Alcohol Use Disorder
Conditions
Keywords
cognitive rehabilitation
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.
Interventions
BEHAVIORALMotivationally Enhanced Compensatory Cognitive Training for Addictions Group
8-week manualized group-based behavioral intervention delivered via telehealth
Sponsors
Portland VA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | From enrollment to the end of treatment at 8 weeks | Number of participants included from eligible Veterans; satisfactory recruitment defined as enrolment of ≥ 50% of eligible Veterans. |
| Study Retention | From enrollment to the end of treatment at 8 weeks | Satisfactory retention rate ≥ 75% of participants completing the intervention. |
| Feasibility of Testing Procedures | From enrollment to the end of treatment at 8 weeks | % of participants where follow-up visit was completed. |
| Feasibility of Data Collection Methods | From enrollment to the end of treatment at 8 weeks | % of participants with complete data sets. |
| Acceptability, by Participant Report | Measured after the 8-week intervention | Satisfactory acceptability ≥ 70% of participants score ≥ 24 on the Client Satisfaction Questionnaire (CSQ-8). CSQ-8 scores range from 8-32, with higher scores indicating greater satisfaction with the intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Addictions Group 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. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Motivationally Enhanced Compensatory Cognitive Training for Addictions Group |
|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 14 |
| Education | 13.9 years STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Acceptability, by Participant Report
Satisfactory acceptability ≥ 70% of participants score ≥ 24 on the Client Satisfaction Questionnaire (CSQ-8). CSQ-8 scores range from 8-32, with higher scores indicating greater satisfaction with the intervention.
Time frame: Measured after the 8-week intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Addictions Group | Acceptability, by Participant Report | 15 participants' score ≥ 24 |
Primary
Feasibility of Data Collection Methods
% of participants with complete data sets.
Time frame: From enrollment to the end of treatment at 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Addictions Group | Feasibility of Data Collection Methods | 15 Participants |
Primary
Feasibility of Testing Procedures
% of participants where follow-up visit was completed.
Time frame: From enrollment to the end of treatment at 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Addictions Group | Feasibility of Testing Procedures | 15 Participants |
Primary
Recruitment Rate
Number of participants included from eligible Veterans; satisfactory recruitment defined as enrolment of ≥ 50% of eligible Veterans.
Time frame: From enrollment to the end of treatment at 8 weeks
Population: Thirty-two individuals expressed interest, and 29 completed screening; 19 Veterans enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Addictions Group | Recruitment Rate | 19 Participants |
Primary
Study Retention
Satisfactory retention rate ≥ 75% of participants completing the intervention.
Time frame: From enrollment to the end of treatment at 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Addictions Group | Study Retention | 15 Participants |