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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Addictions Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivationally Enhanced Compensatory Cognitive Training for Addictions Group | Behavioral | 8-week manualized group-based behavioral intervention delivered via telehealth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Number of participants included from eligible Veterans; satisfactory recruitment defined as enrolment of ≥ 50% of eligible Veterans. | From enrollment to the end of treatment at 8 weeks |
| Study Retention | Satisfactory retention rate ≥ 75% of participants completing the intervention. | From enrollment to the end of treatment at 8 weeks |
| Feasibility of Testing Procedures | % of participants where follow-up visit was completed. | From enrollment to the end of treatment at 8 weeks |
| Feasibility of Data Collection Methods | % of participants with complete data sets. | From enrollment to the end of treatment at 8 weeks |
| 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. | Measured after the 8-week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portland VA Medical Center | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Motivationally Enhanced Compensatory Cognitive Training for Addictions Group: 8-week manualized group-based behavioral intervention delivered via telehealth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Rate | Number of participants included from eligible Veterans; satisfactory recruitment defined as enrolment of ≥ 50% of eligible Veterans. | Thirty-two individuals expressed interest, and 29 completed screening; 19 Veterans enrolled in the study. | Posted | Count of Participants | Participants | From enrollment to the end of treatment at 8 weeks |
|
1 year
All adverse events were reported immediately to the Co-PIs who evaluated the patient and determined if any additional evaluation or treatment was needed. Co-PIs ensured that adverse events were properly reported to the IRB. The study staff examined all cumulative adverse events quarterly to determine if there were any systematic problems.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Motivationally Enhanced Compensatory Cognitive Training for Addictions Group: 8-week manualized group-based behavioral intervention delivered via telehealth |
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The small sample size reduced statistical power and generalizability, although this is consistent with early stage feasibility research.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Shirley, PhD | VA Portland Healthcare System | 503-220-8262 | 52470 | kate.shirley@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2024 | Nov 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Education | Years of education | Mean | Standard Deviation | years |
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| Primary | Study Retention | Satisfactory retention rate ≥ 75% of participants completing the intervention. | Posted | Count of Participants | Participants | From enrollment to the end of treatment at 8 weeks |
|
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| Primary | Feasibility of Testing Procedures | % of participants where follow-up visit was completed. | Posted | Count of Participants | Participants | From enrollment to the end of treatment at 8 weeks |
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| Primary | Feasibility of Data Collection Methods | % of participants with complete data sets. | Posted | Count of Participants | Participants | From enrollment to the end of treatment at 8 weeks |
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| 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. | Posted | Number | participants' score ≥ 24 | Measured after the 8-week intervention |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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