Compensatory Cognitive Training Via Telehealth for Veterans With Alcohol Use Disorders (CCT-A)
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Portland VA Medical Center

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Official Title: Compensatory Cognitive Training Via Telehealth for Veterans With Alcohol Use Disorders 
 
ClinicalTrials.gov Identifier (NCT Number): NCT06134128 
 
Date of Document: 5/24/2024 
 
Point of Contact: Kate Shirley 
VA Portland Healthcare System 
Phone:503-220-8262 ext. 52470  
Email:kate.shirley@va.gov 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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VAPORHCS Research Protocol/Local Protocol Addendum  
 
Title      
Compensatory Cognitive Training Via Telehealth for Veterans with Alcohol Use Disorders  
 
Investigators  
Kate Shirley, M.A. (Co-PI)  
Maya O’Neil, Ph.D. (Co-PI)  
Jennifer Loftis, Ph.D. (Co-I)  
Benjamin Morasco, Ph.D. (Co-I) 
 
Specific Aims/Purpose 
See sponsor/3rd party protocol for information in this section. Indicate what heading/subheading in 
the 3rd party protocol that the information is located:       
 
Prior research conducted by our team at the VA Portland Healthcare System (VAPORHCS) has 
demonstrated that Compensatory Cognitive Training (CCT) reduces cognitive problems and improves 
compensatory cognitive strategy use among Veterans with a history of mild traumatic brain injury 
(Pagulayan et al., 2017; Storzbach et al., 2017) and mild cognitive impairment (Huckans et al., 2013; 
Huckans et al., 2010). Motivationally Enhanced Compensatory Cognitive Training for Addictions (ME-
CCT-A) is a promising manualized cognitive rehabilitation therapy for addictions that was developed and 
piloted by the original developers of CCT (Huckans et al., 2018). This study extends our research by 
evaluating ME-CCT-A delivered via telehealth in the context of early remission from alcohol use disorder 
(AUD). The specific aims of the study include: 
 
Aim 1. Evaluate feasibility and acceptability in a pilot trial of ME-CCT-A delivered via telehealth in 
Veterans in early remission from AUDs. 
 
Hypothesis 1: We hypothesize that ME-CCT-A will be feasible and acceptable in a pilot trial of ME-
CCT-A delivered via telehealth.  
 
Aim 2. Assess the preliminary efficacy of ME-CCT-A delivered via telehealth on objective cognitive 
performance, daily functioning, subjective cognitive complaints, and psychiatric and substance use 
outcomes. 
 
Hypothesis 2: We hypothesize that ME-CCT-A will improve objective cognitive performance, daily 
functioning, subjective cognitive complaints, and psychiatric and substance use outcomes in 
Veterans in early remission from AUDs.  
 
Scientific Rationale and Significance  
 See sponsor/3rd party protocol for information requested in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
Alcohol use disorders (AUDs) are highly disabling yet treatable conditions that pose a significant burden 
to individuals and society due to the high rates of morbidity, mortality, and economic costs associated 
with the condition. Veterans are at elevated risk for developing AUDs due to high rates of trauma 
exposure, readjustment stressors, and heavy alcohol consumption normalized within military cultures 
(Meadows et al., 2022; Straus et al., 2020). AUDs are among the most common psychiatric conditions 

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nationally; the lifetime prevalence of AUDs is 29.1% with a 12-month prevalence of 13.9% (Grant et al., 
2015). Rates of AUDs are even higher among Veterans; the lifetime prevalence of AUDs for Veterans is 
35.8% with a 12-month prevalence of 15.1% (Boden & Hoggatt, 2018). According to the Centers for 
Disease Control, AUDs costs the United States $249 billion annually (Sacks JJ, 2015). The costs 
associated with AUDs are numerous, with the largest contributors being healthcare expenses, criminal 
justice expenses, losses to workplace productivity, and motor vehicle crashes (Rehm & Shield, 2019; 
Rehm, 2009; Sacks JJ, 2015). 
 
Despite the high prevalence and costs associated with AUDs, treatment rates for the general population 
remain low with only 17.3% of people with AUDs receiving treatment, indicating a treatment gap of 
82.7% (Mekonen et al., 2021). For those who enter treatment, relapse rates for current substance use 
treatment programs remain very high (~40-60%), often with more than half of individuals relapsing within 
six months of completing treatment (Moos & Moos, 2006; NIDA, 2020). Treatment rates for AUD within 
the VA are slightly higher, with approximately 25% of Veterans with an AUD receiving specialty 
addictions treatment for AUD (Williams et al., 2021). 
 
Telehealth can play a considerable role in increasing access to evidence-based treatments for Veterans 
with AUDs. The US Department of Veterans Affairs (VA) has expanded access to virtual visits (i.e., VA 
Video Connect) throughout the COVID-19 pandemic (Connolly et al., 2021). From February 2020 to 
November 2020, weekly telehealth visits increased by 1,653% with over 40,000 telehealth visits 
completed daily (US Department of Veteran Affairs, 2021). Preliminary research indicates that there is 
little difference between evidenced-based treatments (EBTs) delivered in-person versus via telehealth 
(Fiacco et al., 2021; Lin et al., 2019; Shigekawa et al., 2018; Young, 2012). A recent rapid review of 
telehealth for SUDs highlighted strong support for telehealth as an addition to standard care, as it 
improved abstinence from alcohol and increased treatment retention (Uhl et al., 2022).  A systemic 
review of group-based treatments delivered via telehealth indicated high patient and provider satisfaction 
and showed similar outcomes to in-person groups (Gentry et al., 2019). Telehealth can eliminate 
barriers to Veterans accessing EBTs and has many documented advantages, including improved 
access to EBTs, cost effectiveness, convenience, greater retention of materials, time saving effects, 
greater privacy, and increased flexibility for both Veterans and providers (Elnitsky CA, 2013; Frost et al., 
2022; Kintzle et al., 2022).  
 
Most individuals entering treatment for AUDs present with cognitive deficits across a range of cognitive 
domains, including attention, memory, and executive functions, and these deficits frequently persist for 
six months or longer following remission (Bruijnen et al., 2019; Glass et al., 2009; Le Berre et al., 2017; 
Stavro et al., 2013). Cognitive deficits are associated with increased relapse rates, less treatment 
compliance, and poorer treatment outcomes in individuals seeking substance use treatment (Czapla et 
al., 2016; Mahoney, 2019; Schmidt et al., 2017). Despite the high rates of cognitive impairments among 
adults with AUDs and their negative impact on treatment outcomes, current evidence-based 
pharmacotherapies and behavioral treatments for AUDs do not specifically treat or address cognitive 
symptoms. Accessible (e.g., brief, manualized, delivered via telehealth) and effective treatments for 
Veterans with AUDs and cognitive deficits are urgently needed. 
 
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 (Storzbach et al., 2017). 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 (Storzbach et al., 2017), psychosis 

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(Twamley et al., 2012), and mild cognitive impairment (Huckans et al., 2010). 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 (Miller, 2013) to boost the adoption of lifestyle strategies (e.g., nutrition, exercise) that 
improve cognition and overall health (Gomez-Pinilla, 2006). 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.  
 
VA-SPECIFIC REQUIREMENT (relevance to VA mission):  
 See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
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. To our knowledge, no studies have been conducted 
to evaluate the efficacy of a telehealth-delivered, manualized comprehensive compensatory cognitive 
training intervention with Veterans with addictions and cognitive deficits. This study will allow us to 
optimize ME-CCT-A for the telehealth format and assess the feasibility, acceptability, and preliminary 
efficacy of the intervention in preparation for a larger-scale pilot randomized control trial.     
 
Preliminary Studies 
 See sponsor/3rd party protocol for information requested in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
Ms. Shirley (Co-PI) has extensive training and experience in conducting, pilot testing, and publishing 
studies on CCT with Veterans. Ms. Shirley’s research and clinical experiences have informed her 
knowledge of the importance of utilizing neuropsychological assessment and evidence-based treatments 
in the management of cognitive impairment across a range of conditions, such as mild cognitive 
impairment (MCI), traumatic brain injury (TBI), post-traumatic stress disorder (PTSD), and substance 
use disorders (SUDs). From 2018 to present, Ms. Shirley has served as the study clinician administering 
the clinical protocol of a multi-site VA-funded randomized control trial that evaluates the efficacy of CCT 
for Veterans with MCI (O’Neil, IRB#4101). She has collected pilot data on CCT in Veterans with 
substance use disorders alongside one of the originators of CCT, Marilyn Huckans, PhD (O’Neil, 
IRB#4018). In addition to expertise in CCT, Ms. Shirley’s research has examined the adverse 
psychiatric, cognitive, and physical health effects following chronic use and during protracted abstinence 
from SUDs. From 2018 to present, she has served as study coordinator of a project investigating brain 
dysfunction in Veterans with AUDs following treatment for Hepatitis C (Loftis, IRB#3967). She has 
analyzed data collected by the Methamphetamine Use Research Center (MARC) and published multiple 
manuscripts examining differences in cognition, psychiatric symptoms, and physical health during active 
use and remission from methamphetamine (MA) and opioids. This project is a logical extension of her 
interest and experience in cognitive rehabilitation interventions and years of collaboration with the 
Compensatory Cognitive Training Research Program (led by her academic/research mentor, Maya 
O’Neil, PhD [Co-PI]) at VAPORHCS and OHSU.  
 

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Ms. Shirley’s recent published work related to CCT and SUDs are noted below: 
1. Shirley, K., Sano, E., & O’Neil, M. (2023). Pilot trial of Compensatory Cognitive Training with 
Veterans in Remission from Alcohol Use Disorders. Abstract selected for poster presentation at 
the Annual RSA Scientific Meeting, Bellevue, Washington.  
2. Loftis, J.M., Firsick, E., Shirley, K., Le-Cook, A., Sano, E., Hudson, R., & Moorman, J. (2023). 
Inflammatory and Mental Health Sequelae of COVID-19. Comprehensive 
Psychoneuroendocrinology (Under Review). 
3. Shirley, K., O’Neil, M., Boyd, S., & Loftis, J.M. (2023). Differences in Rates of Impairment in 
Adults Who Use Methamphetamine Using Two Sets of Demographically Corrected Norms. 
Applied Neuropsychology: Adult.  
4. Shirley, K. & Loftis, J. M. (2022). A Spotlight on HCV and SARS-CoV-2 Co-infection and Brain 
Function. Pharmacology, Biochemistry and Behavior. 
5. Shirley, K., Firsick, E., Sano, E., O’Neil, M., & Loftis, J. (2022). Comparison of Self-Reported 
Psychiatric Symptom Severity in Adults Who Use Methamphetamine Versus Methamphetamine 
and Opioid Co-use. Abstract selected for poster presentation at the Association for Psychological 
Science Annual Convention, Chicago, Illinois.   
6. Shirley, K., O’Neil, M., & Loftis, J. (2022). Potential for Inflated Norms in Neuropsychological 
Assessment of Individuals Who Use Methamphetamine. Abstract selected for poster presentation 
at the International Neuropsychological Society 50th Annual Meeting, New Orleans, Louisiana.  
7. Huckans, M., Boyd, S., Moncrief, G., Hantke, N., Winters, B., Shirley, K., Sano, E., McCready, 
H., Dennis, L., Kohno, M., Hoffman, W., & Loftis, J. (2021). Cognition during Active 
Methamphetamine Use Versus Remission. Journal of Clinical and Experimental 
Neuropsychology.  
8. O'Neil, M. E., Cameron, D., Shirley, K., Sano, E., Twamley, E., Williams, R., Turner, A., 
Pagulayan, K., Roost, M., Jak, A., Storzbach, D., & Huckans, M. (2021). Change in Learning and 
Memory Partially Mediates Effects of Compensatory Cognitive Training on Self-Reported 
Cognitive Symptoms. Journal of Head Trauma Rehabilitation. 
9. Loftis, J., Firsick, E., Shirley, K., & Hoffman, W. (2021). Effects of Alcohol Use Disorder and 
Chronic Viral Infection on Neurocircuitry and Behavior. Abstract selected for oral presentation 
(given by Loftis) at the Psychiatric Research Society Annual Meeting, Park City, Utah. 
 
Dr. Maya O’Neil’s (Co-PI) research focuses on treatment, assessment, and health services related to 
PTSD and TBI, as well as common comorbidities, such as cognitive impairment. Dr. O’Neil is currently 
funded on a 5-year career development award (CDA) through the VA’s rehabilitation research and 
development program piloting the efficacy and feasibility of CCT for PTSD (O’Neil #3500). In addition, 
Dr. O’Neil is the site primary investigator of a multi-site, VA-funded, randomized control trial that 
evaluates the efficacy of CCT for Veterans with MCI (O’Neil #4101) as well as a principal- and co-
investigator on numerous grants that investigate cognitive functioning and mental health. Dr. O’Neil has 
worked closely and collaborated with the developers of CCT on multiple projects and papers.  
 
Dr. O’Neil’s recent published works related to CCT are noted below: 
 
 
1. Keller, A.V., Clark, J.M.R., Maye, J.E., Jak, A.J., O’Neil, M.E., Williams, R.M., Turner, A.P., 
Pagulayan, K.F., & Twamley, E.W. (2023). Neuropsychological predictors of posttraumatic 
stress disorder and depressive symptom improvement in compensatory cognitive training for 
Veterans with a history of mild traumatic brain injury. Abstract selected for poster presentation at 
the 51st Annual Meeting of the International Neuropsychological Society, San Diego, CA. 
2. Clark, J.M.R., Mahmood, Z., Jak, A.J., Huckans, M., O’Neil, M.E., Roost, M., Williams, R.M., 
Turner, A.P., Pagulayan, K.F., Storzbach, D., & Twamley, E.W. (2022). Neuropsychological 

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performance and functional capacity following mild traumatic brain injury in Veterans. Journal 
of Head Trauma Rehabilitation. 
3. Clark, J.M.R., Keller, A.V., Maye, J.E., Jak, A.J., Huckans, M., O’Neil, M.E., Roost, M.S., 
Williams, R.M., Turner, A.P., Pagulayan, K.F., Storzbach, D., & Twamley, E.W. (2021). 
Neuropsychological predictors of posttraumatic stress disorder and depressive symptom 
improvement in compensatory cognitive training for Veterans with a history of mild traumatic 
brain injury. Journal of Head Trauma Rehabilitation. 
4. O’Neil, M.E., Cameron, D.C., Shirley, K., Sano, E., Twamley, E., Williams, R., Turner, A., 
Pagulayan, K., Roost, M., Jak, A., Storzbach, D., Huckans, M. (2021). Change in learning and 
memory partially mediates effects of compensatory cognitive training on self-reported cognitive 
symptoms. Journal of Head Trauma Rehabilitation. 
5. Mahmood, Z., Clark, J.M.R., Jak, A.J., Huckans, M., O’Neil, M.E., Roost, M.S., Williams, R.M., 
Pagulayan, K.F., Turner, A.P., Storzbach, D., & Twamley, E.W. (2020). Predictors of 
intervention adherence in compensatory cognitive training for Veterans with a history of mild 
traumatic brain injury. Journal of Head Trauma Rehabilitation. 
6. Clark, J.M.R., Mahmood, Z., Huckans, M., O’Neil, M.E., Jake, A.J., Williams, R.M., Turner, 
A.P., Pagulayan, K.F., Roost, M.S., Callahan, M.L., Storzbach, D.M., & Twamley, E.W. (2019). 
Correlates of PTSD symptom improvement in Veterans with a history of mild traumatic brain 
injury receiving compensatory cognitive training. Abstract selected for poster presentation at the 
14th Annual Lewis L. Judd Young Investigators Symposium, UCSD Department of Psychiatry, 
La Jolla, CA.  
7. O’Neil, M.E., Pagulayan, K.*, Turner, A., White, R., Laman-Maharg, B., Storzbach, D., 
Twamley, E., (2017). Mental health does not moderate compensatory cognitive training 
efficacy for Veterans with a history of mild traumatic brain injury. Archives of Physical Medicine 
and Rehabilitation. [*Shared first authorship] 
8. Storzbach, D., Twamley, E., Roost, M., Golshan, S., Williams, R., O’Neil, M.E., Jak, A., 
Turner, A., Kowalski, H., Pagulayan, K., Huckans, M. (2016). Compensatory cognitive training 
for Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn 
(OEF/OIF/OND) Veterans with mild traumatic brain injury. Journal of Head Trauma 
Rehabilitation. 
 
Research Design and Methods  
 See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
Overview: We will enroll up to 30 Veterans and assess feasibility, acceptability, and preliminary 
efficacy of ME-CCT-A via telehealth. Veterans will receive ME-CCT-A via telehealth and undergo two 
study evaluations (baseline and 8 weeks) while also continuing with their usual medical, psychiatric, 
psychotherapeutic, and/or substance use treatment. Feasibility will be assessed by examining data 
on recruitment and retention rates, rate of completion of the intervention, and feasibility of testing 
procedures and data collection methods. Acceptability will be assessed through feedback surveys 
after study completion. We will assess the preliminary efficacy of ME-CCT-A on objective cognitive 
performance, daily functioning, subjective cognitive complaints, and psychiatric and substance use 
outcomes.  
 

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Intervention: Once at least 4 eligible Veterans have completed 
baseline visits, the 8-week group will begin via telehealth. The virtual 
group will be held through VA Video Connect or another VA-
approved video meeting tool. Group sessions will last for 2 hours 
and consist of interactive didactic information and discussion and 
activities that introduce a variety of cognitive strategies and external 
aids. Ms. Shirley (Co-PI) and/or another study staff member will run 
the CCT groups. Intervention materials will be mailed to participants 
prior to group start date. Attendance of each Veteran at each 
session will be noted. Individual make-up sessions will be offered to 
Veterans who miss a session, and attendance at make-ups will be 
recorded. 
 
ME-CCT-A Treatment Manual: The structure of the intervention is 
determined by the ME-CCT-A treatment manual, which has been 
tailored to each cognitive domain commonly affected by SUDs 
(Huckans et al., 2018). Session materials correspond to 
compensatory cognitive training for difficulties with learning, 
memory, processing speed, executive functioning (multitasking 
abilities), verbal functioning, concentration, and attention. 
Additionally, session content in the updated manual is tailored to 
address other symptoms related to SUDs that might be influencing cognitive functioning and 
incorporates motivational interviewing methods. Table 1 outlines the structure and content of the ME-
CCT-A treatment manual and group sessions. 
 
 
Assessment Protocol: Veterans will complete the virtual assessment battery (see Table 2) at 
baseline (approximately 0-2 weeks prior to ME-CCT-A) and follow-up (approximately 0-2 weeks 
following ME-CCT-A completion). The battery consists of performance-based tests of objective 
cognition functioning and functional capacity and self-report measures of subjective cognitive 
complaints/functioning, substance use, engagement in targeted lifestyle practices associated with 
improved cognition, and engagement in protective activities/factors associated with reduced relapse. 
The Client Satisfaction Questionnaire (CSQ-8) and a series of structured, open-ended questions 
specific to the study intervention will be included at follow-up to assess Veterans’ satisfaction with the 
virtual CCT intervention. Assessments will take approximately 2 hours.   
 
Table 1. ME-CCT-A Session Content 
Session  
Major Concepts 
Examples of Strategies  
Session Activities 
Home Exercise 
1 
Intro and SUD/cognitive functioning 
psychoeducation 
Creating a “home” for important 
items 
Day planner use 
Finding a home for the day 
planner 
2 
Organization and prospective 
memory Part I 
Time management 
Scheduling and concrete goal 
setting 
Practice using the calendar 
3 
Organization and prospective 
memory Part II 
Daily and weekly planning 
sessions 
Enter lists and activities into 
the calendar 
Follow through with planning 
sessions 
4 
Attention and concentration 
Paying attention during 
meetings and conversations 
Practicing paying attention 
during conversations 
Active listening once a day 
5 
Learning and memory 
Internal and external memory 
strategies 
Practice memory strategies 
Practice using a strategy 
everyday 
6 
Problem-solving and cognitive 
flexibility 
Evaluating costs and benefits to 
identify better choices 
6-step problem-solving method 
Practice problem-solving 
with 2 life goals 
7 
Planning and goal setting 
Goal setting 
Identify and re-evaluate 
priorities  
Practice planning a goal 
8 
Skill integration and review 
Review, practice, goals, and 
planning for the future 
How to maintain skills and 
apply them to goals 
Provided with additional 
SUD-related resources  
Study Activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening Visit 
Duration: 30 minutes 
• 
Phone Screening 
• 
Medical Record Review 
Baseline Visit (0-2 weeks prior to 
ME-CCT-A) 
Duration: 3 hours 
• 
Informed Consent 
• 
Assessment Protocol 
ME-CCT-A  
Duration: 2 hours per week for 8 weeks 
Follow-Up Visit   
(0-2 weeks after ME-CCT-A 
completion) 
Duration: 2 hours 
• 
Assessment Protocol 

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The cognitive domains were selected for assessment because previous research by our group has 
demonstrated that SUDs can be associated with significant impairments in attention, memory, and 
executive functions, and because ME-CCT-A includes cognitive strategy training that specifically 
targets each of those domains (Huckans et al., 2021; Huckans, Fuller, Wheaton, et al., 2015; 
Huckans, Fuller, Chalker, et al., 2015; Huckans et al., 2010; Storzbach et al., 2017). Measures were 
selected because of their sound psychometric properties and their ability to be conducted virtually. 
Each neuropsychological measure has more than one form, minimizing test-retest confounds at our 
two assessment visits. Assessment measures will be scored according to standardized test 
procedures. All assessments will be administered by Ms. Shirley (Co-PI) or another approved study 
member and supervised by Maya O’Neil, Ph.D. (Co-PI), who is a licensed, credentialed, and 
privileged VA neuropsychologist.  
 
Table 2. Assessment Protocol  
 
Measure 
Construct Assessed 
Objective Cognitive Functioning and Functional Capacity (Neuropsychological Tests) 
Wide Range Achievement Test 5 (WRAT5)  
Reading ability, premorbid IQ estimate (baseline only) 
Neuropsychological Assessment Battery (NAB) Attention Module subtest: Digit Span 
Auditory attention capacity and working memory 
NAB Attention Module subtest: Driving Scenes 
Visual attention and working memory 
NAB Memory Module subtest: List Learning 
Verbal learning and memory 
NAB Memory Module subtest: Shape Learning 
Visual learning and memory 
NAB Memory Module subtest: Medication Instructions  
Verbal learning and memory relevant to everyday functioning 
NAB Memory Module subtest: Name, Address, and Phone Number 
Verbal learning and memory relevant to everyday functioning 
NAB Executive Functions Module subtest: Judgment 
Everyday problem-solving/executive function 
NAB Executive Functions Module subtest: Categories 
Mental flexibility and categorization 
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency  
Language 
Self-report Measures (Questionnaire Battery) 
Brief Addiction Monitor (BAM) 
Substance use factors; Risk/protective factors 
Prospective-Retrospective Memory Questionnaire (PRMQ) 
Cognitive symptoms 
Portland Cognitive Strategies Scale 2.0 (PCSS) 
Compensatory cognitive strategy use 
PROMIS–57 Profile v2.1 
Physical, mental, and social health  
PROMIS v2.0 Cognitive Function 8a 
Subjective cognitive functioning 
Client Satisfaction Questionnaire (CSQ-8) 
Satisfaction with the intervention (follow-up only) 
Timeline Followback (TLFB) 
Alcohol and cannabis consumption over a given time period 
Alcohol Use Disorders Identification Test (AUDIT-C) 
Alcohol use 
 
ANALYTIC PLAN. 
All data analyses will be conducted by study personnel with expertise in statistics, using Excel, SPSS, 
or other statistical software approved by the VA. 
 
Phase 2, Aim 2 Feasibility and Acceptability: Descriptive statistics will characterize the feasibility of 
recruiting and retaining Veterans. Recruitment will be deemed feasible if we successfully screen for 
eligibility 50% of Veterans referred to the study and enroll 75% of screened Veterans who meet all 
study inclusion criteria. Retention will be deemed successful if we achieve 75% completion for post-
treatment assessments. Chi-square tests of association and t-tests will compare demographic and 
clinical characteristics of successfully versus unsuccessfully recruited and retained Veterans to 
identify characteristics of Veterans who may require more intensive recruitment or retention efforts in 
a future trial. Acceptability will be assessed through surveys on treatment satisfaction (i.e., CSQ-8 
with additional study-specific items) following group completion. Treatment will be deemed acceptable 
if ≥ 70% of Veterans score ≥ 24 on the CSQ-8.  
 
Phase 2, Aim 3 Preliminary Efficacy: Descriptive statistics and exploratory analyses will be used to 
assess the normality of the data and homogeneity of variance. Although our small sample size will 
limit our power to detect significant differences between pre- and post-treatment measures, we will 

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conduct preliminary analyses using t-tests to examine whether pre-post changes are in the expected 
directions. We will examine effect size (Cohen’s d) and significance of our measures. 
 
Study Population 
 See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
The proposed study is conducted at a single site. We propose to enroll up to 30 Veterans in this pilot 
trial. Because our primary purposes are to examine feasibility and acceptability to Veterans with AUD, 
achieving adequate statistical power is not a primary concern of this pilot clinical trial. Results from this 
study with a sample size of up to 30, combined with comparisons to similar studies of CCT with other 
Veteran groups (e.g., those with mild TBI history), will provide adequate information on expected effect 
size to allow for estimations of statistical power for a future proposal of a larger pilot trial.  
 
Inclusion criteria include:1) 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); 2) 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; and 3) Access to internet and webcam.  
 
Exclusion criteria include: 1) Intoxication or impaired capacity to understand study risks and benefits; 2) 
Major Neurocognitive Disorder, dementia, or neurodegenerative disorder (e.g., Alzheimer’s Disease); 
and/or 3) Auditory or visual impairments that would prevent ability to participate in the cognitive 
rehabilitation group or benefit from compensatory strategies.  
 
Eligibility will be established by electronic medical record review and will be confirmed by the Veteran 
during the initial phone call. 
 
1. VA-SPECIFIC REQUIREMENT (inclusion of non-Veterans):  
N/A. The study does not include non-Veterans. 
 See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
Subject Identification/Recruitment 
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heading/subheading in the 3rd party protocol that the information is located:   
 
 
Recruitment, eligibility screening, consenting, study visits, and CCT groups will be conducted by 
approved clinical research staff. A Waiver of Authorization and Informed Consent Process for 
Screening/Recruitment Purposes will be obtained to facilitate subject identification and recruitment.  
 
1. Potential participants who meet the study criteria will be recruited into this study through word-of-
mouth referrals from clinicians at VAPORHCS, primarily through the neuropsychology clinic, SUD 
treatment program, and outpatient mental health clinic. Study announcements and study 
advertisements will be disseminated to mental health and SUD providers at VAPORHCS to assist 
with recruitment. Research staff may contact patients who indicate to their clinicians that they are 
interested in participating. Potential participants may also contact the study personnel after learning 

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of the study (e.g., from advertisements). Initial phone screening will be done for each subject when 
they contact the lab and are interested in participating. The potential participant will be screened by 
study personnel using a screening form. A study member will give regular presentations of the 
study at Substance Abuse Treatment Program (SATP) access meetings. Attendance at these 
recruitment meetings by potential subjects is entirely voluntary. Potential subjects will be given the 
IRB-approved advertisement with contact information and asked to call the contact number if they 
are interested in participation.  
2. IRB-approved flyers will be posted in designated research advertisement space at VAPORHCS, 
which includes elevators and lobby spaces, as well as common spaces at OHSU and in the 
community.  
3. Social media will be utilized for recruitment purposes. Study advertisements will be posted on 
VAPORHCS sponsored social media accounts including internal publication/promotion (Weekly E-
news employee newsletter and Employee SharePoint E-Post) and external publication/promotion 
(VA Social Media Sites including VAPORHCS Facebook and Twitter pages, Public VAPORHCS 
Web Page, Quarterly Veteran Connection Newsletter, and Email Updates through GovDelivery). All 
recruitment advertisements will ask prospective participants to telephone research staff if they are 
interested in participating. Email or social media messaging will not be utilized. Craigslist will also 
be utilized for recruitment. The study coordinator will create Craigslist postings that include a text 
version of the IRB approved study advertisement. Email responses to the Craigslist posting will be 
disabled so subjects will only be able to respond via telephone. All potential participants will be 
screened using the screening form when they contact research staff.   
4. The Corporate Data Warehouse (CDW) will be utilized to compile a list of potential participants. 
IRB-approved study staff will use this list to conduct medical chart reviews (i.e., CPRS) to identify 
Veterans who meet study criteria, do not meet exclusion criteria, are able to provide informed 
consent, can attend visits virtually, and may be interested in participating in the research. Veterans 
who are identified as eligible will be sent a letter from the Mental Health Clinical Director, a letter of 
introduction from the study team, the study flyer, and a form with the option to opt-in or opt-out to 
hearing more about the research either by calling study staff or returning the enclosed opt-in/opt-
out form. A self-addressed, postage-paid return envelope will be included for the Veteran’s 
convenience. The letter will also state that if study staff does not receive a response within two 
weeks, the Veteran may be contacted by phone to verify receipt of the letter and be given the 
option to be mailed a second letter (if not received). Only verification of Veteran’s address will be 
obtained for those who did not receive a letter. Study staff will call all Veterans who indicate 
interest to provide more information about the study, answer any questions the Veteran may have, 
and, if applicable, schedule the initial baseline visit. 
 
An appointment confirmation letter will be mailed to a participant after they have scheduled their initial 
visit. An appointment confirmation letter will also be sent prior to their follow-up visit. If a participant is 
enrolled in the study and not returning phone calls to schedule additional research visits, a no-show 
letter will be sent in the mail asking the participant to contact the research coordinator to discuss their 
interest in their continued involvement in the research study. If the research coordinator does not hear 
back from the participant within two weeks of sending the letter, the participant will be disenrolled 
from the research study. 
 
Inclusion of women and minorities in this pilot study is appropriate and is encouraged. Subject selection 
is based only on the criteria described in the subject eligibility section. Women and minorities are not 
excluded from the study solely based on either of those demographic characteristics. Because sex 
effects may be observed, we will make every effort to enroll equal numbers of men and women. Given 
that all research participants will be Veterans treated within the VAPORHCS, children will not be 
included in this study. 

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Informed Consent & HIPAA Authorization 
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
The procedure for collecting informed consent and HIPAA authorization will be conducted via phone, 
video, mail, or secured/encrypted email as described in these steps: 
  
Preliminary eligibility and screening phone call: For Veterans who are recruited into this study through 
referrals from clinicians, word of mouth at VAPORHCS, or after seeing a study flier, the research 
team members will conduct a chart screen and phone call to determine preliminary eligibility.  Eligible 
participants who have given their permission during the screening call with a study staff member will 
be informed to expect a packet in the mail or electronically via DocuSign. Potential participants will be 
advised of potential risks when returning signed documents through the mail. A packet containing the 
Informed Consent Form, HIPAA, subject reimbursement forms, and self-report measures will be sent 
to their home address (along with a self-addressed, stamped envelope [SASE]) or sent via DocuSign. 
Informed consent will either be obtained at the end of this call or conducted during a separate pre-
arranged phone or video appointment. The packet will contain a reminder for the recipient to not sign 
the documents prior to their next scheduled contact time with study staff. 
  
Informed consent: During the phone call or video visit with research personnel, the research team 
member will review the Informed Consent Form with the participant. Participants will be informed that 
they are being asked to participate in a research study. They will be told the nature of the procedures 
and informed of the risks associated with their participation, asked to read the consent form, and 
encouraged to ask questions or discuss any pertinent issues. Participants will be informed that the 
research project is voluntary, that participation can be stopped at any time and that participation will 
not impact any care, services, employment, or benefits they receive at the VAPORHCS. Participants 
will also be informed that they will be compensated for time. All research volunteers will be asked to 
sign the consent form and HIPAA authorization after they have read it and discussed the study with 
research personnel. If they give verbal consent to participate, they will be instructed to sign the ICF 
and HIPAA form. Veterans will be provided instructions for returning signed documents via DocuSign. 
Alternatively, participants have the option to place the signed forms into the SASE and mail back as 
soon as possible. For participants who choose to return the signed forms by mail, research data will 
be collected from the participant prior to the study team receiving the signed informed consent forms 
and HIPAA authorization. Participants may withdraw their consent at any time and may withdraw from 
the study at any time. 
 
4. VAPORHCS-SPECIFIC REQUIREMENT (inclusion of those with impaired decision-making 
capacity): 
N/A. The study does not include those with impaired decision-making capacity 
  
 
Risks and Side Effects: 

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See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
Patients may become upset or experience cravings for nicotine, drugs, or alcohol while answering 
personal questions during the interview and assessment. Participants may also become bored, 
fatigued, frustrated, or upset while completing cognitive tasks or questionnaires. There are also risks 
to confidentiality, particularly of sensitive information about alcohol and drug use and abuse. 
 
This is a low-risk study. Benefits to society include advancing research on a potentially efficacious 
treatment for Veterans with cognitive impairments in recovery from addictions. There are currently no 
FDA-approved medications for cognitive impairments due to AUD, and there are currently few, if any, 
manualized behavioral therapies for adults with cognitive impairments during recovery from AUD. Thus, 
the potential large benefits to society outweigh the potential minimal risks to subjects in this study. 
 
Since study activities involve contact with participants via telephone or video, study team members will 
only contact Veterans from a private area so no one outside of the study team can overhear the 
conversation or have access to research information or protected health information. The study team 
member that conducts a study activity via telephone or video will obtain the address of the Veteran's 
location where they will participate and the contact information of a person at or near the Veteran's 
location who can be called in the case of emergency. If there is not a person at or near the Veteran’s 
location available in case of emergency, the study team member will notify the Veteran that they will call 
911 if there is an emergency and provide the 911 dispatch with the Veteran’s address.  Veterans will 
participate via phone or video only if they have a safe, private location from which to participate. No 
video or audio recordings will be made during any of the research procedures.  
 
Neuropsychological measures are considered intellectual property and one of the risks of administering 
them through telehealth is a possibility of unauthorized reuse or sharing of the measures. To protect 
neuropsychological intellectual property, study staff will inform Veterans at the beginning of each 
assessment session that they cannot record or otherwise preserve test stimuli shown over the computer. 
 
Additional Participant Safeguards: 
 N/A. The study does not include vulnerable populations and/or those with impaired decision-making 
capacity. 
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
VAPORHCS-SPECIFIC REQUIREMENT (inclusion of those with impaired decision-making 
capacity): 
 N/A. The study does not include those with impaired decision-making capacity  
 
Suicidality: 
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
VA-SPECIFIC REQUIREMENT:  

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N/A. The study does not include a population of subjects who are potentially suicidal. 
 
If participants present with high risk for suicide (e.g., report suicidal plans or intentions), study staff 
will follow the following protocol, one step at a time until the participant is transferred to an 
appropriate provider for follow-up assessment and care: 1) Contact Maya O’Neil, PhD (Co-PI) or 
other IRB-approved responsible clinician of the study to assess the participant and determine if 
follow-up care is needed (e.g., open up virtual “room” for responsible clinician to join the video and 
ensure connection is established before ending the study visit). 2) Work with the participant to 
identify and contact the primary VA mental health or medical provider so the s/he can conduct an 
assessment and provide follow-up care as needed (i.e., alert provider by phone, through Teams, 
or encrypted email and send request for provider to join the call). 3) Use the emergency 
procedures for VVC to connect the participant to e911 services or contact local emergency 
services if the participant is not in an area in which 911 is available. 
 
Benefits:  
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
This study involves an intervention that may directly benefit the participants. There are general benefits 
to science and medicine in that the knowledge gained from this study may help to validate a new 
evidence-based treatment for individuals who are suffering from cognitive impairment due to AUD. 
Additionally, participants may benefit from the study if abnormal results are discovered through the study 
procedures (e.g., undiagnosed depression) and the participant is then referred to a provider for follow-up 
care. This study has the potential to benefit Veterans by improving our understanding of cognitive 
rehabilitation interventions for Veterans with AUDs.  
 
Protected Health Information:  
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
VA-SPECIFIC REQUIREMENTS:  
 
As part of the study, we will collect the following individually identifiable health information from each 
participant: information from their VA Health Records such as diagnoses, progress notes, medication, 
lab and radiology findings; specific information concerning alcohol and drug abuse and HIV status; 
demographic information such as name, race, gender, age, birthdate, address, phone number, and 
clinic visit dates; questionnaires and neuropsychological measures. This information is necessary for 
our research because we plan to use medical record information to confirm eligibility and clinical 
participation in CCT. We will use contact information to reach participants and for scheduling. We will 
use demographic information to describe our sample (i.e., sample characteristics) and to determine if 
they moderate study outcomes. Questionnaires and neuropsychological measures will help us 
determine if CCT is efficacious and address our study aims.  
 
Collaborative Research 
 
VA-SPECIFIC REQUIREMENTS:  
 N/A. The study does not include Collaborative Research. 

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This study is being reviewed by OHSU-VA joint IRB and utilizes OHSU’s REDCap. All study procedures 
are conducted on VAPORHCS property by VA staff on VA time. 
 
Resources Available 
VA-SPECIFIC REQUIREMENT:    
 
All research study visits are conducted through phone or video, but the Co-PIs’ existing research spaces 
(Portland campus: Bldg. 104, P3, Rooms B2G-151 and B2G-153; Building 103, Room E-136) may be 
utilized to conduct the remote research study visits. Study staff will utilize video-capable computers 
either in the Co-PI’s personal office/research spaces or from secure locations in their own homes. 
 
This project is a logical extension of Ms. Shirley (Co-PI), Dr. O’Neil (Co-PI), and Dr. Loftis’ (Co-I) existing 
research programs, which focus on the effects of SUDs and the development of novel treatments for 
cognitive impairment. Pilot data from this study will be used to submit future VA and NIH grants. Thus, it 
is reasonable that Ms. Shirley, Dr. O’Neil, and Dr. Loftis will be using a small portion of their own 
protected research time, research staff’s time, and their research space on this pilot project so that they 
may obtain continued funding for their research programs.  
 
Notably, similar interventions are currently regularly offered to Veterans at VAPORHCS, including 
Veterans with MCI, TBI, and PTSD through the neuropsychology clinic as part of normal clinical care.  
Whereas in the past these groups were offered to patients by VA-paid clinicians, this project will now 
enable research-funded staff to offer the same groups to patients (likely freeing up clinicians for 
additional clinical work). Thus, this project offers important clinical services to Veterans at VAPORHCS 
as a benefit to the hospital. However, because there is not sufficient data in the literature to know 
whether these interventions are effective with adults with AUD, we are offering them for research 
purposes only, rather than as standard clinical care.    
 
Subject Compensation/Payment: 
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
VA-SPECIFIC REQUIREMENTS: 
N/A. The study does not include subject compensation/payment. 
 
Subjects will be reimbursed $50 for the initial baseline assessment visit. Subjects who participate in the 
follow-up visits will receive an additional $50. Payment will be provided in the form of an Amazon.com 
gift card. This compensation is reasonable and commensurate with the expected contributions of the 
participant. The amount of payment and terms of the payment are described in the informed consent 
form. Payments are fair and appropriate and do not constitute (or appear to constitute) undue pressure 
or influence on, or coercion of, the prospective research subjects to volunteer for or continue 
participation in the research study. 
 
Privacy and Confidentiality: 
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 

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All study data derived from subject procedures will be obtained specifically for research purposes. 
Research records will be maintained according to the VA research records retention schedule. Data 
will be stored in a manner intended to preserve patient confidentiality. Hard-copy protected health 
information (PHI) will be stored in locked cabinets in the PIs’ VA office and laboratory space. 
Electronic PHI will be stored on servers behind the VA firewall accessed by password-protected VA 
computers. Each subject is assigned a unique identifier (study ID) based on a study identifier and 
number (i.e., CCTA-xxx). Only coded or de-identified data, not PHI, are used for analysis. The file 
linking the study ID to the patient’s name will be stored in a separate password-protected file on a 
secure server behind the VA firewall.  
 
Coded data will be stored on OHSU's REDCap application, a highly secure and robust web-based 
research data collection and management system. No identifiable information will be entered into this 
application at any time. The statisticians will not have access to the code or PHI at any time. The 
spreadsheet linking the code to the subject will remain behind the VA firewall at VAPORHCS. Once 
the study has ended, the link will be stored by the VAPORHCS Research & Development Service.  
 
Data will be collected and stored in a manner intended to preserve patient confidentiality. To preserve 
privacy, only approved study personnel will conduct study visits or access study records. All study 
visits will occur in private offices to preserve participants’ privacy. 
 
Certificate of Confidentiality 
To further protect subject’s privacy and confidentiality, the investigators will obtain a Certificate of 
Confidentiality from the National Institute of Health. With this Certificate, the investigators cannot be 
forced (for example by court subpoena) to disclose information that may identify subjects in any 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings. 
The informed consent document will include a statement that this study has a Certificate of 
Confidentiality and will describe the type of information that will be included in the subjects VHA 
medical record. 
 
VA-SPECIFIC REQUIREMENTS:  
N/A. The study does not include a Certificate of Confidentiality. 
 
Information and/or Specimen Management 
 
VA-SPECIFIC REQUIREMENTS:  
 
All study data derived from subject procedures will be obtained specifically for research purposes. 
Data will be stored in a manner intended to preserve patient confidentiality. Raw data (e.g., collected 
from neuropsychiatric assessment visit procedures) will be stored in locked cabinets and on 
password protected computers in limited access folders behind the VA firewall. Each subject is 
assigned a unique identifier (study ID) based on a study identifier and number (i.e., CCTA-xxx). Only 
coded or de-identified data, not PHI, are used for analysis. Coded data will also be stored on OHSU's 
REDCap application, a highly secure and robust web-based research data collection and 
management system. The file linking the unique identifier with the patient’s name will be stored in a 
separate password-protected file on a secure computer behind the VA firewall. Consent forms and 
the key linking names to identifiers will be stored in locked file cabinets or on password protected 
computers in limited access folders behind the VA firewall, and the key and consents will be stored 

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separately from the de-identified data files. Once the study has ended, the link will be stored by the 
VAPORHCS Research & Development Service. 
 
Disclosure/Sharing: 
 
VA-SPECIFIC REQUIREMENTS:   
N/A. The study does not include disclosure/sharing outside the IRB-approved VAPORHCS study 
personnel. 
  
 
Transfer of Data Ownership 
 
VA-SPECIFIC REQUIREMENTS:  
N/A. The study does not include transfer of data ownership. 
 
Web Application(s), Mobile Device(s) and/or Mobile Application(s): 
 
VA-SPECIFIC REQUIREMENTS: 
N/A. The study does not include web application(s), mobile device(s) and/or mobile application(s). 
 
A study team member will schedule study visits and CCT sessions with the Veteran and then send 
the Veteran a link for VVC through the Virtual Care Manager platform (no direct email contact 
between Veteran and study personnel will be initiated; all contact will be through the Virtual Care 
Manager or other VA-approved scheduling systems to ensure that no PHI is sent over email). VVC 
precautions for safety will be verified (i.e., veteran’s physical address at time of appointment in case 
of emergency). No recordings will take place during study visits or CCT sessions.  
 
VA REDCap will not be utilized for this study since VA REDCap is an intranet-only application that 
would require participants to have an active VA network account to be able to complete 
questionnaires within the application. Instead, OHSU’s REDCap server will be utilized to store 
questionnaire data. Veterans will have the choice of either completing questionnaires online (through 
OHSU REDCap) or on paper. If the Veteran chooses to complete the questionnaires online, a link to 
the online questionnaires will be sent in the mail in their appointment confirmation letter. If the 
Veteran chooses to complete the questionnaires on paper, the paper questionnaires will be sent in 
the same envelope as their appointment confirmation letter. Only coded data will be stored on 
OHSU's REDCap application, a highly secure and robust web-based research data collection and 
management system. The questionnaires will have an alphanumeric code that will be linked to the 
participants’ names in a separate spreadsheet that will remain behind the VA firewall at VAPORHCS. 
No identifiable information will be entered into REDCap at any time. 
 
Data and Safety Monitoring Plan (DSMP)  
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
VA-SPECIFIC REQUIREMENTS:  
 

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Monitoring human participant recruitment, neuropsychiatric data collection, and data entry will be 
performed by the Co-PIs and study staff. Any adverse events will be reported immediately to the Co-
PIs who will evaluate the patient and determine if any additional evaluation or treatment is needed. 
Ms. Shirley will ensure that adverse events are properly reported to the IRB. The study staff will 
examine all cumulative adverse events quarterly to determine if there are any systematic problems. 
The balance of risk to benefit will be continuously monitored by the Co-PIs, and the study may be 
modified or terminated if risks begin to outweigh benefit.  
 
Study staff is trained on the protocols to ensure that procedures are being conducted within the scope 
of the approved protocols. Maya O’Neil, PhD, (Co-PI), a licensed psychologist and neuropsychologist, 
supervises Ms. Shirley (Co-PI) and other clinical research staff in the administration and scoring of 
neuropsychological tests and psychological measures. Recruitment and enrollment will be reviewed 
monthly in meetings with Ms. Shirley and Dr. O’Neil. At these meetings, the research team will 
problem solve recruitment issues to ensure that projected enrollment numbers are obtained. Ms. 
Shirley will check procedures (at least monthly) to verify that they are being conducted per the 
approved protocol, including the responsibilities and roles for gathering and monitoring data. The data 
are recorded by research staff as it is collected, and data accuracy is verified by double scoring, data 
entry, and visual verification.  
 
Step-by-Step Guidance on Conducting the Study 
 See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
The study procedures and timeline are outlined in Figure 2 below. 
 
 
 
References & Literature Cited 
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
References 
 
American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders (5th ed.).  
Boden, M., & Hoggatt, K. (2018). Substance use disorders among Veterans in a nationally representative 
sample: Prevalence and associated functioning and treatment utilization. Journal of studies on alcohol 
and drugs, 79(6), 853-861. https://doi.org/https://doi-org.liboff.ohsu.edu/10.15288/jsad.2018.79.853  
Bruijnen, C., Dijkstra, B. A. G., Walvoort, S. J. W., Markus, W., VanDerNagel, J. E. L., Kessels, R. P. C., & 
CAJ, D. E. J. (2019). Prevalence of cognitive impairment in patients with substance use disorder. Drug 
Alcohol Rev, 38(4), 435-442. https://doi.org/10.1111/dar.12922  
Figure 2. Study Flow Chart and Activities 
 
 
 
 
 
 
 
Screening 
• 
Referral 
• 
Medical 
Records review 
• 
Phone 
Screening 
Baseline Visit 
• 
Informed 
Consent 
• 
Assessment 
Protocol 
ME-CCT-A (8 
Weeks) 
• 
Group 
Intervention 
 
Follow-up Visit (0-2 
weeks after ME-CCT-A 
group completion) 
• 
Assessment 
Protocol 

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Connolly, S. L., Stolzmann, K. L., Heyworth, L., Weaver, K. R., Bauer, M. S., & Miller, C. J. (2021). Rapid 
Increase in Telemental Health Within the Department of Veterans Affairs During the COVID-19 
Pandemic. Telemed J E Health, 27(4), 454-458. https://doi.org/10.1089/tmj.2020.0233  
Czapla, M., Simon, J. J., Richter, B., Kluge, M., Friederich, H. C., Herpertz, S., Mann, K., Herpertz, S. C., & 
Loeber, S. (2016). The impact of cognitive impairment and impulsivity on relapse of alcohol-dependent 
patients: implications for psychotherapeutic treatment. Addict Biol, 21(4), 873-884. 
https://doi.org/10.1111/adb.12229  
Elnitsky CA, A. E., Clark ME, McGarity S, Hall CG, Kerns RD. (2013). Access to the US Department of 
Veterans Affairs health system: selfreported barriers to care among returnees of Operations Enduring 
Freedom and Iraqi Freedom. BMC Health Serv Res, 13(1), 1-10.  
Fiacco, L., Pearson, B. L., & Jordan, R. (2021). Telemedicine works for treating substance use disorder: The 
STAR clinic experience during COVID-19. J Subst Abuse Treat, 125, 108312. 
https://doi.org/10.1016/j.jsat.2021.108312  
Frost, M. C., Matson, T. E., Richards, J. E., Lee, A. K., Achtmeyer, C. E., Bradley, K. A., & Williams, E. C. 
(2022). Barriers and facilitators to changing drinking and receiving alcohol-related care: Interviews with 
Veterans Health Administration primary care patients who indicated interest but did not enroll in an 
alcohol care management intervention trial. Subst Abus, 43(1), 1197-1206. 
https://doi.org/10.1080/08897077.2022.2074602  
Gentry, M. T., Lapid, M. I., Clark, M. M., & Rummans, T. A. (2019). Evidence for telehealth group-based 
treatment: A systematic review. J Telemed Telecare, 25(6), 327-342. 
https://doi.org/10.1177/1357633X18775855  
Glass, J. M., Buu, A., Adams, K. M., Nigg, J. T., Puttler, L. I., Jester, J. M., & Zucker, R. A. (2009). Effects of 
alcoholism severity and smoking on executive neurocognitive function. Addiction, 104(1), 38-48. 
https://doi.org/10.1111/j.1360-0443.2008.02415.x  
Gomez-Pinilla, F. (2006). The impact of diet and exercise on brain plasticity and disease. Nutr Health, 18, 277–
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From the National Epidemiologic Survey on Alcohol and Related Conditions III. JAMA Psychiatry, 
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K., Olavarria, H., Sasaki, A. W., Chang, M., Flora, K. D., & Loftis, J. M. (2015). A longitudinal study 
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chronic hepatitis C. J Psychosom Res, 78(2), 184-192. https://doi.org/10.1016/j.jpsychores.2014.07.020  
Huckans, M., Fuller, B. E., Chalker, A. L., Adams, M., & Loftis, J. M. (2015). Plasma Inflammatory Factors Are 
Associated with Anxiety, Depression, and Cognitive Problems in Adults with and without 
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Huckans, M., Hutson, L., Twamley, E., Jak, A., Kaye, J., & Storzbach, D. (2013). Efficacy of cognitive 
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CCT-A). Unpublished treatment manual.  

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Kintzle, S., Rivas, W. A., & Castro, C. A. (2022). Satisfaction of the Use of Telehealth and Access to Care for 
Veterans During the COVID-19 Pandemic. Telemed J E Health, 28(5), 706-711. 
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factors and pharmacological treatments. Exp Clin Psychopharmacol, 27(3), 203-214. 
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Appendix – Supporting Documents List 
See sponsor/3rd party protocol for requested information in this section. Indicate what 
heading/subheading in the 3rd party protocol that the information is located:       
 
 
 
 
 
 
 
 
 
Questionnaires and surveys 
Portland Cognitive Strategies Scale 2.0 (PCSS) 
Brief Addiction Monitor (BAM) 
Prospective-Retrospective Memory Questionnaire (PRMQ) 
PROMIS–57 Profile v2.1 
PROMIS v2.0 Cognitive Function 8a 
Client Satisfaction Questionnaire (CSQ-8) 
Timeline Followback (TLFB) 
Alcohol Use Disorders Identification Test (AUDIT-C) 
 
Neuropsychological assessments 
Wide Range Achievement Test, Fifth Edition (WRAT5™)  
Neuropsychological Assessment Battery (NAB) Attention Module subtests: Digit Span; Driving 
Scenes 
Neuropsychological Assessment Battery (NAB) Memory Module subtests: List Learning; Shape 
Learning; Medication Instructions; Name, Address, and Phone Number 
Neuropsychological Assessment Battery (NAB) Executive Function Module subtests: Judgment; 
Categories 
Delis-Kaplan Executive Function System (D-KEFS) subtest: Verbal Fluency 
 
Other documents 
Appointment confirmation letters (baseline and follow-up)  
No contact letter 
Clinical interview forms (baseline and follow-up)  
Screening form (prior to enrollment)  
PI recruitment letter