Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02664038 |
| Other study ID # |
D2017-R |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 22, 2016 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Alcohol Use Disorders (AUDs) have a significant public health impact and are highly prevalent
in Veterans. Alcohol related brain effects on neurocognition (attention, memory and executive
function) reduce ability to benefit from current treatments. These cognitive impairments are
especially common in the early phase of recovery, persist over years and get worse with age.
Recent research suggests that cognitive remediation therapy (CRT) may improve attention,
memory and executive function in other disorders, and the investigators just completed pilot
study with AUD Veterans found significantly greater improvements for those receiving CRT. The
proposed study examines AUD outcomes and neurocognitive improvements when CRT is combined
with a standardized alcohol treatment. The investigators hypothesize that CRT will improve
neurocognition and AUD outcomes more than standardized alcohol treatment alone. Findings will
determine whether CRT augmentation can benefit Veterans with AUDs.
Description:
This study aims to determine whether a combined intervention of cognitive remediation therapy
(CRT) and Individual Drug Counseling (IDC) can benefit older Veterans in the initial phase of
alcohol abuse treatment by improving abstinence outcomes and neurocognition. Substantial
cognitive impairment is associated with alcohol use disorders (AUD), and becomes worse with
years of use and the aging processes. In particular, Veterans entering treatment for AUD
display cognitive deficits that may reduce their ability to benefit from treatment. While
there is considerable variety in the severity and types of cognitive impairment found in
newly recovering patients, problems with attention, learning and memory and executive
function are common. Since treatment requires that the individual be able to sustain
attention, remember what is learned, and apply it to recovery, impaired underlying cognitive
processes make successful treatment less likely. Moreover, problems with executive
functioning and other pre-frontal cognitive processes have been associated with decreased
treatment retention and poorer AUD treatment outcomes. Although cognition can improve with
sustained abstinence, it is during the early phase of recovery, when cognition is most
impaired, that patients receive the most intensive treatment. AUD is a major cause of
suffering and functional disability for older Veterans and a common co-morbidity with other
physical and mental disorders. Finding more effective treatments of AUD remains a priority
for VA healthcare.
The purpose of the proposed study is to learn whether CRT plus IDC, an evidence-based
outpatient AUD treatment is more effective than a Game-Play Placebo plus IDC. Game-Play
Placebo has been used to provide equipoise between conditions in other CRT studies and in a
current CRT study with mTBI Veterans funded by DoD being conducted by the PI. The current
study is a randomized controlled trial (RCT) with a target enrollment of 90 Veterans in the
initial phase of AUD treatment. The study is sufficiently powered to allow us to fulfill the
following aims and test their related hypotheses:
Specific Primary Aim # 1: To determine if CRT+IDC is more effective than Game-Play Placebo
+IDC in decreasing alcohol use in older Veterans during the 3 month active intervention
period.
Ho1: CRT+IDC will be more effective than Game-Play Placebo+IDC in reducing heavy drinking
days and decreasing days of use as measured by Breathalyzer and Timeline Follow-back Method
(TLFB) during the 90 days of active intervention.
Secondary Aim #1: To determine if CRT+IDC is more effective than Game-Play Placebo+ IDC in
sustaining decreased alcohol use in older Veterans at the end of 6 months (3 months after the
active intervention period).
Ho2: CRT+IDC will be more effective than Game-Play Placebo+IDC in reducing heavy drinking
days and decreasing days of use as measured by Breathalyzer and Timeline Follow-back Method
(TLFB) for the 30 days preceding 6 month follow-up.
Secondary Aim #2: To determine if the combination of CRT and IDC is more effective than game
play placebo and IDC in improving neurocognitive functioning.
Ho3: Veterans receiving CRT+IDC will show greater improvement than Veterans receiving
Game-Play Placebo+IDC at 3 month follow-up on a global index of neurocognitive function, and
on an index of working memory and an index of executive function.
Ho4: Differential improvements in neurocognitive function will be sustained at 6 month
follow-up.
