Clinical trial NCT06134128: Compensatory Cognitive Training Via Telehealth for Veterans with Alcohol Use Disorders
Official title: Compensatory Cognitive Training Via Telehealth for Veterans with Alcohol Use Disorders (CCT-A)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: cognitive rehabilitation
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Male and female Veterans (\>18 years) who meet criteria for AUD in early remission (\>1 month, \<12 months remission) based on the DSM-5 (American Psychiatric Association, 2013)
* Concern about a mild cognitive decline that has been identified by the Veteran or a knowledgeable informant (e.g., SUD treatment providers), and the Veteran wants treatment for their cognitive concerns
* Access to internet and webcam.

Exclusion Criteria:

* Intoxication or impaired capacity to understand study risks and benefits
* Major Neurocognitive Disorder, dementia, neurodegenerative disorder (e.g., Alzheimer's Disease)
* Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group or benefit from compensatory strategies

Primary outcomes:
measure: Recruitment rate
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Study retention
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Feasibility of testing procedures
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Feasibility of data collection methods
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Acceptability, by participant report
timeFrame: Measured after the 8-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
References: