Provider Supported Self-Help Cognitive Behavioral Therapy for Insomnia (Tele-Self-CBTI)
Phase: NA
Conditions: Insomnia Disorder
Sponsor: VA Office of Research and Development

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Provider Supported Self-Help Cognitive Behavioral Therapy for Insomnia (Tele-Self 
CBTI) 
NCT03727438  
Protocol and Statistical Analysis plan 
Contingent approval 10/13/22, full approval 11/10/22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL TITLE: Tele-Self CBTI Trial 
 
PRINCIPAL INVESTIGATOR:  Christi S. Ulmer, PhD  
 
VERSION NUMBER AND DATE: Version 12, 09/1/2022 
 
SPONSOR/FUNDING SOURCE: VA HSR&D 
 
A. Purpose 
 
 
The proposed study is a randomized controlled trial comparing Tele-Self CBTI to Health 
Education Control for improved insomnia severity among treatment-seeking Veterans with 
Insomnia. In this 2-arm trial, 200 participants will be randomized in a 1:1 ratio to Tele-Self CBTI 
or a Health Education Control condition. Veterans will be identified using electronic health 
records and telephone interviews. Outcomes will be assessed at 3 time points: baseline, 8 
weeks, and 6 months after baseline. Participants in both arms will continue to receive usual 
medical care. Each assessment period involves a) 2 weeks of home-based sleep assessment 
(diary and actigraphy), and b) completion of telephone interview. Following completion of a 
home-based sleep assessment period, a questionnaire-based assessment will be conducted by 
phone.  
B. Background and Significance 
Insomnia is one of the most common complaints among service-members and Veterans 
of recent military conflicts. When Veterans of the Iraq and Afghanistan conflicts were asked 
what services they would be most likely to use if offered by the VA, “help with sleep” was 
endorsed more frequently than any other service1. Accordingly, insomnia diagnoses increased 
19-fold among military service members from 2000 to 20092. Insomnia has been shown to play 
a causal role in depression, anxiety, suicidality, disability due to a mental health disorder, 
hypertension, obesity, metabolic syndrome, diabetes, and all-cause mortality3-8. Thus, insomnia 
is a risk factor for the most common conditions seen in patients utilizing the VA healthcare 
system. 
Cognitive-Behavioral Therapy for Insomnia (CBTI) produces both short-term and 
sustained resolution of insomnia with fewer adverse side effects than pharmacotherapy9,10, and 
CBTI can be effectively delivered using a range of treatment modalities11,12. But access to 
behavioral sleep medicine expertise within the VA is very limited13, and recent efforts to 
disseminate CBTI across the VA will have only limited reach. Innovation is essential to 
simultaneously increasing Veteran access to CBTI while minimizing increased provider 
resources. Self-management and telehealth are viable options for achieving these goals. Our 
team has conducted qualitative research with Veterans to derive their attitudes and preferences 
for self-management of insomnia. Our findings suggest that Veterans would engage with 
provider-supported self-management strategies for insomnia, including CBTI via e-Health and 
telehealth approaches.  
Considering the high prevalence of sleep difficulties among Veterans (>50%), the mental 
health risks of poor sleep (e.g., anxiety, depression, and suicide), and Veterans’ desire for 
assistance with sleep, addressing Veterans’ sleep difficulties should be a central goal of VA 
efforts to achieve Veteran-centered care. The objectives of the proposed research are aligned 
with the following HSR&D High Priority Research domains: Healthcare Access-using telehealth 
to increase rural Veteran access to care; and Mental and Behavioral Health-testing new models 
of care to improve access, cost and outcomes. Since CBTI has demonstrated efficacy for 

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reducing suicidal ideation in Veterans, the proposed research is also responsive to an ORD-
wide priority area: suicide prevention. Treatment of insomnia in Veterans has the potential to 
improve outcomes across virtually all life domains, including mental health, physical health, 
psychosocial functioning, and quality of life. A provider-supported self-management strategy for 
insomnia can bridge the gap between unavailable resources and high demand for services.  
 
Aim 1: To test the effect of Tele-Self CBTI on insomnia severity in Veterans with insomnia. 
Hypothesis 1: Relative to Health Education, participants randomized to Tele-Self CBTI 
will have greater improvements in insomnia severity, as measured by the Insomnia 
Severity Index (ISI) at 8 weeks. 
Aim 2: To test the effect of Tele-Self CBTI on subjective and objectively assessed sleep, fatigue, 
depression symptoms, and sleep quality of life (QOL). 
Hypothesis 2: Relative to Health Education, participants randomized to receive Tele-Self CBTI 
will have greater improvements in subjective sleep (per diary on sleep onset latency (SOL), 
wake after sleep onset (WASO), sleep efficiency (SE), and objective sleep (per actigraphy 
WASO, total sleep time (TST), and SE), fatigue, depression symptoms, and sleep QOL at 8 
weeks. Aim 3: To inform future efforts, we will use qualitative research methods to examine 
nurse and clinic administrator perspectives on implementing and disseminating Tele-Self CBTI. 
 
 
Figure 1 
 
C. Randomized Controlled Trial (Aims 1 and 2) 
C.1 Study Design 
The proposed study is a randomized controlled trial comparing Tele-Self CBTI to Health 
Education Control for improved insomnia severity among treatment-seeking Veterans with 
Insomnia (Figure 1). In this 2-arm trial, 200 participants will be randomized in a 1:1 ratio to Tele-
Self CBTI or a Health Education Control condition. Veterans who are: a) prescribed sleep 
medications; b) diagnosed with insomnia; or c) referred for clinic based CBTI (but not yet 
treated) will be identified using electronic health records (EHR) and telephone interviews. 
Outcomes will be assessed at 3 time points: baseline, 8 weeks, and 6 months after baseline. 
These time points were selected to assess the immediate (8 weeks) effects of Tele-Self CBTI, 
and to determine if Tele-Self CBTI results in sustained improvements (6 months). Participants in 
both arms will continue to receive usual medical care. Each assessment period involves a) 2 
weeks of home-based sleep assessment (diary and actigraphy), and b) completion of self-report 

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questionnaires. Following completion of a home-based sleep assessment period, a 
questionnaire-based assessment will be conducted by phone by a research assistant blinded to 
treatment condition. Study participants will be asked to return actigraphy devices (as well as any 
paper forms) at the end of each assessment period via prelabeled UPS envelopes dropped off 
at a UPS location.   
 
C.2 Study Population 
The target population for this trial is treatment-seeking Veterans with Insomnia from the 
Durham Veteran’s Affairs Healthcare System. Because few VA PCPs routinely document 
insomnia in the medical record79, identifying patients with insomnia in the EHR is challenging. 
Prescribed sleep medications are the most common PCP response to an insomnia complaint, 
although some patients are referred for CBTI. Consistent with the larger literature, we found no 
difference between Veterans prescribed sleep medications and those who were not prescribed 
sleep medications in terms of improvements in insomnia severity (f=.15, p=.70) following 
participation in group based CBTI at the Durham VAMC80. Thus, we have defined treatment-
seeking Veterans with Insomnia as those who are: a) prescribed sleep medications; b) 
diagnosed with insomnia; or c) referred for clinic-based CBTI (but not yet treated). 
 
Table 1. Eligibility Criteria Assessment: Methods and Measures 
 
Eligibility Criteria 
Assessment Method 
Level 1 (L1)-Data Pull and Chart Review 
 
Inclusion 
 
≥ 18 years of age 
EHR data pull 
Insomnia Diagnosis OR prescribed sleep medications OR referred for CBTI 
EHR data pull & record review 
Exclusion 
 
Psychotic DO; Bipolar DO; Substance Use; Alcohol Abuse 
EHR data pull 
Dementia; Cognitive Impairment; Epilepsy; Seizure DO 
EHR data pull 
Severe OSA with treatment non-adherence 
EHR record review 
Unstable housing and/or no/unreliable telephone 
EHR record review 
Unstable Co-morbid Sleep DO; and current or prior participation in CBTI 
EHR record review 
No current/prior CBTI participation 
EHR record review 
Nursing Home Residence 
EHR record review 
Level 2 (L2)-Phone Screening, Consent & Enrollment 
 
Inclusion 
 
Insomnia Disorder diagnostic criteria are met per ICSD-3 
DSISD Insomnia DO Module6 
Insomnia Severity Index score of ≥10 
ISI7 
Exclusion 
 
Severe OSA with treatment non-adherence (when unclear from EHR review) 
Phone Screening 
Unstable housing and/or no/unreliable telephone (when unclear from EHR 
review) 
Phone Screening 
Excessive daytime sleepiness 
Epworth Sleepiness >15 
Nighttime or Rotating Shift Work w/in the last year 
Phone Screening 
Confirm no current/prior CBTI participation 
Phone Screening 
Severe Depression and Suicidality 
PHQ-8 >19 and/or SI 
Current Recreational Drug Use 
Drug Use Screener endorsed 
Nursing Home Residence (to complement information from EHR chart review) 
Phone Screening 
EHR=electronic health record; DO=Disorder; ICSD-3= International Classification of Sleep Disorders; 
ISI=Insomnia Severity Index; OSA=Obstructive Sleep Apnea; PHQ=Patient Health Questionnaire; SI=Suicidal 

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Ideation. 
 
C.3 Participant Selection and Recruitment 
We plan to recruit Veterans using both CPRS record review and recruitment from the 
following clinics: Sleep Medicine Clinic; Behavioral Sleep Medicine Clinic; OEF/OIF/OND Clinic; 
Mental Health Clinics and Primary Care. We may utilize 1 or more of the following approaches 
to screen and recruit Veterans into the study:  
 
Approach 1-EHR Recruitment 
We will recruit treatment-seeking Veterans with Insomnia from the Durham VA 
Healthcare System using the criteria in Table 1. In Step 1, we will extract data from the EHR. 
Potentially eligible Veterans will be randomly selected from the data pull for chart review to 
identify those meeting Level 1 (L1) inclusion/exclusion criteria.  
 
Veterans identified as eligible at Level 1 (L1 in Table 1) will receive a letter and Study 
Information sheet describing the study and offering the option to opt out of future study contacts. 
Those not opting out will receive a phone call to assess interest in the study. Interested 
Veterans will be screened for Level 2 (L2) criteria by phone (Veterans meeting these criteria and 
providing verbal informed consent will be invited to participate in the study. Veterans who are 
excluded from the study will be offered tailored interventions for insomnia through our 
Behavioral Sleep Medicine clinic and/or referred to our medical sleep clinic for additional 
assessment or treatment, as needed. 
 
Approach 2-Provider-Assisted Recruitment 
                Approach 2 involves healthcare provider assistance with recruitment. Clinicians in 
clinics throughout the medical center will be provided information about study eligibility and 
basic procedures (see provider email content) as well as a flyer they can provide to patients. 
Clinicians will be asked to refer potentially eligible veterans. Clinicians have reported that 
Veterans often indicate that they prefer that their names and contact information be provided 
directly to study staff. We’d like to make it easy for interested Veterans to get involved in 
research, while protecting the privacy of those Veterans who are not interested in research. 
Towards that end, we would like to allow a clinician to refer a participant directly to our study. 
Dr. Ulmer will send providers an email message to simultaneously recruit for two studies 
involving insomnia treatment; this study and a small pilot study (Path to Better Sleep Pilot 
Study) being conducted by Dr. Ulmer (see provider email content). Dr. Ulmer will attach a flyer 
to the recruitment email that clinicians may provide to interested Veterans. As indicated in the 
email message, providers who identify interested and potentially eligible Veterans can refer their 
patients to the study by adding the study PI or study staff as a co-signer to a CPRS note 
wherein the clinician has documented the Veteran’s wish to be contacted about study 
participation. Dr. Ulmer will record in an excel file located here 
(\\v06.med.va.gov\DUR\HSRD\Insomnia_Self_CBTI_Trial_IRB_2147\Data\Databases\Tracking 
Database\Physician Referrals) the name of patients meeting initial eligibility criteria (i.e., 
diagnosed with insomnia, prescribed sleep medications, and/or referred to the BSM clinic for 
insomnia treatment). Research staff will then follow the recruitment procedures described in 
Approach 1 above, beginning with chart review. In addition to the recruitment process described 
above, research staff may offer presentations at clinic staff meetings to inform providers about 
the study and provide guidance on the referral process.  
Other recruitment procedures will be conducted within the Behavioral Sleep Medicine 
(BSM) clinic. Dr. Ulmer (study PI) may identify potentially eligible patients during the conduct of 

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her clinical work in the Behavioral Sleep Medicine (BSM) clinic; specifically, those who have 
been referred to the BSM Clinic and/or patients awaiting the availability of a provider to begin 
treatment. This will be accomplished by reviewing the chart of patients who have been referred 
to the BSM clinic with an insomnia complaint, and reviewing the BSM Clinic electronic waiting 
list/s. Dr. Ulmer will record in an excel file located here 
(R:\Insomnia_Self_CBTI_Trial_IRB_2147\Data\Databases\Tracking Database\Physician 
Referrals) the name of patients meeting initial eligibility criteria (i.e., diagnosed with insomnia, 
prescribed sleep medications, and/or referred to the BSM clinic for insomnia treatment). 
Research staff will then follow the recruitment procedures described in Approach 1 above, 
beginning with chart review. 
 
Approach 3-Flyer Posting and Brochure Placement 
 
Approach 3 involves placement of recruitment flyers in the VA approved research 
recruitment bulletin boards located throughout the hospital and CBOC clinics. We have also 
created a brochure about the study that may be distributed in clinics.  
 
Exclusion criteria: 1) Severe Obstructive Sleep Apnea with treatment non-adherence; 2) 
unstable co-morbid sleep disorder determined via chart review (e.g., rule out for Narcolepsy, 
rule out for Shift Work Disorder); 3) current or prior participation in CBTI; 4) excessive daytime 
sleepiness; 5) nighttime or rotating shift work within the last year; 6) psychotic disorder 
diagnosis; 7) bipolar disorder diagnosis; 8) recreational substance use/abuse; 9) current alcohol 
abuse; 10) severe depression or suicidality; 11) dementia diagnosis; 12) cognitive impairment; 
13) epilepsy or seizure disorder 14) lack of proficiency in the English language; 15) hearing 
impairment that impedes telehealth intervention; or lack of stable housing and/or no access to a 
telephone. 
 
Rationale for Inclusion/Exclusion Criteria:  
Insomnia Disorder: To be eligible for this study, patients must meet diagnostic criteria for 
Insomnia Disorder (in accordance with the International Classification of Sleep Disorders-3 
(ICSD-3) diagnostic criteria-e.g., at least 3 months of insomnia symptoms; daytime 
consequences of insomnia symptoms; and is not better explained by another condition). Since 
patients are often reticent to discuss insomnia with their providers until they have struggled with 
insomnia for some time, most treatment-seeking patients are likely to meet Insomnia Disorder 
diagnostic criteria. Still, by ensuring that diagnostic criteria are met we will exclude individuals: 
1) with acute sleep difficulties that may resolve without intervention; 2) whose sleep complaints 
are the result of self-imposed sleep restriction (inadequate opportunity for sleep); and those 
whose symptoms are not at a frequency/severity which adversely impacts daytime functioning.  
Excessive Daytime Sleepiness and Severe Untreated Sleep Apnea: Sleep restriction, an 
essential element of CBTI, is contraindicated in those with extreme daytime sleepiness. Since 
extreme sleepiness is common among those with severe untreated sleep apnea, they are not 
appropriate candidates for CBTI because they are unlikely to benefit from CBTI and need sleep 
apnea intervention (i.e., Positive Airway Pressure or other).   
Rotating or Night Shift Work: Promoting a consistent sleep-wake schedule is a central 
treatment target of CBTI. As such, there is no empirical base supporting the use of CBTI among 
those engaged in Shift Work. Similarly, those engaged in night shift work are typically unable to 
entrain a consistent sleep schedule due to shifting back to a more typical sleep schedule, on 
weekends or when not working, to facilitate social interactions. As such, they are unlikely to 
benefit from standard CBTI without adjunctive circadian interventions. Thus, they will be 
excluded from participation. 

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Unstable Co-Morbid Sleep Disorders and Psychiatric Conditions: We are excluding 
those who are engaged in a process of being worked up for identification/diagnosis of sleep 
disorders and/or psychiatric disorders because our ability to determine eligibility criteria is 
hindered by the uncertainty of their condition, and the possibility that we might enroll someone 
who is later determined to be ineligible for the study.      
Psychotic Disorder and Cognitive Impairment: Individuals with these conditions will be 
excluded due to concerns regarding their ability to complete sleep diaries and to fully engage 
with treatment.  
Bipolar Disorder: Sleep restriction can promote manic episodes in those with Bipolar 
Disorder. Thus, an essential element of CBTI (sleep restriction therapy) is contraindicated for 
this population.   
Current Abuse of Alcohol and Recreational Drugs: Individuals engaged in substance 
abuse are excluded because they are unlikely to benefit from CBTI while using/abusing 
substances known to interfere with sleep. 
Nursing Home Residence: Veterans living in nursing homes have little control of their 
sleep environment, which is an essential element of treatment. CBTI in these settings must be 
modified considerably.  
Outside of Catchment area: Veterans living outside of the Durham VAMC catchment will 
be excluded because information in CPRS will not be adequate to screen for inclusion/exclusion 
criteria.  
PCP Assignment: Patients without a Primary Care Physician assignment will be 
excluded because information in CPRS will not be adequate to screen for inclusion/exclusion 
criteria.  
Unstable Housing: Veterans who do not have access to stable housing and/or a reliable 
telephone will be excluded because they may have an irregular sleep schedule or environment 
that would make controlling their sleep environment difficult in order to be adherent in treatment. 
A reliable phone is needed to complete this telephone-based study.  
 
Veterans identified as eligible at Level 1 (L1 in Table 1) will receive a letter and Information 
Sheet describing the study and offering the option to opt out of future study contacts. Those not 
opting out will receive a phone call to assess interest in the study. Interested Veterans will be 
screened for Level 2 (L2) criteria by phone (See Appendix 2a-2f). Veterans meeting these 
criteria and providing verbal informed consent will be invited to participate in the study. For 
veterans who are excluded from the study but interested in further treatment for their sleep, the 
PI will place a clinic note to their PCP or MH provider and/or refer them to the Behavioral Sleep 
Medicine clinic for additional assessment or treatment, as needed. 
 
C.4 Consent Process 
We are requesting a Waiver of Informed Consent and HIPAA Authorization to identify 
and contact potentially eligible Veterans using the processes described above. We are also 
requesting a Waiver of Written Informed Consent as this would be the only document 
connecting patients to this study. By using these approaches that involve both record reviews 
and pre-screening via telephone, we limit the degree to which ineligible Veterans are required to 
travel to the VA to determine their study eligibility. We believe that asking these questions 
presents only minimal risk to potential study participants while simultaneously reducing the 
burden of traveling to the VA to assess eligibility. All potential participants found to be eligible for 
the study, and expressing desire to enroll in the study, will first provide their verbal consent prior 
to collection of baseline measures.  
 

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C.5 Randomization 
Following completion of the baseline assessment, study participants will be randomized 
to either Tele-Self CBTI or HEC in a 1:1 ratio, resulting in 100 participants in each condition. To 
assure equivalency across conditions on important variables, randomization will be stratified by 
Insomnia Severity Index score (≤20/>20: based on findings for Veterans in the VA CBTI 
National Dissemination and presence/absence of a mental health disorder.   
 
 
C.6 Participant Compensation 
Since study participants will experience some inconvenience to participate in this study, 
they will be compensated in the amount of $58 for each of 3 assessment periods. Study 
participants will receive an additional $3 per day (up to $42 for the 2-week period) for 
completion of sleep diaries. In sum, study participants may receive up to $100 for each 2-week 
assessment period, for a total of $300 for completion of all study procedures. As noted above, 
each assessment period involves tracking sleep and wearing the actigraphy device at home for 
a period of 2 weeks and completing questionnaires by telephone.  
Payment occurs in the form of a check to be mailed to the study participant or electronic 
funds transfer within 6 to 8 weeks of completion of each study period. Participants not 
completing the entire study will not be compensated for incomplete study periods. The study 
participant's name, SSN and address will be provided on the Subject Payment Form, in addition 
to information regarding the amount of compensation and study information. Table 2 below 
outlines the Study Timeline, Table 3 outlines the assessment measures employed and timing 
thereof, and Table 4 outlines the contacts with study participants, the purpose of each contact, 
and the time commitment required on the part of participants. These timelines are considered to 
represent the study design and schedule we hope to achieve. However, in some cases we may 
be unable to contact Veterans in strict accordance with this schedule. Study participants who 
are non-responsive to study staff such that the timing of their involvement varies considerably 
from other study participants would be withdrawn from the study. In addition to the contacts 
outlined in Table 4, participants may also receive phone calls to remind them to complete their 
daily sleep diary. This is discussed in greater detail below. 
 
C.7 Study Timeline: The study timeline is summarized in Table 2. 
Table 2.  
Study Activity (Months)  
Yr 1  
Yr 2  
Yr 3  
Yr 4  
 
1 
2 
3 
4 
1  
2  
3  
4  
1  
2  
3  
4  1  
2  
Study Start-Up  
Hire and Train Staff (0-6)  
●  
●  
 
 
 
 
 
 
 
 
 
 
 
 
Create/ test tracking databases (0-6)  
●  
●  
 
 
 
 
 
 
 
 
 
 
 
 
Study Conduct  
Aims 1 & 2: Recruitment (6-30)  
 
 
●  ●  
●  
●  
●  
●  
●  
●  
 
 
 
 
Aims 1 & 2: Intervention (7-32)  
 
 
●  ●  
●  
●  
●  
●  
●  
●  
●  
 
 
 
Aims 1 & 2: 8 Week Follow-Up (8-33)  
 
 
●  ●  
●  
●  
●  
●  
●  
●  
●  
 
 
 
Aims 1 & 2: 6 Month Follow-Up (12-37)   
 
 
 
●  
●  
●  
●  
●  
●  
●  
●  ●  
 
Aim 3: Recruitment and Qualitative 
Data Collection 
 
 
 
 
 
 
 
 
 
● 
● 
● 
● 
 
Evaluation & Dissemination  
Aims 1 & 2 & 3 Analyses (35-40)  
 
 
 
 
 
 
 
 
 
 
 
●  ●  
●  
 
C.8 Measures 
Screening Measures: The following screening measures will be used to assess eligibility.   

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Insomnia Diagnosis: The Duke Structured Interview for Sleep Disorders (DSISD)81 is a 
structured clinical interview for screening and diagnosing sleep disorders and is being revised to 
concord with newer diagnostic nosologies (DSM-V)14 and the ICSD-382. The DSISD Insomnia 
Disorder module will be administered to ensure that Insomnia Disorder diagnostic criteria are 
met. Insomnia Severity Index (ISI)97: The ISI is recommended as the standard for self-reported 
insomnia symptoms, with a score of 10 or more to indicate active insomnia symptoms96,  
 
Contraindicated Hypersomnia Disorders: The Epworth Sleepiness Scale (ESS)84 will be 
used to exclude those with occult obstructive sleep apnea (OSA) and those for whom sleep 
restriction therapy would be contraindicated due to either untreated sleep apnea or hypersomnia 
in the absence of apnea. The ESS is an 8-item measure assessing one’s self-rated typical sleep 
propensity in daily life and is sensitive for daytime sleepiness across a range of settings and 
research paradigms86. An ESS score of >15 indicates the possibility of undiagnosed or 
untreated sleep apnea or narcolepsy and will be used to exclude potential study participants84. 
 
Severe Depression: We will use the Patient Health Questionnaire-887 to screen Veterans 
for severe depression. The validity of the PHQ-8 was established using data from the 2006 
Behavioral Risk Factor Surveillance Survey87. Veterans scoring in the severe depression range 
(>19) will be ineligible for the study but may become eligible at a later date if symptoms decline. 
Dr. Ulmer will ensure that medical providers of Veterans scoring in the severe depression range 
are aware of their mental health status. Veterans endorsing suicidality will be managed in 
accordance with the Suicide Safety Plan  
 
Substance Use/Abuse: We will define alcohol abuse as documentation in the medical 
record of current alcohol abuse. Those with the two most recent AUDIT-C administrations 
documented in the medical record and scored as negative will be eligible for the study. The 
AUDIT-C88, a well-validated 3-item screener for alcohol abuse used in VA89 and primary care 
settings90, to screen out those who are actively abusing alcohol. We will use the clinical scoring 
criteria for men and women respectively. We will use a single item to screen out those engaged 
in recreational drug use91. This item was found to be highly sensitive (100%) and moderately 
specific (73.5%) for detecting those with a drug use disorder and had good sensitivity (81.8%) 
and specificity (72.5%) for laboratory-based evaluation of drug use91.  
 
Table 3. Assessment Measures  
 
Items 
Timing 
 
 
BL 
8 weeks 
6 months 
Background-EHR Data  
VA Sleep & Psychotropic Medications  
n/a 
● 
 
 
Medical Conditions  
n/a 
● 
 
 
Mental Health Conditions  
n/a 
● 
 
 
Background-Self Report 
Demographic Characteristics  
18 
● 
 
 
Medical Conditions  
up to 16 
● 
 
 
Primary Outcome 
Insomnia Symptom Severity: ISI  
7 
● 
● 
● 
Secondary Outcomes 
Actigraphy (WASO, TST and SE)  
n/a 
● 
● 
● 
Sleep Diary (SOL, WASO and SE)  
8 
● 
● 
● 
Fatigue: Multidimensional Fatigue Inventory 
20 
● 
● 
● 
Depression: PHQ-8 
8 
● 
● 
● 
Chronotype: MEQ 
19 
● 
● 
● 
Trauma-related Sleep Disturbances (PSQI 
Addendum) 
10 
● 
● 
● 
International Physical Activity Questionnaire 
11 
● 
● 
● 

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Glasgow Sleep Impact Index 
7 
● 
● 
● 
Insomnia Treatment Knowledge 
Questionnaire 
10 
● 
● 
● 
Ask if participant has accessed CBTI Coach 
and/or Path to Better Sleep 
2 
 
● 
● 
 
Outcome Measures 
Outcome measures will be collected by phone by the project’s research assistant (RA) at 
baseline, 8 weeks, and 6 months. Copies of self-report outcome measures are listed below. 
Insomnia Severity Index (ISI)97: The ISI is recommended as the standard for self-
reported insomnia symptoms96 and will be used as our primary outcome measure. The ISI is a 
7-item questionnaire providing a global measure of perceived insomnia severity. Each item is 
rated on a 5-point Likert scale and the total score ranges from 0-28. The following guidelines are 
recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (sub threshold 
insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). In clinical 
samples, a cut off score of 10 was shown to have the greatest sensitivity and specificity for 
correctly identifying study participants meeting criteria for insomnia diagnosis98. The ISI has 
adequate psychometric properties and has been validated against diary and polysomnographic 
measures of sleep97.  
Sleep Diaries: We will use the Consensus Sleep Diary (CSD)99 to assess the impact of 
Tele-Self CBTI on sleep onset latency (SOL); wake after sleep onset (WASO); and sleep 
efficiency (SE). The Consensus Sleep Diary is the result of an effort to standardize sleep diary 
data collection across sleep research projects. The CSD was developed by an expert panel with 
an eye towards optimal wording, content, and format. Collection of sleep diary data using a 
time-restricted approach (i.e., participant has < 24 hours to record entry) is more valid than 
paper diaries wherein study participants can record data from memory. However, remote 
collection of sleep diaries data is challenging in the VA due to concerns about secure transfer of 
research data across the VA firewall. We will be collecting data using an Interactive Voice 
Response (IVR) system wherein Veterans record sleep data by responding to phone-based 
questions using a telephone keypad was successfully used in our pilot study and is configured 
for this purpose. Participants not reporting diary data will receive a reminder call to complete 
diaries and troubleshoot any reporting difficulties. Participants will also be provided with a paper 
copy of the diary for use in the unlikely event of technical difficulties with the IVR reporting 
system, and a pre-addressed UPS envelope for returning the watch and completed paper sleep 
diaries to study staff. Diary data will be averaged across each 2-week assessment period to 
determine diary-based SOL, WASO and SE. 
 
Wrist Actigraphy: We will use Actiwatch® (Respironics, Inc.) wristwatch style actigraphy 
watches for collecting objective sleep data as used in several prior studies. Actiwatches contain 
a calibrated accelerometer that samples, digitizes, and stores movement activity. When 
interfaced with a computer and Actiware software at the VA research site, a scoring algorithm 
provides estimates of various sleep parameters. Wrist actigraphy is recommended for assessing 
treatment response in adults with insomnia following intervention96. The Actiwatch Spectrum 
Plus device is proposed and includes sensors for light and “off the wrist” which increase scoring 
accuracy. We will average data across each two-week assessment period to determine 
actigraphy-based WASO, Total Sleep Time (TST) and SE.  
Instructions for Home Data Collections: The cover letters and instructions regarding use 
of the Actiwatch and Sleep Diary and timelines for the study will be provided to each patient with 
each delivery of the Actiwatch device.  
Daytime Consequences of Insomnia: As recommended for insomnia research96, we will 
assess fatigue, mood, and quality of life to evaluate the impact of Tele-Self CBTI on adverse 

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daytime consequences of insomnia. The Multidimensional Fatigue Inventory (MFI)100 is a 20-
item measure wherein the responder indicates, using a 5-point Likert scale, the extent to which 
each statement applies to their situation over the previous day). The MFI assesses 5 
dimensions of fatigue, including: general fatigue; mental fatigue; physical fatigue; reduced 
activity; and reduced motivation. The PHQ-8 described above, will be used as our depression 
measure.  
Morningness-Eveningness Questionnaire: The Morningness-Eveningness Questionnaire 
(MEQ) was the first self-report measure developed for the assessment of chronotype and 
continues to be the most widely used measure for this purpose. The MEQ has established 
psychometric properties101. We will use an updated version of the MEQ10 having rephrased 
questions that better conform to contemporary language. In addition, the revised MEQ utilizes a 
discrete item response set in lieu of the original visual response scales, allowing respondents to 
calculate their own score. MEQ scores range from 16 to 86, with lower scores indicating greater 
eveningness and higher scores indicating greater morningness. Total scores are used to 
categorize respondents into 5 categories, as follows: definitely morning; moderately morning; 
neither type; moderately evening; and definitely evening. 
 
Trauma-Associated Sleep Disturbances: The Pittsburgh Sleep Questionnaire Addendum 
will be used to assess PTSD-related sleep quality and has acceptable psychometric properties. 
 
International Physical Activity Questionnaire: The International Physical Activity 
Questionnaire is an 11- item questionnaire that assesses the respondent’s physical activity over 
the previous week. This measure been widely implemented and has been used in the Veteran 
population.  
 
Glasgow Sleep Impact Index: We will be using a 7-item modified version of the Glasgow 
Sleep Impact Index that excludes questions meant for clinical use only. This index is the only 
measure available that is specifically designed to assess sleep-related quality of life impairment. 
 
Insomnia Treatment Knowledge Questionnaire: The Insomnia Treatment Knowledge 
Questionnaire was developed for the pilot study and will be used to assess participant 
comprehension of treatment components. In the pilot study, participants in the intervention  
condition reported higher scores (better understanding of concepts) at post-intervention relative 
to those in the control condition.   
 
The study coordinator will inform patients of randomization arm at the end of the baseline. The 
various time points have windows in which the assessment period should be completed in. 
Participants may start the baseline assessment up to a month after consent. The 8-week 
assessment can start as soon as 6 weeks after starting the intervention period (if all nurse 
phone calls are completed) to no later than 8 weeks after intervention period has started. 
Participants have a 5-week window to start and complete baseline and 8-week assessment 
activities. Participants have a 6-week window to begin and complete 6-month assessment 
activities.   
 
Covariate and Other Measures: Due to their established association with sleep, the following 
variables will be evaluated as potential covariates and included in analyses as appropriate: age; 
gender; body mass index (BMI); co-morbid medical conditions; co-morbid mental health 
conditions; smoking status and pack years; anxiolytic/hypnotic usage; and other medications. 
Self-report information about demographic characteristics and current medical and mental 
health conditions will be collected at baseline. During the 8 week and 6-month Assessments, we 
will ask participants in the Tele-Self CBTI condition if they have sought or received treatment for 
their sleep complaints beyond what was offered in this study.  
 

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C.9 Missing Data: Because the main predictors of interest are collected at baseline, we do not 
anticipate much missing data in these variables. We do, however, anticipate some missing 
values in the longitudinal outcomes owing to dropout or, rarely, patients not completing the 
sleep diaries or returning Actiwatches. Although we did not lose any Actiwatches in our pilot 
study, participants did not return 2 of 162 devices (1%) in a past trial4. If the missing values are 
related to other measured patient factors, such as age, comorbidities, or employment status (as 
we have seen in previous studies), then multiple imputation (MI) provides a framework for 
incorporating information from these auxiliary variables while still preserving a parsimonious 
main treatment effect mode. This framework is described as a significant advantage in 
recommendations from the Panel on Handling Missing Data in Clinical Trials. Depending on the 
type and scope of missing data for other longitudinal variables, as a sensitivity analysis, MI will 
be conducted via the SAS procedure PROC MI or the SAS macro IVEware. A general linear 
model for each outcome variable will then be applied to each of the imputed datasets, and 
estimates combined using Rubin’s rules as implemented in PROC MIANALYZE. 

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Table 4. Contacts with Participants 
 
STUDY CONTACTS 
Week# 
Purpose of Contact 
Measures 
Time Commitment/Contact Modality 
0 
TELEPHONE-BASED SCREENING 
Shift Work Question 
Drug Use Screener 
Prior participation in CBTI Question 
DSISD 
Epworth Sleepiness Scale 
Insomnia Severity Index 
PHQ-8 
30 minutes/phone call 
0 
CONSENT AND ENROLL 
 
20 minutes/telephone 
2 
BASELINE ASSESSMENT 
o Participant calls IVR sleep diary 
system daily for 2 weeks 
o At end of 2 weeks, participant 
completes baseline questionnaires by 
phone  
o Following questionnaire completion, 
participant is randomized and 
informed of assigned treatment arm 
by phone 
Adverse Events 
Demographic and Service Information 
Comorbidity Questionnaire 
Insomnia Severity Index (ISI) 
Multi-Dimensional Fatigue Inventory (MFI) 
Morning Eveningness Questionnaire (MEQ) 
Pittsburgh Sleep Quality Index (PSQI) 
Glasgow Insomnia Index 
IPAQ short phone (physical activity) 
Insomnia Treatment Knowledge Questionnaire 
Sleep Medication Question 
COVID questions 
5 minutes daily/IVR 
40-50 minutes/phone call  
3-8 
INTERVENTION ARM 
Interventionist calls with participant to 
support treatment engagement and 
adherence.   
Intervention Adherence Questions 
6 nurse contacts @ 20 mins/call 
 
3-8 
HEALTH EDUCATION ARM 
Interventionist calls with participant to 
ensure equivalent contact time across 
arms.  
 
6 nurse contacts @ 20 mins/call 
 

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STUDY CONTACTS 
Week# 
Purpose of Contact 
Measures 
Time Commitment/Contact Modality 
     9-10 
8 WEEK ASSESSMENT  
o Participant calls IVR sleep diary 
system daily for 2 weeks 
o At end of 2 weeks, participant 
completes 8-week assessment 
questionnaires by phone  
 
Adverse Events query 
Insomnia Severity Index (ISI) 
Multi-Dimensional Fatigue Inventory (MFI) 
Morning Eveningness Questionnaire 
PSQI addendum 
Glasgow Insomnia Index 
IPAQ short phone 
Insomnia Treatment Knowledge Questionnaire 
PHQ-8 
COVID questions 
Sleep medication and Other Treatment for your Sleep 
Complaint 
Intervention arm only: Treatment Acceptability/use  
5 minutes daily/IVR 
<50 minutes/telephone 
27-28 
6 MONTH ASSESSMENT  
o Participant calls IVR sleep diary 
system daily for 2 weeks 
o At end of 2 weeks, participant 
completes 6-month assessment 
questionnaires by phone  
Adverse Events query 
Insomnia Severity Index (ISI) 
Multi-Dimensional Fatigue Inventory (MFI) 
Morning Eveningness Questionnaire 
PSQI addendum 
Glasgow Insomnia Index 
IPAQ short phone 
Insomnia Treatment Knowledge Questionnaire 
PHQ-8 
COVID questions 
Sleep medication and Other Treatment for your Sleep 
Complaint 
5 minutes daily/IVR 
<50 minutes/telephone  
 

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Study Interventions 
 
Tele-Self CBTI: The nurse interventionists will make an introductory call and set up a weekly call 
appointment time. As noted above, Tele-Self CBTI is comprised of two treatment components: 
1) Self-management via our workbook entitled, “Improve your Sleep: A Self-Guided Approach 
for Veterans with Insomnia” with Session Guides; and 2) telephone-based nurse support. Our 
Tele-Self CBTI workbook includes the following typical CBTI treatment components: Sleep 
Restriction; Stimulus Control; Cognitive Therapy; Relaxation; and Sleep Hygiene Education93. 
We will deliver Tele-Self CBTI across 6 weekly telephone contacts of 20 minutes or less. Table 
5 describes the treatment modules and content of each telephone session, and the relative 
timing of treatment components. 
Table 5. CBTI Treatment Components and Sessions  
Module: Content  
Veteran Workbook 
Readings 
Nurse Support 
Sleep Diary 
Weekly  
Weekly 
Daily 
1: Sleep Education; Sleep Diary Instructions  
Session 1 (page 5) 
X 
X 
2: Sleep Restriction Therapy  
Session 2 (page 15) 
X 
X 
3: Stimulus Control  
Session 3 (page 19) 
X 
X 
4: Sleep Hygiene; Cognitive Therapy 1  
Session 4 (page 31) 
X 
X 
5: Relaxation; Cognitive Therapy 2  
Session 5 (page 39) 
X 
X 
6: Relapse Prevention  
Session 6 (page 51) 
X 
X 
 
Health Education Control (HEC): To assess the impact of provider phone contacts on outcomes, 
patients randomized to HEC will receive 6 weekly phone calls from a study nurse. Consistent 
with phone contacts in the intervention arm, HEC phone contacts will last no more than 20 
minutes and will match as closely as possible call duration with Tele-Self CBTI participants. 
Sleep-focused content will be prohibited during HEC calls. Health education scripts in HEC were 
used in a previous trial94 and address a range of health topics (i.e., colorectal and skin cancer, 
healthy backs, medication management, heart healthy foods, lower sodium diets and how to 
prevent heart problems. At the end of the study, HEC participants will be offered either face to 
face group-based treatment or Tele-Self CBTI treatment through our Durham VA Behavioral 
Sleep Medicine Clinic. 
 
Provider Training and Treatment Fidelity: Dr. Ulmer will train the research nurses to provide 
Tele-Self CBTI using an approach informed by the VA CBTI dissemination training model. This 
approach will ensure the research nurses have a thorough understanding of all CBTI treatment 
components. Training case sessions will be recorded and evaluated for treatment fidelity using 
the Yale Adherence and Competence Scale (YACS)95. The research nurse will also be trained 
in emergency procedures for addressing suicidal ideation (SI) or homicidal ideation (HI) 
revealed during telephone sessions, including assistance from the Veterans Crisis Line. 
 
 
 

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D. Qualitative Study (Aim 3) 
We will conduct qualitative interviews with providers and administrators in order to gain 
information on barriers to implementation of self-management CBT-I the primary care setting.  
 
D.1 Study Design 
We will conduct focus groups and/or individual interviews with nurses and administrators 
from the Durham VAHCS to participate in this qualitative component of our research/study. 
Each participant will participate in an interview or focus group using a script to elicit responses.  
 
D.2 Study Population 
The target population will be employees of the Durham VAHCS who work as a nurse or 
administrator. Local union nurse representatives will be notified per proper procedures/protocols 
prior to contacting potential nurse participants. Although supervisors may provide a list of nurses 
by clinics, they will not be involved in the conduct of any other research activities. Supervisors 
will not be notified of identifiable, individual level employee participation or provided individual 
level data. Nurse employment will not be impacted by participation status. Participation is 
voluntary and confidential. Steps will be taken to protect the identity of the respondents. The 
identity of the respondents will be kept confidential by the research team and identifiers will be 
kept separate from the coded data. Results will be reported in aggregate and individual quotes 
when used will not be identifiable.  
 
D.3 Participant Selection  
We plan to conduct focus groups and/or individual interviews with up to approximately 
20-30 nurses and up to approximately 5 clinic administrators from the Durham VAHCS. We may 
recruit and enroll/consent more than the above numbers to reach our targets (up to 50 nurses 
and up to 10 administrators). Potential participants will be purposefully sampled based on 
criteria such as site type (i.e., CBOC and hospital) or location (i.e., rural and urban), with a 
randomly generated priority order for contact if necessary by sites (based on number of nurses 
at each site) or all nurses at that site if numbers are small.  
 
D.4 Subject Recruitment 
 
Approach #1 – Email Recruitment 
 
Step 1:  A list of nurses at the Durham VAHCS Primary Care and Sleep Clinics will be obtained 
by emailing and/or calling the facility’s Nurse Management Leaders and/or Clinic 
Managers to identify the appropriate healthcare providers. We will provide an overview 
of the study during our initial contact with these individuals. We will also obtain and 
confirm the email group name for nurses within each clinic for use in step 2 of the 
recruitment process. Multiple emails and/or phone calls may be made to collect the 
nurse email list and confirm the email group name/s. 
 
Step 2:  Using the email group names provided by clinic managers or their staff, we will send 
an introductory email to Durham VAHCS Nurses identified in Step 1. This introductory 
email will provide nurses with study information about the study in addition to 
explaining a procedure for opting out of future contacts. Nurses who do not want to 
receive subsequent contacts about the study will be instructed to “opt out” by calling 
and/or emailing the principal investigator or study coordinator. 
  

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Step 3:  Nurses will then be selected for receipt of recruitment email from the email group lists 
obtained in Step 1, with those who opted out in Step 2 being excluded. Administrators 
will be selected based upon their role in the system – we will endeavor to obtain a 
range of perspectives about potential barriers and facilitators to implementing Tele-Self 
CBTI in clinical care. Selected nurses and administrators will receive a personalized 
email and/or phone call wherein they will be asked if they would like to participate in 
the proposed study. Multiple emails and/or phone calls may be made to reach the 
potential participant. We may also use MS Teams to communicate and possibly 
schedule the interview/focus group. Potential participants will not officially “opt in” to 
complete the interview until they are contacted by phone or in person and provide 
verbal consent to participate in the study. If the study staff receives no response after 
multiple attempts, we will assume the nurse/administrator is not interested in 
participating in the study.   
 
Approach #2: Staff Meeting Recruitment Durham VAHCS 
 
Step 1:  A phone call will be made to each clinic lead to schedule a presentation during a 
regularly scheduled staff meeting. During the meeting we will provide an overview of 
the study and answer any questions.  
 
Step 2:  During the presentation, nurses and administrators who are interested in participating 
will be provided with the contact information of the PI and study staff for purposes of 
reaching out to express their interest in participating in the study or to receive 
additional information. This will help keep participation anonymous among the clinic 
staff.   
 
Approach #3 –Email Recruitment VISN 6 Primary Care (if necessary following Approaches #1 
and #2) 
 
Step 1:  Study staff will send an email to the VISN 6 primary care ACOSs (excluding the 
Durham VA) and their administrative assistants if available to introduce them to the 
study and ask them if we may contact their various clinic nurse managers to discuss 
recruitment within their clinics. We may use email group names that are provided by 
the nurse managers or use a list of nurses obtained from them to send direct emails to 
nurses. If an ACOS does not want their facility to participate we will not attempt to 
contact any nurse or administrator for this study at that facility. Non-responding 
ACOSs will be contacted by phone to obtain this information. More than one phone call 
may be made to reach the non-responding ACOSs. 
 
Step 2:  Once nurse email groups or individual nurse lists are obtained the study staff will 
continue to follow steps 2 and 3 from Approach #1. 
 
Potential participants will be purposefully sampled based on criteria such as site type (i.e., 
CBOC and hospital) or location (i.e., rural and urban), with a randomly generated priority order 
for contact if necessary by sites (based on number of nurses and as described in more detail 
below), to be contacted by email, phone, and MS Teams to discuss participation in the study 
and be scheduled for the interview. 
 
 
 

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D.5 Consent Process 
We request a waiver of documented informed consent. An information sheet will be 
emailed to the potential participant. This aim of the study will be fully explained prior to initiating 
any study procedures, and verbal consent will be required for study participation. Since most 
nurses/administrators will only be available to engage in the study interview by phone, verbal 
consent with phone or MS teams interview is the most feasible option for this research. 
Furthermore, there are no anticipated physical, psychological, legal, social, genetic, or 
economic risks associated with this research study.  
The nurse/administrator’s email address or telephone number used during the 
recruitment process will not be retained with study data collected during the interviews. All the 
study data collected during the demographic survey and semi-scripted interview will be given a 
Study ID number. 
 
Study participants will be verbally informed that the research interview will be recorded 
via MS Teams for later analysis and will be used for purposes pertaining only to this research 
study. They can also end the interview at any time without penalty. When the audio recording is 
turned on the study staff conducting the interview will obtain verbal assent for the recording.  
This assent process will be captured on the recording prior to recording the interview. The 
participant can decline questions they don’t want to answer. When the recording is transcribed 
any names or other identifiers will be removed. 
 
D.6 Participant Compensation 
Consistent with VA policy, VA employees will not receive compensation for study 
participation.   
 
D.7 Measures 
A focus group interview guide has been created to guide qualitative interviews. The 
interviews will be recorded, transcribed, and coded, which is described in further detail in data 
analysis. 
 
E. Data Management (Aims 1-3) 
 
Study tracking data will be securely stored in a SQL server database created for this project. 
Members of the study team will be granted role-based permissions to connect to the database 
to enter, view, and update data using a Microsoft Windows tracking application created and 
supported by the Durham HSR&D software development team. We have used this tracking 
software for multiple prior studies. Because many processes for identification, enrollment, and 
follow-up of participants are similar to prior studies, we can easily customize the database and 
software to meet the specific needs of the proposed project. The database allows us to track: 
the status of each patient (eligible, enrolled, refused, etc.), results of medical record reviews, 
results of screening interviews, and all tasks due for each participant (e.g., follow-up 
assessments). We are also able to randomize participants within this database, as the 
randomization sequence and necessary stratification variables can be imported. Customized 
reports allow the research team to identify daily tasks in need of completion, as well as flow 
charts to monitor overall study progress. Screening and outcome measures (except for the 
sleep diary and actigraphy data) will be defined and entered using REDCap™, a web-based 
survey tool also running on a secure server behind the VA firewall. The REDCap software is a 
web-based survey tool running on HSR&D computer systems operated by VA OI&T personnel 
on behalf of HSR&D.  At no time will the email function in REDCap be used for this project. Only 
data can be entered into this web-based survey tool. The data is stored on the servers at 
HSR&D and the coordinators and master statistician will have access to the raw data. The 

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tracking database is in the study folder at the location identified above. The study tracking 
database containing Study ID, full names, full SSN, addresses, phone numbers, and eligibility 
(yes/no), mailed recruitment letter (yes/no), and phone screened (yes/no), treated in clinic 
(yes/no) and will be protected using passwords and study group policies.  Staff also have 
created a couple excel datasheets stored only in the study folder for use during active 
recruitment in order to track Actiwatches which contain subject ID, Actiwatch number and log 
in/out dates, and an excel sheet for asking study-related questions to the PI. In addition, an 
excel sheet in the protected study folder will be used to store contact information of potential 
qualitative participants as well as record contacts and participation status (date of consent, 
refusal, etc.). Consent and demographic data will be collected via REDCap using a subject ID.  
Data will be accessible to only personnel on current staff listing who need to contact subjects, 
such as the project coordinators, research assistants, and PI. Once a study staff member is 
removed from the staff list their privileges will be revoked and they will no longer have access to 
the study folder or study cabinet.  
The tracking database, REDCap survey results, sleep diary and actigraphy datasets will 
respectively use IVR and Actiware software and be linked via participant study identifier for 
analyses. The Actiwatch, as well as any paper sleep diaries which have subject ID on them will 
be mailed back via UPS carrier. The watch contains subject ID, initials, and actigraphy (motion) 
data for the most recent participant. Actigraph data can only be accessed/downloaded via 
specialized licensed software located on the project coordinator or RA computer. Statistical 
analysis will be perfumed using Actigraph data will be analyzed by Actiware software that 
comes with the device, (Phillips Respironics, Andover MA), SAS, (SAS Institute, Cary, NC) and 
qualitative data will be organized using AtlasTi (Scientific Software Development, Berlin, 
GmbH). 
 
E.1 Data Summary (Aims 1 & 2): Descriptive statistics, including graphical displays, will be 
used to summarize all study variables, both overall and by intervention group. Evidence of 
imbalance in baseline characteristics will be noted and discussed as to whether they are 
clinically significant. As recommended by Committee for Proprietary Medicinal Products108 
guidelines, we will consider sensitivity analyses adjusting for these baseline characteristics to 
ensure that an observed intervention effect is not due to baseline imbalance. Trajectory plots 
and frequency distributions will be used to explore longitudinal outcomes. We do not anticipate 
substantial deviations from symmetric, normal distributions for the study outcome variables. 
Additionally, correlation patterns over time, both overall and by intervention group, will be 
examined via scatter plots. The main conclusions drawn from this trial will be based on the pre-
specified primary and secondary hypotheses outlined below and will be tested with two-sided p-
values at the standard 0.05 level. All statistical analyses will be performed using the SAS 
software package (Cary, NC); the Durham HSR&D Center of Innovation maintains the current 
SAS release on the Durham VA hospital servers.  
 
E.2 Intent to Treat Analyses (Aims 1 & 2): All primary and secondary analyses focus on the 
effect of the intervention compared to control. We, therefore, plan to use the intent-to-treat 
assumption for all analyses; participants will be analyzed as part of the group to which they are 
randomized, regardless of intervention adherence.  
 
Hypothesis 1: Relative to Health Education, participants randomized to receive Tele-Self CBTI 
will have greater improvements in insomnia severity, as measured by the Insomnia Severity 
Index (ISI), at 8 weeks. The ISI is a continuous measure wherein lower scores indicate less 
severe insomnia symptoms. A general linear model will be used to estimate changes in ISI over 
time and test the primary hypothesis. Because of the small number of time points, we will apply 

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an unstructured covariance matrix to take into account the within-patient correlation between 
repeated measures over time. The predictors in the model will include a dummy coded time 
effect and an indicator variable for Tele-Self CBTI interacting with the time effect. The mean 
structure of the model will have the form: Y = β 0 + β 1*6wk + β 2*(month6) + β 3*(Tele-Self 
CBTI*6wk)+ β4*(Tele-Self CBTI*month6) + β 5*(age) + β 6*(baseline ISI), and model 
parameters will be estimated using the SAS procedure MIXED (Cary, NC). Note that this model 
is a constrained intercept model, which assumes a common baseline mean109. We will formally 
evaluate the intervention effect by testing that β 3 differs from zero and report the mean 
difference and corresponding 95% confidence interval. A mean difference significantly less than 
zero provides evidence that Tele-Self CBTI patients have greater improvements in ISI at 8 
weeks. The model will also include centered, stratification variables of age (≤50/>50 years), 
baseline ISI (≤20/>20), mental health disorder status (presence/absence), psychotropic 
medication (use/non-use) and sleep medication (use/non-use) as recommended in the CPMP 
guidelines108.  
 
Hypothesis 2: Relative to Health Education, participants randomized to receive 
Tele-Self CBTI will have greater improvements in subjective sleep (per diary SOL, WASO, and 
SE), objective sleep (per actigraphy WASO, TST, and SE), fatigue, depression symptoms, and 
QOL at 8 weeks. As described above, sleep parameters (both diary and actigraphy) are 
recorded daily during each of the three 2-week assessment periods. Daily values will be 
averaged across each 2-week period, resulting in three repeated continuous outcomes for each 
of the sleep parameters, including baseline, 8 weeks, and 6 months. Treatment group 
differences at 8 weeks and 6 months for these subjective and objective sleep measures will be 
tested via the same general linear model as specified above for the primary hypothesis. 
Similarly, the fatigue, depression symptoms and QOL outcomes will also be analyzed with a 
general linear model as specified above for the primary hypothesis. Again, PROC MIXED will be 
used to estimate and test the appropriate model parameters, and the mean difference and 
corresponding 95% confidence intervals will be reported.  
 
E.3 Sample Size Considerations (Aims 1 & 2): Our sample size estimates are based on the 
Hypothesis 1 primary outcome – Insomnia Severity Index. Because this is a longitudinal study 
with repeated measurements on each subject, mean change is estimated with increased 
precision. In sample size calculations, the increase in precision can take into account the 
correlation between repeated measures. With Tele-Self CBTI, we anticipate seeing smaller 
effects than might be seen with in-person CBTI. Additionally, our comparison group receives 
more than usual care, again leading to smaller effects. In a recent meta-analysis, the effect of 
CBTI on ISI yielded large Hedge’s g effect sizes of 0.98. Conservatively, we then base our 
sample size estimates on an effect size of 0.5; this translates into a relative mean improvement 
on the ISI of at least 2.8. Assuming a baseline SD of 5.8, a repeated-measures correlation of 
0.6 (both quantities estimated from previous studies[37,52,54,114], and a type-I error of 5%, we will 
need to have 73 patients in each arm to detect a relative mean improvement of 3 on the ISI with 
90% power. To account for dropout and possible deviations from our assumptions, we plan to 
enroll and randomize 100 patients in each arm (total sample size n=200). With this sample size, 
we will also have adequate power to examine our secondary outcomes. For example, previous 
studies of SE show a baseline SD of 12.5 and repeated-measures correlation of 0.7. With our 
projected sample size, we will have 90% power to detect a relative improvement in SE of at 
least 6.2. The repeated-measures design option in PASS115 was used for all calculations. 
E.4 Data Analysis (Aim 3) 

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Focus groups will be comprised of 8-10 nurses, and the exact number of focus groups 
will be dictated by thematic saturation102. Individual nurse interviews will be conducted as 
needed to explore in greater depth concepts discussed in focus groups and/or due to 
scheduling. Individual interviews will be conducted with Administrators to obtain their 
perspective on the barriers/facilitators to consider when implementing Tele-Self CBTI. Focus 
groups and individual interviews will be conducted by a trained qualitative specialist using a 
moderator guide developed by Drs. Ulmer and King (Appendices). The moderator guide was 
developed in accordance with Weiner’s Theory of Organizational Readiness for Change (ORC), 
which refers to the extent to which organizational members are prepared to make changes in 
organizational policies/practices necessary to support innovation (change commitment) and 
their perceived ability to do so (change efficacy). Attributes impacting ORC include change 
valence (perceived value of the innovation) and information about perceived task demands, 
resource availability, and situational context (e.g., competing demands). Dr. King has previously 
utilized ORC to understand implementation of programs by VA facilities103, including 
implementation of lung cancer screening104, currently funded QUERI/HSR&D projects 
(Spreading Healthcare Access, Activities, Research and Knowledge Partnered Research 
Initiative) and an implementation evaluation of tele dermatology on Veterans’ access to 
dermatology. Participants will also complete a questionnaire to characterize sample 
demographics and work history (e.g., tenure as nurse and with VA). Focus groups will be 
approximately 1 hour and individual interviews will be approximately 20-30 minutes. Focus 
groups and interviews will be conducted, recorded, and transcribed using the functionalities of 
MS Teams (REFERENCE: Research Cybersecurity FAQ - Applications (sharepoint.com)). 
Recordings and transcripts will be downloaded and saved to the study folder, which is on a 
secure server behind the VA firewall. Recordings and transcripts will be deleted once saved to 
the study folder. A structured notetaking form/template for each focus group and interview will 
be used to organize and compile qualitative data. Rapid qualitative analysis will be used to 
analyze notes, supplemented with the recordings/transcripts. Matrix techniques will be used to 
facilitate data analysis and presentation. We will develop a table based on the guide and 
organized by question/domain. Data extracted and summarized from notes and 
recordings/transcripts will be used to populate the table for each focus group/interview and 
summarized across, supported by illustrative, exemplar quotes, and consolidated into matrices 
to identify and describe aspects of organizational readiness for change, for example.105  
 
F. Handling of Unexpected and Adverse Events  
 
F.1 Risk/Benefit Assessment 
This study involves a low risk cognitive-behavioral intervention. There are no investigational 
drugs or devices being tested in this study. The risks of this intervention are no greater than 
those incurred during a standard clinical intervention for insomnia. The main risk of study 
participation is the possibility of becoming upset when answering personally probing questions 
on the study questionnaires, or during engagement in the intervention. Participants will have the 
option of refusing to answer distressing questions or withdrawing from the study at any time 
without adversely affecting their ongoing care. Hence, the risks of such discomfort are mitigated 
by the options offered to participants. The PI will report any serious, unexpected, and study-
related adverse event or unanticipated problem to the patient’s provider and local IRB according 
to the institution’s requirements (5 business days). The IRB will review all adverse events during 
continuing review, which will likely occur annually. All adverse events will be reported in the 
annual report to the VAMC IRB.   
The Qualitative study involves interviews that will be approximately 20-30 minutes or 

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focus groups will be approximately 1 hour. Risks of discomfort is assessed to be low. 
Participants are informed they can refuse to answer questions or drop out at any point of 
participation.  
F.2 Adverse Events 
While we do not anticipate adverse events related to study activities, all adverse events 
that do occur will be reported per Durham VAMC requirements. All Serious, Unanticipated and 
Related adverse events will be reported to IRB within 5 business days of hearing of the event. 
All other adverse events will be reported at continuing review. 
 
F.3 Safety Plan for Suicidal Ideation 
During study screening and each assessment period, a Research Assistant (RA) will 
administer the Patient Health Questionnaire (PHQ-8) to assess depression. If patients endorse 
suicidal ideation  or  express clinical warning signs of elevated risk of self-harm (e.g., severe 
depression), study staff will gather more information from the participant, including information 
about suicidal plan, means, intent, and history of suicidal behavior, by administering a structured 
screener, the P4 Screener, to assess the potential for suicide risk .  
Patients with greater than minimal risk as assessed by the P4 will be excluded from the 
study, but not dropped from study participation if already enrolled, and offered a warm hand off 
to the VA Crisis Line in accordance with the approach suggested by the VA Crisis Line (see VA 
Veterans Experience website-document entitled Veteran In Crisis Handout.pdf). If they decline 
the warm hand off to the crisis line, the participant will be informed that a study clinician may 
contact him/her to talk more about his/her suicidal ideation. The study coordinator will obtain 
current contact information for the participant and inform Dr. Ulmer or Dr. Beckham, study 
clinicians who are trained in suicide assessment, who will contact the participant as necessary 
to ensure participant safety.   
 
At their professional discretion, Drs. Ulmer or Beckham will contact and assess the 
patient over the phone and take appropriate action. Assessment will include evaluation of 
suicidal plan, intent, means, history of suicidal behavior, and other relevant clinical information. 
If the patient is deemed to be at moderate to high risk of suicide, Drs. Ulmer or Beckham will 
provide education to the patient regarding resources at VA and in the community for psychiatric 
emergency care. Patients will be urged to seek acute mental health care, and where possible, 
Drs. Ulmer or Beckham will help establish a follow-up plan for this care.  
 
If the patient is deemed to be at imminent risk for suicide, he/she will be asked to come 
to his/her local ER or VA ED immediately. If he/she is unwilling or unable to go to the nearest 
ER or ED, Drs. Ulmer or Beckham will follow DVAMC policy for contacting local authorities for 
assistance in securing and transporting the patient to a hospital/mental health facility where 
he/she will receive appropriate help. When possible, Drs. Ulmer or Beckham will remain in 
contact with the patient until local authorities have secured the patient. Following the contact, 
Drs. Ulmer or Beckham will document the incident in CPRS and will notify via CPRS the 
patient’s VA primary care physician and/or mental health provider. 
      
F.4 Withdrawal of Participants 
Veterans self-reporting current suicidal ideation at any time during the study protocol 
(both screening and study procedures) may be excluded/withdrawn from the study if the 
Principal Investigator deems that their continued involvement in the study could adversely 
impact the patient.   
 
F.5 Data and Safety Monitoring 
Coded data with direct identifiers removed (i.e., name, address, telephone numbers, 
SSN, DOB) will be placed at VINCI. We will be using REDCap a VA Intranet Web application 

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approved by VA and run by VA VIReC. The REDCap software is web-based but participants will 
be interviewed over the phone and data will be entered by study staff behind the VA’s firewall. 
The data are housed on a VA Informatics & Computing Infrastructure (VINCI) Server. Data from  
the Actigraph device will be downloaded to tour local server behind the VA firewall at  
\v06.med.va.gov\DUR\HSRD \Insomnia_Self_CBTI_Trial_IRB_2147    HSR&D servers 
are located in a secured area at 508 Fulton St., Room FG104-1, Durham, NC 27705. All VA 
research personnel who have access to VHA records are instructed, in accordance with VA 
policy, on the requirements of Federal privacy and information laws and regulations, VA 
regulations and policies, and VHA policy. All study personnel who are VA employees working 
within the VA system have fulfilled all required HIPAA and other VA security and privacy policy 
training requirements and have agreed to follow guidelines pertaining to the protection of patient 
data. All research staff sign VA Rules of Behavior, and all study staff are up to date with VHA 
Privacy Policy Training and the VA Office of Cyber and Information Security Awareness Training 
Course. The data security and privacy procedures summarized in that course include logging off 
or locking the computer when walking away from it; no sharing of access codes, verify codes or 
passwords; not allowing anyone else to use the computer under one’s password; and disposing 
of sensitive information using VA-approved methods (e.g., shredder bins). Access to study data 
will be removed for all study personnel when they are no longer part of the research team. 
 
This is a minimal risk intervention for insomnia and we do not anticipate any safety 
issues related to the intervention. Patient activity will be monitored for Serious adverse events 
during the intervention period by intervention nurses.  
 
Screening, baseline, and outcomes data will be collected via telephone at baseline, after 
the intervention (week 6) and at the 6-month follow-up. Suicidality will be assessed across the 
same timepoints, as part of the PHQ-8. The Suicide Safety plan will be implemented for patients 
endorsing suicidality during completion of the PHQ-8 at any point in study conduct, as 
discussed above. 
 
Any Serious Adverse events will be filed using IRB paperwork and filed in study binder 
which will be stored in a locked cabinet.  
  
 
 
 
 

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Privacy, Confidentiality, and Information Security 
1. Lists of Data Reviewed and/or Collected for Screening/Recruitment and 
Conduction of Study:  
The Personal Health Information that will be obtained, used, and/or shared for this study 
includes:   
Identifier(s) 
Source(s) of Health Information 
 Names 
 Medical history & physical exam 
information 
 All geographic subdivisions smaller than a 
State, including street address, city, county, 
precinct, and zip code.  Describe: Home address 
including house number, street, city, state, zip 
code and PO Box number. 
 Photographs, videotapes, audiotapes, 
or digital or other images. Audio 
recordings of participants’ intervention 
calls. MS Teams audio recordings of 
qualitative interviews/focus groups. 
 All elements of dates (except year) for dates 
directly related to an individual, including birth 
date, admission date, discharge date, visit or 
treatment dates, etc.; and all ages over 89,  
Describe: Date of birth; Date of enrollment, date 
of phone-based Sleep Diary entries, date of 
follow-up surveys, dates of primary care and 
specialty visits.   
 Biologic specimens (e.g., blood, 
tissue, urine, saliva). Describe: 
 Telephone numbers 
 Progress notes 
 Fax numbers 
 Diagnostic / Laboratory test results 
 Electronic mail addresses (qualitative 
participant emails) 
 Operative reports 
 Social Security Numbers 
 Imaging (x-ray, CT, MRI, etc.) 
 Medical record numbers 
 Discharge summaries 
 Health plan beneficiary numbers 
 Survey / Questionnaire responses 
 Account numbers 
 Billing records 
 Certificate and/or license numbers  
 HIV testing or infection records 
 Vehicle identifiers and serial numbers, 
including license plate numbers  
 Sickle cell anemia information 
 Device identifiers and serial numbers 
 Alcoholism or alcohol use information 
 Web Universal Resource Locators (URLs) 
 Drug abuse information 
 Internet Protocol (IP) address numbers 
 Mental health (not psychotherapy) 
notes 
 Biometric identifiers, including finger & voice 
prints 
 Psychological test results 
 Full-face photographic images and any 
comparable images 
 Genetic testing 
 Any other unique identifying number, linked 
study ID, characteristic, or code, describe:  
Demographic data, study ID 
 Other, describe:   Actigraph device 
data 
 

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2. Data and/or Specimen Acquisition:   
Data for this study will be collected through (check all that apply): 
  Prospective data and/or specimen collection obtained from participants.  Provide 
description of processes:  Initial screening information will be gathered through a 
medical record chart review and phone screening process. The phone screening 
process may also occur in person if the veteran was identified as potentially eligible and 
interested during a BSM clinic appointment such as a sleep orientation session.  
General study data will be obtained through telephone-based interviews and completed 
questionnaires/surveys. Actigraphy data will be collected via a device worn by the 
patient, which is described above in greater detail. Sleep diary information will be 
collected using an IVR system or on paper sleep diary. HSR&D IT staff has developed a 
process for extracting data from the IVR system into an excel file. This file resides in a 
folder located behind the VA firewall.   
 
Additional study data may be obtained during the intervention phase when the 
interventionist is working with the participant over the phone. Any important information 
related to the study will be saved in the electronic study folder. Qualitative study data 
are collected by recording interviews, transcribing, and then coding data, which will be 
connected to the subject by subject ID.  
 
  Retrospective data collection and/or specimens obtained from medical chart 
review/data access.  Describe how data will be obtained (e.g., fileman, CDW, etc.):  
     . 
  Retrospective data collection and/or specimens obtained from an IRB-approved 
data and/or specimen repository.  Indicate the repository source including name, VA 
location, and IRB number:       . 
Note:  for data and/or specimens obtained from a VA approved data repository, a Data 
Use Agreement (DUA) must be executed prior to obtaining data and/or specimens.  See 
VHA Handbook 1200.12 for further information. 
 
3. Level of Data:   
The following level(s) of data will be acquired/maintained for this study (check all that 
apply): 
  Identified (e.g., names, addresses or other identifiers included)  
  Coded (direct and/or all identifiers removed, but study code/ID included)  
  De-Identified (all HIPAA 18 and study ID/code removed): 
  Verified Statistically  
 
OR 
  Verified by Absence or Removal of HIPAA 18 and study ID  

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  Limited Data Set 
  Other: Describe:        
 
4. Location of Data and/or Specimens, and Data Retention Plan:   
A. Data Location: Data will be stored electronically, in the study folder at 
\\v06.med.va.gov\DUR\HSRD\Insomnia_Self_CBTI_Trial_IRB_2147. Initial REDCAP survey 
data are housed on a VA Informatics & Computing Infrastructure (VINCI) Server. The IVR 
phone surveys are collected through the IVR reporting system that saves to an HSR&D 
server. Electronically stored data will include chart reviews, questionnaires, actigraphy data, 
and IVR reported sleep diaries. If the IVR phone system goes down, as backup, participants 
should record sleep diaries on paper. That information is then entered electronically, and the 
paper forms are stored in VA locked filing cabinets. Recording of intervention phone calls 
will be done utilizing VA approved software installed and configured by VA OI&T personnel 
after sanctuary exemptions have been obtained. Currently this is done using Sparky. Once 
Sparky is no longer allowed, we will  transition to Audacity, WebEx, or another application 
having RMS approval. The data will continue to be saved on a restricted study folder on the 
R drive. VA laptops used to collect study data will use FIPS 140-2 validated encryption. The 
audio recordings and/or transcripts will be mainly used for study staff training purposes. 
During the verbal consent participants can opt in or opt out of being recorded. For those who 
agree to be recorded, at each nurse call the nurse will obtain assent by asking the Veteran 
to confirm they agree to be recorded during the phone session. This assent will be captured 
on the recording. 
 
  Data will also be placed at the VA Informatics and Computing Interface (VINCI; 
http://vaww.vinci.med.va.gov/vincicentral/VINCIWorkspace.aspx). The VA Informatics 
and Computing Infrastructure is a partnership between the VA Office of Information 
Technology and the Veterans’ Health Administration Office of Research and 
Development.  Researchers and operations staff can use VINCI to access data and 
statistical analysis tools in a virtual working environment through a certified VHA 
network computer using the VA Intranet or Virtual Private Network (VPN).  
B. Data Retention Plan 
 Research records will be maintained and destroyed according to the National 
Archives and Records Administration, Records Schedule Number:  DAA-0015-2015-
0004. Records destruction, when authorized, will be accomplished using the then 
current requirements for the secure disposal of paper and electronic records.  Currently, 
destruction of research records (see DAA-0015-2015-0004, section 7.6 “Research 
Investigator Files” for materials included in research records) is scheduled for 6 years 
after the cut-off (the cut-off is the completion of the research project) and may be 
retained longer if required by other federal agencies.  Records will not be destroyed 
without pre-notification to the facility records manager.   
  Other data retention plan, describe:        
 
 

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5. Data Access and Data Recipients 
Only members of our DVAMC research team will have access to identifiers and coded 
data that is located behind the VA firewall on our local server (see address above) and 
on the VINCI server. Coded data with direct identifiers removed (i.e., name, address, 
telephone numbers, SSN, DOB) will be placed at VINCI for the purpose of analysis. 
With the exception of Dr. King only coded data will be shared with Co-Investigators and 
the Scientific Advisory Board. 
 
All VA research personnel who have access to VHA records are instructed, in 
accordance with VA policy, on the requirements of Federal privacy and information laws 
and regulations, VA regulations and policies, and VHA policy. All study personnel who 
are VA employees working within the VA system have fulfilled all required HIPAA and 
other VA security and privacy policy training requirements and have agreed to follow 
guidelines pertaining to the protection of patient data.  All research staff sign VA Rules 
of Behavior, and all study staff are up to date with VHA Privacy Policy Training and the 
VA Office of Cyber and Information Security Awareness Training Course. The data 
security and privacy procedures summarized in that course include logging off or 
locking the computer when walking away from it; no sharing of access codes, verify 
codes or passwords; not allowing anyone else to use the computer under one’s 
password; and disposing of sensitive information using VA-approved methods (e.g., 
shredder bins). Access to study data will be removed for all study personnel when they 
are no longer part of the research team. 
 
6. Data and/or Specimen Transportation and/or Transmission for all data and/or 
specimens involved in the study:   
 
I. 
  Data and/or specimens will not be transported or transmitted outside of 
Durham VAMC environment. 
II. 
  Data and/or specimens will be transported BETWEEN sites that are under 
the auspices of the Durham VA Medical Center.   
III. 
   Data and/or specimens will be transmitted to other VA sites using the 
following method(s): 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted disk (encryption is optional). 
  Data are coded or contain identifiers and thus will be sent  
 Other, describe:  Limited amount of PHI (such as task lists with study IDs) will be 
transported outside of the Durham VAMC environment. Those staff who will transport 
any PHI will complete a VASI form. Staff work in office and remotely with VA laptops. 
Electronic study data and information are retained within the VA environment.  

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B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier 
(tracking is optional). 
  Specimens are coded or contain identifiers and thus will be sent via VA-
authorized carrier with tracking.   
  Other, describe:        
IV. 
  Data and/or specimens will be transported to non-VA/VHA sites (e.g., 
academic affiliates, laboratories, etc.) using the following method(s): 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted CD. 
  Data are coded or contain identifiers and thus will be sent via <chose 
method of transfer such as FIPS 140-2 encrypted CD or FIPS 140-2 
encrypted hard drive/flash drive> using VA—approved carrier with tracking.   
  Data are coded or identified and will be uploaded to sponsor website 
using electronic case report form (eCRF) <insert information including 
sponsor name and URL and the encryption the site uses.> 
 Other, describe:       
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier 
(tracking is optional) or will be hand-delivered by research study personnel.  
Specify method of delivery:        
  Specimens are coded and thus will be sent via VA-approved carrier with 
tracking or will be hand-delivered by research study personnel.  Specify 
method of delivery:        
In accordance with the HIPAA and the Privacy Act, for any coded or identifiable data or 
specimens released from the Durham VAMC (with the exception of Limited Data Sets), 
an Accounting of Disclosure (AOD) will be maintained (e.g., in a database or 
spreadsheet) that includes the participant’s name, date of the disclosure, description of 
the nature of the Individually Identifiable Information (III) disclosed, purpose of each 
disclosure, and the name and address of the person/agency to whom the disclosure 
was made. 
C.      
 Local DVAMC memorandum “Authorization to Use, Process, Store, or 
Transmit VA Sensitive Information Outside VA Owned or Managed Facilities” has 

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been pre-filled out for each study team member who may transport the data 
and/or specimens off-site.  These forms are included with the IRB materials.   
D.  
 
 
 Containers (e.g., briefcase, bin) are labeled with the following notice (label 
placed on the outside of container) in accordance with VHA Directive 6609: 
NOTICE!!! 
Access to these records is limited to: AUTHORIZED PERSONS ONLY. 
Information may not be disclosed from this file unless permitted by all applicable 
legal authorities, which may include the Privacy Act; 38 U.S.C. §§ 5701, 5705, 
7332; the Health Insurance Portability and Accountability Act; and regulations 
implementing those provisions, at 38 C.F.R. §§ 1.460 – 1.599 and 45 C.F.R. 
Parts 160 and 164. Anyone who discloses information in violation of the above 
provisions may subject to civil and criminal penalties. 
 
 
7. Risk Mitigation Strategies:   
  Data are fully de-identified (stripped of HIPAA 18 and study ID/code) before being 
shared outside of Durham VAMC. 
  Specimens are fully de-identified (stripped of HIPAA 18 and study ID/code before 
being shared outside of Durham VAMC. 
  Direct identifiers will be maintained separately from data and or specimens by using 
a code to “identify” subjects.  In a separate database (i.e., a “linking” or “cross-walk” 
database) this code will be linked to identifying subject information.    
To mitigate the risk of unauthorized access, data will be stored behind the VA firewall 
with password protected access. The PI, individuals study coordinators and statistician 
will bear responsibility for overseeing the privacy and security of the data.  
  Other, specify:        
8. Suspected Loss of VA Information: 
Should any incident such as theft or loss of data, unauthorized access of sensitive data 
or non-compliance with security controls occur it will be immediately reported according 
to VA policy. All incidents regarding information security/privacy incidents will be 
reported to the ISO and PO within 1 hour of acknowledgement of issue and done so 
using the VHADUR Research Events Report e-mail group 
(VHADURResearchEventReport@va.gov). 
 
 
9. Reporting of Results:   

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  Reporting of results, such as in scientific papers and presentations, will never 
identify individual subjects. For the quantitative aspects of the trial, Data will be presented 
in aggregate and individual-level data will not be published 
In order for this research to have an impact, stakeholders, and those in position to effect 
change based on study findings, will be informed of the study findings. We also 
anticipate presenting the findings of this study at professional conferences with a focus 
on Sleep. The annual meetings for the following professional organizations are likely 
venues for these presentations: the HSR&D Annual Meeting; and the annual meetings 
of the American Academy of Sleep Medicine. Further, we are likely to produce several 
manuscripts describing the outcomes of the study. We expect manuscript preparation to 
begin following completion of the study. 
  Other results reporting plan, describe:       
10. Future Use of Data: 
  Data will be retained for future use.  This is described elsewhere in the protocol and 
is noted in the HIPAA authorization. 
 
  Future Use of data is optional (i.e., not required by the research subject). 
  Future Use of data is required for participation in the study. 
  No future use of data is currently planned. 
11. Use of Mail Merge Technology 
  Mail merge programs will be used to generate letters and/or address labels for 
mailings to potential or already enrolled research subjects.  The study team is aware 
that to reduce risk of mail merge related privacy incidents, use of mail merge programs 
requires a 25% accuracy check to verify that (potential) research subject name and 
mailing address are properly “matched”.  If discrepancies are found, a 100% accuracy 
check is required before letters may be mailed.   
12. Use of Non-Standard Software 
 I do NOT intend to use any new specialized software (i.e., Software that’s not 
already approved OR installed) in this study. 
 
 I intend to use specialized software that has not already been installed and it has 
been approved for use by the VA Technical Reference Model (TRM) Group.  
(Note: All new software must be approved by TRM before it can be installed on VA 
systems.) 
 
 I intend to use previously installed software on my VA computer.  
 
13. Use of Cloud Computing Services 

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 Cloud computing services will NOT be used in this study. 
 
 Cloud computing services WILL be used in this study as described below and have 
been approved nationally by the VA Chief Information Officer (CIO).  (Note: ONLY cloud 
computing services that have been approved nationally may be used.) 
 
 
 
 

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