Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06134128 |
| Other study ID # |
6208 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2, 2023 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Portland VA Medical Center |
| Contact |
Kate Shirley |
| Phone |
503-220-8262 |
| Email |
kate.shirley[@]va.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Most individuals entering treatment for alcohol use disorders (AUDs) present with cognitive
deficits across a range of cognitive domains, and these deficits frequently persist for six
months or longer following remission. Cognitive deficits are associated with increased
relapse rates, less treatment compliance, and poorer treatment outcomes in individuals
seeking substance use treatment. Despite the high rates of cognitive impairments among adults
with AUDs and their negative impact on treatment outcomes, current evidence-based treatments
for AUDs do not specifically treat or address cognitive symptoms. Accessible (e.g., brief,
manualized, delivered via telehealth) and effective treatments for adults with AUDs and
cognitive deficits are urgently needed.
The primary objective of this study is to assess the feasibility and acceptability of a
manualized, 8-week, Compensatory Cognitive Training (CCT) intervention delivered via
telehealth for Veterans in early remission from alcohol use disorder (AUD).
The investigators hypothesize that Motivationally Enhanced Compensatory Cognitive Training
for Addictions (ME-CCT-A) will be feasible and acceptable in a pilot trial of ME-CCT-A
delivered via telehealth.
Description:
Motivationally Enhanced Compensatory Cognitive Training for Addictions (ME-CCT-A) is a
manualized group-based behavioral intervention (8 weeks, 2 hour per week) designed to improve
cognitive functioning in Veterans with substance use disorders (SUDs) and cognitive
complaints. ME-CCT-A is an adaptation of CCT initially developed by clinicians and
researchers at the VA Portland Healthcare System and VA San Diego Healthcare System. CCT
draws from the empirical and theoretical literature on compensatory strategy training for
conditions characterized by cognitive complaints and impairments, including mild traumatic
brain injury, psychosis, and mild cognitive impairment. ME-CCT-A is a comprehensive treatment
in that it addresses multiple types of symptoms and concerns that interfere with recovery
from addictions - cognitive impairments, neuropsychiatric symptoms, and lifestyle patterns
that increase risk of cognitive impairment, poor health, and relapse. In addition to training
in compensatory cognitive skills, ME-CCT-A includes mindfulness practices and motivational
interviewing techniques to boost the adoption of lifestyle strategies (e.g., nutrition,
exercise) that improve cognition and overall health. ME-CCT-A is designed to be easy to
administer and as an adjunct to standard SUD treatment programs. While initially designed to
be delivered in-person, ME-CCT-A can be delivered through virtual platforms with little to no
modification of the content and structure of the intervention.
Given the high rate of AUDs among Veterans, the prevalence of cognitive impairments among
those with AUDs, and the negative impact of cognitive impairments on treatment outcomes, an
evidence-based cognitive training intervention that optimally addresses the complex needs of
Veterans with AUDs and cognitive impairments is of critical importance. This study will allow
the investigators to optimize ME-CCT-A for the telehealth format and assess the feasibility
and acceptability of the intervention in preparation for a larger-scale pilot randomized
control trial.
