Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03225482 |
| Other study ID # |
NURD-019-16F |
| Secondary ID |
I01CX001592 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 11, 2018 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
