and 21 weeks. Fitbits were only used at the San Diego site. | Posted | Mean | Standard Deviation | minutes | assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported. |
|
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|
| 79 |
| 3 |
| 79 |
| 0 |
| 79 |
| EG001 | Supportive Contact Control Group | 8-week Goal-focused Supportive Contact group | 0 | 66 | 3 | 66 | 0 | 66 |
|
| Slow heartbeat | Cardiac disorders | Systematic Assessment | Hospitalized for slow heartbeat due to medication overuse unrelated to study participation. |
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| Suicide attempt | Psychiatric disorders | Systematic Assessment | Hospitalized for suicide attempt in the context of alcohol intoxication unrelated to study participation. |
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| Pneumonia | Infections and infestations | Systematic Assessment | Hospitalization for pneumonia unrelated to study participation. |
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| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospitalization for COPD exacerbation unrelated to study participation. |
|
| COVID | Infections and infestations | Systematic Assessment | Hospitalization due to COVID infection unrelated to study participation. |
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