The Impact of CBT for Insomnia on Alcohol Treatment Outcomes Among Veterans
Phase: NA
Conditions: Insomnia, Alcohol Use Disorder
Sponsor: University of Missouri-Columbia

Date:    09/20/2021 
Version Number:        12       
Principal Investigator:    Mary Beth Miller, PhD 
 
Application Number:   2012262 
 
Application Title:   The Impact of CBT for Insomnia on Alcohol Treatment Outcomes among Veterans (Project 
SAVE) 
Protocol 
 
 
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1. Abstract 
Alcohol use disorders (AUDs) are prevalent among Veterans and result in significant physical and 
psychological burden. Among those who receive treatment for AUDs, 1 in 3 relapses to problematic drinking 
within one year of treatment. Thus, additional strategies are needed to enhance alcohol treatment outcomes. One 
promising approach involves providing concurrent treatment for a common complaint – difficulty falling or 
staying asleep. Up to 74% of Veterans seeking treatment for AUD report co-occurring symptoms of insomnia. 
Given the negative impact of insomnia on attention and emotion regulation, insomnia symptoms may decrease 
patients’ abilities to attend to alcohol treatment and manage negative emotions that lead to craving and relapse. 
Moreover, approximately 50% of individuals with AUDs report using alcohol to help them sleep, making 
relapse more likely for those with no other tools or skills to help them sleep. Indeed, sleep disturbance has been 
identified as a risk factor for relapse among individuals in alcohol treatment. Thus, effective treatment of sleep 
problems may enhance alcohol treatment. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been 
effective in reducing insomnia severity in individuals with AUDs; however, no investigations have examined 
the efficacy of CBT-I delivered concurrently with AUD treatment to determine its impact on treatment 
outcomes. This R21 aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to 
outpatient alcohol treatment. A randomized pilot trial with 80 Veterans who meet diagnostic criteria for AUD 
and Insomnia Disorder will be conducted. Participants will be randomly assigned to receive Cognitive 
Behavioral Therapy for Insomnia (CBT-I) or minimal treatment (sleep hygiene handout only; SH) in addition to 
alcohol treatment as usual. Outcomes will be assessed at the end of the active intervention period (6 weeks) and 
6 weeks post-intervention. Outcomes of interest include recruitment/retention rates, treatment satisfaction, 
insomnia severity, use of alcohol as a sleep aid, percentage of heavy-drinking days, and alcohol-related 
problems. Analyses will focus on size of treatment effects. This study will provide initial evidence that 
treatment of insomnia not only improves sleep but also allows participants to derive greater benefit from 
outpatient alcohol treatment. 
 
2. Objectives (include all primary and secondary objectives) 
(1) To test the feasibility and acceptability of a CBT-I supplement to outpatient alcohol treatment. 
(2) To evaluate the initial efficacy of the CBT-I supplement on alcohol use outcomes. 
 
3. Background 
Up to 74% of Veterans seeking treatment for alcohol use disorder (AUD) report symptoms of insomnia.1,2 
These symptoms represent a barrier to alcohol treatment for three distinct reasons. First (1), approximately 
50% of individuals with alcohol use disorders report using alcohol to help them sleep;3-5 thus, those without 
alternative sleep aids may relapse to drinking if insomnia persists. Insomnia symptoms have also been 
associated with significant deficits in (2) attention/working memory6,7 and (3) emotion regulation.8-11 Because 
cognitive-behavioral alcohol therapies (CBT) capitalize on individuals’ use of these abilities to identify and 
adapt to the stimuli that lead to alcohol use, CBT-based treatments may have limited effectiveness for patients 

with insomnia. This combination of factors – continued insomnia and limited cognitive/emotional capacity to 
respond to treatment – may explain in part why insomnia symptoms precipitate relapse12 among the 1 in 3 
individuals who relapse to problematic drinking within one year of alcohol treatment.13,14 
 
Cognitive Behavioral Therapy (CBT-I) is the first line of treatment for insomnia. It has been associated with 
moderate to large improvements in insomnia outcomes, with effects maintained 24 months after treatment.15 It 
has been effective in reducing insomnia severity and sleep complaints among U.S. military Veterans, including 
those with comorbid PTSD and depression.16-18 It has also been effective in reducing symptoms of insomnia – 
but not subsequent rates of relapse – among alcohol dependent individuals with 1+ months of sobriety.19-21 
However, no research has examined the impact of CBT-I among individuals actively engaged in alcohol 
treatment. Improving sleep is expected to enhance the efficacy of alcohol treatment among Veterans by 
enhancing their abilities to attend to treatment, regulate their emotions, and initiate sleep without alcohol. 
 
Consistent with PA-18-202, the proposed R21 aims to examine the feasibility, acceptability, and initial efficacy 
of a CBT-I supplement to outpatient alcohol treatment. The primary objective of this study is to enhance 
alcohol treatment to account for the unique needs of Veterans with sleep disorders. We propose a 6-week 
randomized trial, in which 80 Veterans will be randomly assigned to receive Cognitive Behavioral Therapy for 
Insomnia (CBT-I) or minimal treatment (sleep hygiene only; SH) in addition to treatment as usual. Individuals 
participating in the Addictions Treatment Program at the Truman VA will be eligible to participate if they meet 
DSM-5 criteria for AUD and the episodic criterion (≥1mo) for Insomnia Disorder. Participants will complete 
assessments at baseline, post-treatment, and 6-week follow-up. We propose the following specific aims: 
 
Aim 1:  To test the feasibility and acceptability of CBT-I delivered concurrently with alcohol 
treatment. Recruitment (anticipated enrollment of at least 2 Veterans per month) and retention rates (goal 
≥70% complete 6/6 treatment sessions) will indicate feasibility of the intervention. Treatment satisfaction 
(average score ≥ 3, indicating ‘mostly satisfied’) will serve as an indicator of acceptability. Retention and 
satisfaction will be measured separately for insomnia and alcohol treatments. 
 
Aim 2:  To evaluate the initial efficacy of CBT-I on insomnia and alcohol use outcomes. We 
hypothesize that Veterans receiving CBT-I will demonstrate greater improvements in insomnia severity, 
sleep efficiency, use of alcohol as a sleep aid, percentage of heavy-drinking days, and alcohol-related 
problems post-treatment and at 6-week follow-up.  
 
Aim 3 (exploratory):  To examine proximal intervention outcomes. We hypothesize that Veterans 
receiving CBT-I will demonstrate greater post-treatment improvements in attention (vigilance), working 
memory, treatment-related learning, negative affect, and emotion regulation.  
 
4. Study Procedures 
This study will examine the feasibility, acceptability, and initial efficacy of Cognitive Behavioral Therapy for 
Insomnia (CBT-I) delivered concurrently with CBT for AUD using a randomized, parallel, two-group design 
(see Figure 1). Eighty Veterans will be randomly assigned to either CBT-I or a sleep hygiene education control 
(SH). All outcomes will be assessed at baseline, post-treatment, and 6-week follow-up. This design will allow 
us to test the feasibility and acceptability of CBT-I among those in treatment for AUD (Aim 1); evaluate the 
initial efficacy of CBT-I in improving insomnia and alcohol-related outcomes (Aim 2); and examine CBT-I 
effects on attention, working memory, learning, negative affect, and emotion regulation, which may be 
examined as mediators in a subsequent trial (Aim 3).  
 
Study site. Participants will be recruited through the Addictions Treatment Program at the Harry S. Truman 
Memorial Veterans Hospital (Truman VA) in Columbia, MO. We will recruit 115 participants over 20 months 
(see Table 2) to obtain a final sample of at least 80 participants.  
 

Participants. Patients in the Addictions Treatment Program at the 
Truman VA will be included if they meet DSM-5 criteria for 
Alcohol Use Disorder and the episodic criterion (≥1mo) for 
Insomnia Disorder. Criteria for AUD include 2+ symptoms in the 
past 12 months that result in distress or impairment related to 
alcohol use (e.g., using more than intended, unsuccessful attempts 
to cut down). Criteria for insomnia include difficulty (>30min) 
falling asleep, staying asleep, or waking up too early on 3+ nights 
per week despite adequate opportunity and circumstances for sleep; 
and daytime impairment in mood, cognitive, social, or occupational 
activities.22 Participants will be excluded if they are unable to 
provide informed consent, demonstrate cognitive impairment, 
report continuous sobriety for more than 2 months at baseline 
assessment, report a manic episode or seizure (contraindications for 
sleep restriction)23 in the past year, have a severe psychiatric 
disorder that requires immediate clinical attention (e.g., psychosis, 
suicidal ideation with intent and plan), or began a new sleep medication in the past 6 weeks. Consistent with 
standard practice, those who endorse symptoms of sleep-related breathing disorders (≥2/8 symptoms on the 
STOP-BANG24), restless leg syndrome, periodic limb movement disorder, or narcolepsy will be referred for 
overnight polysomnography.  
 
Recruitment and initial screening. Patients in the Addictions Treatment Program (ATP) at the Truman VA will 
be recruited via flyers and provider referral. All residential patients at the ATP will receive a flyer about the 
study and complete a brief (9-item) screener for the study as part of the intake process. Providers will share the 
de-identified results of the screener with PI Miller. If participants are interested in the study, they may contact 
the research team directly. However, to decrease burden on both providers and participants, providers will also 
have the option of providing the research team with contact information for patients who may be eligible and 
interested. The research team will then reach out to the patient directly to assess their interest in participating. 
Research staff will reach out to potential participants three times by phone. Research staff will also attend the 
beginning of treatment groups/meetings in order to inform individuals about the study and answer any questions 
they may have. PI Miller will participate in weekly behavioral health team meetings to facilitate the screening 
and recruitment process (i.e., reminding them about the study, updating them on recruitment progress, and 
answering any questions). 
Phone screening. A research assistant (RA) will share more details about the study and conduct a brief 
eligibility screen (~15min) with the potential participant in person or over the phone (see Table 1). Those who 
screen eligible will be scheduled for baseline. 
 
Baseline assessment. Participants will provide written informed consent prior to completion of baseline (see 
Table 1). In the case of remote baseline assessments, an RA will walk the participant through an electronic 
version of the written consent form, which they will be asked to sign electronically via the Qualtrics platform. 
The RA will then print and sign the electronic version of the participant’s consent.  The baseline evaluation will 
involve assessment of substance use and sleep disorders and full eligibility criteria using the Mini International 
Neuropsychiatric Interview (MINI) 7.0.2. Consistent with standard practice, those who endorse symptoms of 
sleep-related breathing disorders, restless legs syndrome, periodic limb movement disorder, or narcolepsy will 
be referred for polysomnography. Given the prevalence of sleep apnea in this population, individuals who meet 
all eligibility criteria but report symptoms of sleep apnea will complete one night of holter monitoring (using an 
Evo Holter Recorder, SpaceLabs Healthcare) at home in their own beds to rule out for sleep apnea.  
 
Eligible participants will complete baseline assessment measures and will be randomly assigned to either the 
CBT-I or SH condition. Participants in both conditions will be oriented to the prospective sleep diary, which 

they will be asked to complete every morning for the next 6 weeks. The RA will provide all participants with a 
general handout on sleep hygiene (from the National Sleep Foundation website) and answer any questions they 
may have about the guidelines. 
 
To confirm diagnosis of insomnia, all eligible participants will complete one week of daily sleep diaries 
(between baseline and treatment session 1), which will be collected electronically and time-stamped each 
morning using the Qualtrics data management system. Participants who have not completed the diary each 
morning by noon will receive a reminder text or phone call from study staff. Sleep diaries measure sleep onset 
latency, wake after sleep onset, total sleep time, sleep efficiency, and sleep quality. In this study, sleep diaries 
will also assess use of sleep medication and use of alcohol/other drugs (yes/no) to help with sleep. Sleep 
medication variables will include name, dosage, and time taken and will be converted to lowest recommended 
dosage units for data analysis.25 Participants who are unable to complete the daily sleep diaries by computer or 
phone will be provided with pen-and-paper surveys to fill out 
each day by hand. 
 
Follow-up. Follow-up assessments (see Table 1) will be 
administered in person by the RA, who will be blind to 
participant condition. Upon completion of the study, SH 
participants will be offered a referral for CBT-I, which is 
available with trained providers at the VA. 
 
Remote appointments. If needed, treatment and follow-up 
appointments may be completed remotely using Zoom Pro or 
the VA’s Video Connect service. Using their VA email from the 
VA laptops, research staff would send the participant a link to 
launch the session. Participants wanting to use their iPhone or 
iPad for the session would have to download the VA Video 
Connect application onto their device. On all other devices (e.g., 
PCs, laptops, Android devices), the participant will simply open 
the email and click the link to launch the secure video session. 
This service uses encryption to ensure that sessions are private 
and secure and is designed for Veterans in rural areas with 
limited access to healthcare facilities. 
 
Retention strategies. To enhance follow-up rates, participants 
will receive: 
− Up to $40 for baseline (~2hr):  $10 for completing the assessment, $10 for completing all seven daily 
surveys, and $20 for returning the actiwatch.    
− Up to $50 for the post-treatment assessment (~1hr):  $40 for completing the assessment and $10 for 
completing all seven daily surveys 
− Up to $60 for the 6-week follow-up (~1hr):  $50 for completing the assessment and $10 for completing 
all seven daily surveys 
Participants will also receive reminder texts/calls, have access to free parking, and receive treatment at no cost. 
 
Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I will be delivered individually, in person, in five 
weekly one-hour sessions. A sixth week of treatment will be included – and scheduled for the same date as the 
post-treatment assessment – if the participant and research team agree that it would be beneficial (e.g., if a 
participant has difficulty grasping cognitive therapy concepts). Study therapists will follow the 2014 CBT-I in 
Veterans manual developed by leading researchers in the behavioral sleep medicine field (see Table 3).23 
Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and 
rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep 
Table 1. Assessment, therapy, and payment 
schedule 
Week 
Assmt 
CBT-I 
Paymt Bonus 
1 
BL 
 
10 
 
2 
 
S1 
20 
10 
3 
 
S2 
 
 
4 
 
S3 
 
 
5 
 
S4 
 
 
6 
 
S5 
 
 
7 
Post-tx 
(S6) 
40 
 
8 
 
 
 
10 
9 
 
 
 
 
10 
 
 
 
 
11 
 
 
 
 
12 
1mo 
 
50 
 
13 
 
 
 
10 
Note. 1mo = 1 month. Assmt = 
assessment. BL = baseline. Bonus = bonus 
payment for completion of all 7 daily 
surveys. Paymt = standard payment.  
Tx = treatment. 

environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of 
time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) 
stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) 
relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and 
(5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.  
 
Sleep hygiene (SH). All participants will receive a one-page handout on sleep hygiene. This is the only 
intervention that participants assigned to the SH condition will receive and is consistent with what may be 
expected as standard care in a doctor’s visit with a primary care physician.  
 
Table 2. Survey Instruments and Schedule of Administration 
Use 
Construct 
Measure(s) 
Cut-score 
Screen 
Insomnia severity, past 2 weeks 
Insomnia Severity Index  
(Morin et al., 2011) 
≤ 9 excluded at 
phone screen 
 
Sleep apnea, past month 
STOP questionnaire  
(Chung et al., 2008) 
≥ 3 excluded at 
phone screen 
Use 
Construct 
Measure(s) 
BL 
Post 
6wk 
Cov 
Demographics 
See instruments 
X 
 
 
 
Other drug use, past 6 weeks 
Drug Use Screening Inventory 
X 
X 
X 
 
Use of sleep medication 
Daily Sleep Diary (Carney et al., 2012) 
X 
X 
X 
Aim 1 
Recruitment 
Completion of ≥ 1 session of CBT-I 
 
X 
 
 
Retention 
Completion of 6/6 sessions of CBT-I 
 
X 
 
 
Treatment satisfaction, measured 
separately for CBT-I and CBT-AUD 
Client Satisfaction Questionnaire  
(Larsen et al., 1979) 
 
X 
 
Aim 2 
% abstinent days, past 6 weeks 
% heavy-drinking days (≥4/5 
drinks/day for women/men)  
Timeline Follow-back (TLFB) for alcohol  
(Sobell & Sobell, 1996) 
X 
X 
X 
 
Alcohol problems, past 6 weeks 
Short Inventory of Problems (Miller et al., 1995) 
X 
X 
X 
 
Use of alcohol or other drugs to 
help with sleep, past 6 weeks 
Daily Sleep Diary (Carney et al., 2012) 
X 
X 
X 
 
Insomnia severity, past 2 weeks 
Insomnia Severity Index (Morin et al., 2011) 
X 
X 
X 
 
Total wake time, average past week 
Daily Sleep Diary (Carney et al., 2012) 
X 
X 
X 
 
Sleep quality, average past week 
Daily Sleep Diary (Carney et al., 2012) 
X 
X 
X 
 
Dysfunctional beliefs, past month 
Dysfunctional Beliefs about Sleep Scale 
X 
X 
X 
Aim 3 
Treatment-related learning 
Project SAVE Alcohol Quiz 
Project SAVE Alcohol Vignette  
X 
X 
X 
 
Executive functioning 
Psychomotor Vigilance Task  
(Dinges et al., 1985) 
N-back Task (Schmiedek et al., 2014) 
Monetary Choice Questionnaire 
UPPS Measure of Impulsivity 
Cognitive Failures Questionnaire 
X 
X 
X 
 
Negative affect, past week 
Positive and Negative Affect Schedule 
X 
X 
X 
 
Emotion regulation, past 30 days 
Brief Difficulties in Emotion Regulation Scale  
(Bjureberg et al., 2016) 
X 
X 
X 
 
Alcohol craving, past week 
Penn Alcohol Craving Scale 
X 
X 
X 
 
Mental health symptoms 
PTSD Checklist for DSM-5 
Patient Health Questionnaire-9 for depression 
GAD-7 measure of anxiety 
Satisfaction with Life Scale 
X 
X 
X 
Note. BL=baseline. Cov = potential covariates. Post = post treatment. Wk = week. 
 
Blinding. PI Miller will not be blinded to block size or participant assignment because she will inform study 
therapists of participant assignment to conditions. However, PI Miller and study therapists will be blinded to 
assessment outcomes, and the assessment RA will be blinded to participant condition.  
 

Treatment integrity. Treatment integrity will be assured in three steps. (1) Delivery. The study therapist will 
receive training in use of the treatment manual via audio-recorded mock therapy sessions. PI Miller and co-I 
McCrae, both of whom are licensed clinical psychologists, will evaluate audiotapes of mock sessions and 
provide corrective feedback. All intervention sessions will be audio-recorded, given participant permission. PI 
Miller and co-I McCrae will review session audiotapes for ongoing training and supervision. PI Miller will 
score five randomly selected tapes to assess treatment fidelity using a checklist of treatment elements. 
Descriptive analyses will be used to determine the proportion of intended treatment elements covered in 
intervention sessions. (2) Comprehension. Participants will be provided with a workbook detailing treatment 
instructions, rationale, and handouts and encouraged to ask questions. (3) Enactment. Workbooks will contain 
written instructions on home assignments, and therapists will encourage assignment completion.  
 
Early termination. All participants will receive sleep hygiene recommendations immediately following baseline 
assessment, so every participant who attends baseline will receive some form of treatment for insomnia. 
However, participants may decide to stop participating in the study at any time without penalty. If they decide 
to withdraw their participation, therapy will be terminated. This will be discussed as part of the informed 
consent process.  
 
5. Inclusion/Exclusion Criteria 
Eligibility criteria include (a) participation in the Addictions Treatment Program at the Truman VA, (b) DSM-5 
criteria for moderate to severe Alcohol Use Disorder, (c) alcohol use in the past 2 months at baseline, and  
(d) the DSM-5 episodic criterion (duration at least 1 month) for Insomnia Disorder.  
 
Participants will be excluded if they are unable to provide informed consent, demonstrate cognitive impairment 
(Mini Mental Status Exam score <26), report a manic episode or seizure in the past year (contraindications for 
CBT-I),23 have a severe psychiatric disorder that requires immediate clinical attention (e.g., psychosis, suicidal 
ideation with intent and plan), or began a sleep medication in the past 6 weeks. Consistent with standard 
practice, those who endorse symptoms of sleep-related breathing disorders (≥2/8 symptoms on the STOP-
BANG24), restless leg syndrome, periodic limb movement disorder, or narcolepsy will be referred for 
polysomnography. 
 
6. Drugs/ Substances/Devices 
N/A 
 
7. Study Statistics 
 
Outcome measures. Outcome measures are listed in Table 1 above. Primary outcomes include recruitment, 
retention, and  treatment satisfaction (Aim 1) as well as insomnia severity, total wake time, sleep quality, 
percent days abstinent, percent heavy-drinking days, alcohol problems, and use of alcohol or other drugs as a 
sleep aid (Aim 2). Secondary (Aim 3) outcomes include treatment-related learning, executive function 
(attention, working memory, delayed discounting, impulsivity), negative affect, emotion regulation, craving, 
and mental health symptoms (PTSD, depression, anxiety, life satisfaction). 
 
Aim 1 analyses. Recruitment (goal ≥4pts/mo) and retention rates (≥70% complete 5/5 sessions) will indicate 
feasibility of the intervention. Treatment satisfaction (average score ≥3, indicating ‘good’ quality) will serve as 
an indicator of acceptability. Recruitment, retention, and satisfaction will be measured separately for insomnia 
and alcohol treatments. We do not expect group differences in recruitment. Descriptive statistics, chi-square, 
and t-tests will be used to determine between-group differences in retention and satisfaction. 
 
Aims 2-3 analyses.  Cohen’s d (adjusted for baseline scores) and 95% CIs will be used to examine the 
magnitude of between-group differences at post-treatment and 6-week follow-up. We will use HLM to compare 
conditions at post-treatment and 6 weeks. We chose HLM over other statistical approaches (e.g., ANOVA) 
because it requires fewer assumptions, has superior ability to handle missing data, and will yield greater 

statistical power. In each model, the Level 1 variable will be time. Level 2 portions of the model will include 
the effect of condition. Hypotheses will be tested by regressing condition on the Level 1 intercept and time 
effect. Analyses will be intent-to-treat. We will examine whether attrition is associated with any baseline 
variables and control for such variables when necessary. 
 
Power analysis. Post-hoc power analyses conducted in G*Power 3.0.10 indicate that 80 participants will 
provide strong power (1 – β = .99) to detect within-between interactions of moderate magnitude (f = .25). 
 
Early stopping rules. PI Miller will monitor adherence to the study protocol and adverse events on an ongoing 
basis and discuss these issues with the research team during weekly meetings. All serious and unexpected 
adverse events will be reported to the IRB within 24 hours of receipt of information. Other adverse or 
potentially adverse events will be monitored and reported at annual continuing reviews. After discussion with 
the IRB, we will discontinue the trial if there is (a) compelling evidence from this or another study of a serious 
adverse effect of CBT-I that has potential to override potential benefit, (b) compelling evidence from this or 
another study of a significant beneficial effect of CBT-I, such that continued denial to other groups would be 
unethical, or (c) low probability of addressing study aims within a feasible time frame.  
 
8. Risks 
We believe the risks associated with completing assessments and participating in the intervention are minimal. 
Potential risks include: temporary daytime fatigue (due to restriction of time in bed), subjective discomfort from 
answering questionnaires, coercion, and the possibility of a breach of confidentiality. Because the sleep 
restriction component of CBT-I places individuals with a history of mania at risk for additional manic episodes, 
the treatment will be modified for these individuals. Participants will not incur financial risk. There are no other 
known iatrogenic effects of CBT-I or completion of sleep diaries. However, if any emerge, they will be 
addressed immediately by research and/or clinical staff. 
 
The following safeguards will be implemented to protect participants from risks related to study participation:  
Temporary fatigue. Participants will be informed as part of the consent process that restricting their time 
in bed may increase daytime fatigue for the first few weeks of treatment (although this will be temporary, as 
time in bed will be expanded as sleep efficiency improves). Consistent with standard insomnia treatment 
procedures, time in bed will never be restricted to less than 5 hours in order to avoid impaired vigilance and 
significant daytime sleepiness. Participants will also be provided with recommendations on ways to increase 
alertness and counter daytime fatigue (e.g., staying active, engaging in social activities).  
Discomfort. Participants will be informed of the types of questions that they will be asked to answer as 
part of the informed consent process, and they will have the opportunity to skip questionnaire items or 
discontinue participation in the study at any time without penalty. Referrals will be provided to participants 
during the consent and throughout the study, in the event that participants report experiencing distress. 
Coercion. Participants will be provided with modest compensation for their participation in the study 
(up to $150 for 3 assessments and 3 complete weeks of daily sleep surveys). We believe these compensation 
rates are commensurate with the time and effort involved in these tasks, and the amounts are consistent with 
compensation provided for other clinical studies with Veterans. Participants are free to discontinue at any time 
and will receive compensation for any and all assessments that they complete.  
Confidentiality. Study data will be handled only by research staff and will be used strictly for research 
purposes. All research staff will be trained in responsible research conduct and the handling of private and 
confidential information. Identifying information will not be recorded in computerized or paper-and-pencil 
assessments; rather, assessment instruments and related study data will be identified and tracked using a unique 
study identification number. The database containing identification numbers and contact information will be 
stored separately from study data and will be used to link baseline, post-treatment, and 6-week follow-up 
assessments. This database will be stored on a password-protected computer accessible only to research staff 
and will be destroyed immediately upon completion of the study. Study computers will also be stored in a 
locked office accessible only to research staff (PI Miller’s laboratory space in the Department of Psychiatry). 
Identifying information (names and dates) will appear only on consent forms, payment receipts, and the contact 

information form. All paper forms containing identifying information will be kept in a locked filing cabinet in 
Toni Maraldo’s office (C201E) at the VA, separate from any data; and only research staff will have access to 
these filing cabinets. Audiotaped sessions, which will be used in fidelity coding, will not be labeled with 
identifying information and will be deleted permanently once fidelity coding is complete. Data collected using 
computer software will be stored electronically and identified by unique study number only. No personally 
identifying information will be included in the data. A password will be required to access data that are stored 
electronically, and only personnel involved with the project will have access to the electronic data. The 
computer-administered surveys provide an additional layer of confidentiality protection relative to paper and 
pencil surveys where staff would see a participant’s data as they were entering or storing it.  
Participants will be informed verbally and in writing during the consent process that mandatory 
reporting laws will be followed. Subjects who indicate danger to themselves or others will be escorted to the 
emergency room.  
Given the sensitive nature of information being collected, all data will be protected by a Certificate of 
Confidentiality and identified using unique ID numbers assigned to participants specifically for this project. 
Names and identifying information required for follow-up reminders will always be kept separate from research 
data and will not be used as study data. Computerized survey data will be stored electronically on the secure VA 
server. Digital audio recordings of sessions, which will be used to determine treatment fidelity, will be stored on 
password-protected computers to which only project staff will have access. All research staff will be trained in 
procedures for maintaining data and participant confidentiality. Study personnel will no longer have access to 
the study data when they are no longer part of the research team. Data will not be removed from the VA. 
Protocol modifications for individuals with a history of mania or bipolar disorder. Because the sleep 
restriction component of CBT-I places individuals with a history of mania at risk for additional manic episodes, 
the treatment will be modified for these individuals (see Section 4 above) and individuals with a recent (past 
year) history of mania will be excluded. 
 
Data safety and monitoring plan. PI Miller will monitor procedures to ensure that they conform to the approved 
protocol. Specifically, she will monitor (a) the progress of the research, including participant recruitment and 
retention and assessments of data quality; (b) adverse events and procedures for making determinations that 
there may be a change to the benefit-to-risk ratio of research participation; and (c) procedures to protect 
participant privacy and confidentiality. She will monitor all serious, unexpected, and other adverse or 
potentially adverse events. Serious adverse events include those resulting in death, inpatient hospitalization, a 
threat to life, persistent or significant disability or incapacity, congenital anomalies/birth defects, or serious 
health risk. Unexpected adverse events are those that were unforeseen based on the anticipated potential risks 
outlined in the study protocol and informed consent. Other adverse or potentially adverse events include those 
that may be causally related to study participation and lead to participant distress or drop-out.  
 
PI Miller will monitor data quality and adverse events on an ongoing basis. All serious and unexpected adverse 
events will be reported to the IRB within 24 hours of receipt of information. Other adverse or potentially 
adverse events will be monitored and reported at annual continuing reviews. 
 
9. Benefits 
Participants in the CBT-I and SH conditions may benefit from the sleep-related information provided. 
Participants may also appreciate the opportunity to engage in research that may help others benefit from 
treatment. Beyond these potential benefits to subjects, this research is expected to inform future research and 
clinical efforts to treat insomnia and reduce the consequences associated with alcohol use among Veterans. As 
noted above, we believe the risks of this research to participants are minimal and the overall benefits of this 
research to subjects and society outweigh these risks. 
 
10. Payment and Remuneration 
To enhance follow-up rates, participants will receive up to $40 for completion of the baseline assessment ($10 
for the in-person assessment, $10 for completing all seven daily surveys, and $20 for returning the actiwatch), 
up to $50 for the post-treatment assessment ($40 for assessment, $10 for all daily surveys), and up to $60 for the 

6-week follow-up ($50 for assessment, $10 for all daily surveys), with the potential to earn up to $150. 
Participants will also receive reminder texts/calls, have access to free parking, and receive treatment at no cost. 
Participants who choose not to complete an assessment will not receive payment for that assessment; however, 
they will be invited to participate in any subsequent assessments (e.g., if they decline the post-treatment 
assessment, they will still be invited to complete follow-up).  
 
11. Costs 
Participants will be expected to travel to the VA for assessment and therapy appointments. It is unlikely that the 
expense of this travel will be a burden to participants, as the VA is easily accessible by foot, car, and public 
transportation. However, participants will be expected to cover the cost of these expenses. Participants will not 
be charged for other study procedures or for treatment.  
 
12. Data Use 
PI Miller will use all project data to oversee project management, treatment, and data analysis. Co-I McCrae 
will access audio data to provide clinical supervision (i.e., feedback on treatment integrity). Co-I Maddoux will 
access outcome data for data analysis. 
 
13. Software 
The computer program Inquisit will be required for assessments of executive functioning. Funds for Inquisit 
were included in the NIH application budget; thus, the PI will provide funds for this software. Participants’ 
performance on executive functioning tasks will be saved on the computer’s hard drive. However, these data 
will be tracked using unique participant identification numbers, rather than identifying information. All data 
will be transferred to the VA secure server as soon as possible. 
 
SPSS will be required for data analysis. The PI was informed that SPSS is available through VINCI. 
 
All software will be approved through the One VA Technical Reference Model for installation and use on the 
VA network.  
 
14. Web applications 
All eligible participants will also complete sleep diaries, which will be collected electronically and time-
stamped each morning using the Qualtrics data management system. As a company, Qualtrics is familiar with 
the nature of academic research and the importance of confidentiality, and their data handling procedures meet 
strict privacy standards (https://www.qualtrics.com/privacy-statement/). All data will be identified using unique 
participant IDs. The Qualtrics data centers utilize many security measures. Qualtrics’ database access is 
restricted and requires authorization. All computer equipment (servers, SANs, switches, routers, etc.) is 
redundant and is located in secure, environmentally controlled data centers with 24/7 monitoring. Web traffic 
does not directly access the database and database requests are reversed proxy via an application server to the 
database. All information is secured via industry standard firewalls and stringent IT security policies and 
procedures. Qualtrics utilizes industry standard web application firewalls and DDOS protection. Qualtrics also 
leverages panel partners who are meticulous in their multiple levels of security, which include redundant data 
centers, secure servers, encryption which includes one-way encryption, numeric IDs, secure .NET platforms, 
security clearance, industry standard firewalls, 24/7 monitoring of data centers, confidentiality agreements, and 
physical, electronic, and managerial procedures. While Qualtrics typically tracks IP addresses as part of its 
protocol, our research project will opt out of IP address tracking to ensure the survey responses remain 
confidential. Once downloaded, the data will be stored securely on the VA's network server. 
 
The VA’s Video Connect service will be used for remote appointments, if necessary. This service uses 
encryption to ensure that sessions are private and secure and is designed for Veterans in rural areas with limited 
access to healthcare facilities. Additionally, Zoom Pro will be an alternate videoconferencing resource for 
remote appointments. This service has end-to-end encryption and password-protected meetings. Data from these 
sessions will not be recorded or downloaded 

 
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