Implementation of Brief Insomnia Treatments - Clinical Trial
Phase: NA
Conditions: Chronic Insomnia
Sponsor: VA Pittsburgh Healthcare System

Protocol and Statistical Analysis Plan 
 
Implementation of Brief Insomnia Treatments - Clinical Trial (NCT02724800) 
PI: Adam Bramoweth, PhD 
 
IRB Initial Approval:  
 
3/11/2016 
Amendments: 
1 
Approved 
3/29/2016 
2 
Approved 
5/31/2016 
3 
Approved 
11/3/2016 
4 
Approved 
11/21/2016 
5 
Withdrawn 
1/6/2017 
6 
Approved 
1/9/2017 
7 
Approved 
2/7/2017 
8 
Approved 
3/14/2017 
9 
Approved 
5/22/2017 
10 
Approved 
9/18/2017 
11 
Approved 
10/18/2017 
12 
Approved 
2/27/2018 
13 
Approved 
3/27/2018 
14 
Approved 
5/16/2018 
15 
Approved 
7/3/2018 
16 
Approved 
7/9/2018 
17 
Approved 
7/31/2018 
18 
Approved 
9/17/2018 
19 
Approved 
2/8/2019 
20 
Approved 
7/26/2019 
Continuing Reviews: 
2016 
 
 
12/16/2016 
2017 
 
 
10/19/2017 
2018 
 
 
10/24/2018 
2019 
 
 
7/29/2019 
 
 
 
 

Objective 
The goal of this study is to test the non-inferiority of Brief Behavioral Treatment for Insomnia (BBTI) 
versus the current gold standard treatment for insomnia, Cognitive Behavioral Therapy for Insomnia 
(CBTI). 
 
Design 
This study is a prospective non-inferiority randomized clinical trial.  
Hypotheses 
1. Both BBTI and CBTI will significantly reduce insomnia symptoms, per the Insomnia Severity Index 
(ISI), from pre- to post-treatment. 
2. BBTI will be non-inferior to CBTI based on ISI change score from pre- to post-treatment.  
 
Methodology 
Participants 
Veterans with chronic insomnia were recruited. Eligible Veterans were ≥18 years, met Diagnostic and 
Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for insomnia disorder (First, Williams, 
Karg, & Spitzer, 2015), and had an ISI ≥15 (Bastien, Vallieres, & Morin, 2001).  
Veterans were excluded if they had: current or past bipolar, psychotic, or seizure disorder; alcohol use 
disorder or substance use disorder in the past six months; other current, severe, and unstable and/or 
untreated psychiatric and/or medical disorders; been hospitalized, for any reason, in the past month; 
untreated sleep apnea and/or other untreated non-insomnia sleep disorders; moderate to severe 
cognitive impairment; homeless or unstable housing; shift workers; or if female, were pregnant.  
This study was designed to enroll Veterans who would typically be eligible to engage in CBTI at a VAMC 
and was similar to the guidelines as part of the VA CBTI training program (Manber et al., 2014). 
 
Procedures 
All study procedures took place at VA Pittsburgh Healthcare System (VAPHS); recruitment, treatment, 
post-treatment, and 3-month follow-up took place May 2016 through June 2019, with 12-month follow-
up through March 2020. Participants were recruited with advertisements, by invitation from practicing 
insomnia providers, and with postings on Craigslist.com.  
Eligible Veterans, after a brief phone or in-person screen, were invited for an in-person appointment to 
sign informed consent and complete diagnostic interviews and self-report measures. Assessment of 
insomnia and other sleep disorders was conducted using the South Texas Research Organizational 
Network Guiding Studies on Trauma and Resilience (STRONG STAR) Clinical Interview for DSM-5 Sleep-
Wake Disorders (Taylor et al., 2018). Risk for obstructive sleep apnea (OSA) was assessed using the 
STOP-BANG questionnaire (Chung et al., 2012); Veterans scoring ≥5 and/or had untreated OSA were 
excluded and referred to the Sleep Medicine Clinic. Cognitive impairment was assessed using the St. 
Louis University Mental Status Examination (SLUMS; Tariq, Tumosa, Chibnall, Perry 3rd, & Morley, 
2006); Veterans with scores ≤20, indicative of serious cognitive impairment, were excluded. Finally, 

psychiatric disorders were assessed using the Structured Clinical Interview for DSM-5, Research Version 
(SCID-5-RV; First et al., 2015).  
 
Randomization and Sample Size 
Veterans were randomized to BBTI or CBTI in a 1:1 manner, in random block sizes of 2, 4, or 6, stratified 
by age (18-64 or ≥65) and use of a prescription sedative-hypnotic medication (yes or no). Sequentially 
numbered envelopes were used to assign participants based on their strata with concealment until 
randomization. Participants were enrolled by the Principal Investigator with the randomization strategy 
developed by the study statistician using Stata v14 and group assignment by the study coordinator.  
Sample size was calculated based on non-inferiority methods (Julious, 2004) and was further informed 
by the calculation of a non-inferiority margin (NIM), the pre-specified difference between treatments 
that demonstrates BBTI is not unacceptably worse than CBTI (Schumi & Wittes, 2011). The Reliable 
Change Index (RCI; Jacobson & Truax, 1991; Sloan, Marx, Lee, & Resick, 2018) measures change at post-
treatment not due to error, and for this study was calculated for the “control” condition (CBTI) using VA 
rollout data (Trockel et al., 2014). The RCI equation uses a measure of reliability (internal consistency or 
test-retest reliability) for the outcome measure, in this case the ISI. The RCI for CBTI was calculated using 
both reliability metrics to create a range of NIMs. Using Cronbach’s alpha (α=0.905; Morin, Belleville, 
Belanger, & Ivers, 2011) the RCI was 5.21 and using the test-retest reliability (r=0.78; Savard, Savard, 
Simard, & Ivers, 2005) the RCI was 3.43. We chose the NIM of 3.43. Accounting for 25% attrition, based 
on prior CBTI and BBTI studies (Buysse et al., 2011; Germain et al., 2014; Trockel et al., 2014) the target 
randomization goal was 56 participants (n=28/group) with 42 (n=21/group) completing post-treatment 
assessment to achieve 80% power. 
 
Clinician Training 
Study clinicians attended a half-day training by the Principal Investigator and study Co-Investigator; CBTI 
and BBTI trainings were separate and study clinicians only received one training. CBTI (Manber et al., 
2014) was delivered in 5 in-person sessions, weekly or bi-weekly, with a goal of completing treatment in 
8 weeks. The components included psychoeducation, sleep health education, stimulus control, sleep 
restriction, cognitive restructuring of maladaptive beliefs, and relaxation strategies as needed. Sleep 
diaries were completed daily throughout treatment, beginning with the baseline assessment. Increasing 
prescribed time in bed (TIB) occurred if sleep efficiency (SE) was ≥85%, in which case TIB was increased 
15 minutes (if wanted by participant). CBTI was delivered by two licensed psychologists, one who 
delivered care in the Mental Health Clinic and another in Primary Care.  
 
Interventions 
BBTI (Troxel et al., 2012) includes one to two in-person sessions (session 1 and 3; week 3 is optional by 
phone) and two phone sessions (sessions 2 and 4) and will occur within 5 weeks. 
▪ 
Session 1 (45 minutes, in person). Background information is provided about healthy sleep practices 
and the mechanisms of sleep regulation as well as the principles of stimulus control, sleep 
restriction, and sleep hygiene. Baseline sleep diaries will determine initial sleep parameters (e.g., 
bedtime, wake time, sleep onset latency, sleep efficiency). Lastly, the four “rules” are introduced 
and discussed. 

▪ 
Reduce your time in bed. Sleep diaries will determine the prescribed bedtime, with the goal 
to match time in bed to time asleep (plus an additional 30 minutes to account for a normal 
amount of time spent awake at night). Reducing time in bed helps to increase the 
homeostatic sleep drive. 
▪ 
Wake up at the same time every day. A consistent wake time is a) the most important cue 
for setting the biological clock, b) regulates exposure to morning light (another cue for the 
biological clock), and c) helps to increase the homeostatic sleep drive. 
▪ 
Do not go to bed unless sleepy. By waiting until the sleep drive is at its peak, the likelihood of 
falling asleep is increased. The key is helping the Veteran understand the difference 
between sleepiness and fatigue/tiredness. The bedtime is restricted by the prescribed 
bedtime set by the sleep diaries as well as a state of sleepiness. Bedtime is not determined 
by when the Veteran “should” go to sleep. 
▪ 
Do not stay in bed unless asleep. By saving the bed for sleep and sexual activity only, the 
association between the bed and sleep is strengthened. Staying in bed while awake 
perpetuates the cycle of wakefulness→frustration→arousal→wakefulness. This cycle is 
broken by staying out of bed if awake. The recommendation is to get out of bed if awake for 
longer than 30 minutes (self-estimation). 
▪ 
Session 2 (<20 minutes, phone call). This is a check-in regarding changes in sleep/wake behaviors 
implemented in session 1. The clinician and Veteran will discuss the sleep diary from the past week, 
discuss adherence to the “rules,” and problem-solve any adherence issues. 
▪ 
Session 3 (<30 minutes, in person or by phone). The Veteran and clinician will review the past two 
weeks of sleep diaries and adjust the sleep schedule as needed. If SOL and WASO are <30 minutes 
for most nights during the previous two weeks, the Veteran can extend their sleep schedule by 15 
minutes, either advancing the bedtime or delaying the wake time. If SOL/WASO is >30 minutes for 
most nights, sleep schedule is restricted by 15 minutes. Adherence to treatment recommendations 
is reinforced. 
▪ 
Session 4 (<20 minutes, phone call). The final session, a phone call, addresses treatment difficulties, 
reviews the progress made, and covers relapse-prevention techniques. The concepts of stimulus 
control and sleep restriction are emphasized, as is the process of titrating sleep using the 30/30 rule. 
 
CBTI (Manber et al., 2014) consists of five sessions, about 45-minutes each, and will occur within an 8-
week period. 
▪ 
Session 1. Basic sleep education, including a review of the predisposing, precipitating, and 
perpetuating factors of insomnia (3P model of insomnia). The homeostatic sleep drive and circadian 
drive are explained. Next, stimulus control, sleep restriction, and sleep hygiene are reviewed; these 
concepts provide the basic structure to improve insomnia. 
▪ 
Wake-up and get out of bed at the same time every day. A consistent wake time is a) the 
most important cue for setting the biological clock, b) regulates exposure to morning light, 
and c) helps to increase the homeostatic sleep drive for subsequent nights. 
▪ 
Go to bed when you are sleepy, but not before a prescribed bedtime. By waiting until the 
sleep drive is at its peak, the likelihood of falling asleep is increased. 

▪ 
Get up when you can’t sleep. Staying in bed while awake perpetuates the cycle of 
wakefulness à frustration à arousal à wakefulness. When unable to sleep, it is recommended 
to get out of bed and go to another room until sleepiness returns. 
▪ 
Use the bed only for sleeping. By saving the bed for sleep and sexual activity only, the 
association between the bed and sleep is strengthened. Avoid TV, reading, work, etc., while 
in bed. 
▪ 
Avoid daytime napping, particularly in the late afternoon or early evening. Sleep during the 
day can reduce the homeostatic sleep drive and make it more difficult to fall asleep at the 
desired bedtime. 
▪ 
Create a buffer zone. This is a quiet time prior to bedtime that can help to reduce stress. It 
provides a transition between the goal-oriented activities of the day and the quiet more 
peaceful time of sleep. 
▪ 
Don’t worry, plan, etc., in bed. Avoid any stressful, worrisome, or stimulating activities in 
bed. Preoccupation with worries, problems, or planning can increase arousal and interfere 
with sleep. 
▪ 
Other helpful practices/sleep hygiene. Recommendations include: turn the clock around, 
limit caffeine in the afternoon, limit alcohol within 3 hours of bedtime, exercise regularly but 
not close to bedtime, keep bedroom quiet, dark, and cool, avoid heavy meals close to 
bedtime but don’t go to bed hungry. 
▪ 
Session 2. Sleep diaries are reviewed, and prescribed bedtime is titrated based on sleep efficiency. If 
sleep efficiency <80%, time in bed is reduced by 15 minutes. If sleep efficiency ≥85%, time in bed is 
increased by 15 minutes. Problem-solving and motivational enhancement is used for any adherence 
issues. Additional handouts include information on what to do when awake (night and morning), 
enjoying your morning, and reasons for feeling tired. 
▪ 
Session 3-4. Sessions 3 and 4 are focused on continued titration of the sleep schedule, monitoring 
adherence to treatment guidelines (1-8 above), and identifying and challenging dysfunctional beliefs 
about sleep (DBAS questionnaire), such as: “I need 8 hours of sleep per night” or “Insomnia has 
serious health consequences.” Identifying and challenging automatic thoughts about sleep is can 
also be helpful. Lastly, relaxation (active or passive) may be introduced and practiced. 
▪ 
Session 5. Continue titrating time in bed, cognitive restructuring, and relaxation as needed. If 
improvements have been appropriate, session 5 may focus on relapse prevention, summarizing 
gains, and discussing what was, or was not, helpful. Elements of relapse prevention include: keep a 
consistent wake time; go to bed only when sleepy, but not before the regular bedtime; and get out 
of bed if unable to sleep. 
  
Measures 
The primary outcome measure was the ISI (Bastien et al., 2001), administered at baseline, in-person 
treatment sessions, one-week post-treatment, and the 3-month and 12-month follow-up assessments.  
The Consensus Sleep Diary (Carney et al., 2012) was used to collect data on sleep behaviors, including 
bedtimes, rise times, sleep onset latency (SOL), nighttime awakenings (NWAK), wake after sleep onset 
(WASO), time in bed (TIB), total sleep time (TST), total wake time (TWT), sleep efficiency (SE), and sleep 

quality (SQ). Diaries were administered for two weeks of baseline, during treatment, two weeks after 
the post-treatment assessment, and the 3-month and 12-month assessments.  
Additional sleep measures administered at baseline, post-treatment, 3-month and 12-month 
assessments included the Pittsburgh Sleep Quality Index (PSQI; Buysse, Reynolds, Monk, Berman, & 
Kupfer, 1989) as a measure of sleep quality, the Dysfunctional Beliefs and Attitudes about Sleep scale 
(DBAS; Morin, Vallieres, & Ivers, 2007) to assess sleep-disruptive cognitions, and the Epworth Sleepiness 
Scale (ESS; Johns, 1991) to assess daytime sleepiness.  
Self-report measures of psychiatric symptoms included the Patient Health Questionnaire 9 (PHQ9; 
Kroenke, Spitzer, & Williams, 2001) to assess depression, the Generalized Anxiety Disorder 7 (GAD7; 
Spitzer, Kroenke, Williams, & Lowe, 2006) to assess anxiety, and the PTSD Checklist for DSM-5 (PCL5; 
Blevins, Weathers, Davis, Witte, & Domino, 2015) to assess symptoms of PTSD. Additional measures 
included the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Scale 
(Reeve et al., 2007) to assess fatigue and its impact on functioning and quality of life, a brief pain scale 
measuring pain intensity (P), interference with enjoyment of life (E), and interference with general 
activity (G [PEG]; Krebs et al., 2009), the PROMIS Global Health Scale (Hays, Bjorner, Revicki, Spritzer, & 
Cella, 2009) to measure the impact of physical health (QOL-PH) and mental health (QOL-MH) on quality 
of life, the Work and Social Adjustment Scale (WSAS; Mundt, Marks, Shear, & Greist, 2002) to measure 
psychosocial functioning impairment due to insomnia, and the Patient Global Impression of Change 
(PGIC; Hurst & Bolton, 2004). Psychiatric symptom and psychosocial measures were administered at 
baseline, post-treatment, and 3-month and 12-month assessments.  
 
Summary of self-report measures 
Measure 
Items 
Score Range 
Desired Direction 
ISI 
7 
0-28 
↓ 
PSQI 
18 
0-21 
↓ 
ESS 
8 
0-24 
↓ 
DBAS║ 
16 
0-10 
↓ 
PHQ9‡ 
8 
0-24 
↓ 
GAD7 
7 
0-21 
↓ 
PCL5‡ 
19 
0-76 
↓ 
Fatigue† 
6 
33.4-76.8 
↓ 
PEG 
3 
0-30 
↓ 
QOL-PH† 
4 
16.2-67.7 
↑ 
QOL-MH† 
4 
21.2-67.6 
↑ 
WSAS 
5 
0-40 
↓ 
PGIC 
7 
1-7 
↑ 
Notes: ║ average score; ‡ sleep item removed; † T scores 
ISI, Insomnia Severity Index; PSQI, Pittsburgh Sleep Quality Index; ESS, Epworth Sleepiness Scale; 
DBAS, Dysfunctional Beliefs and Attitudes about Sleep; PHQ9, Patient Health Questionnaire; GAD7, 
Generalized Anxiety Disorder; PCL5, Posttraumatic Stress Disorder Checklist; PEG, pain intensity, 
interference with enjoyment of life, and interference with general activity; QOL-PH, Quality of Life – 
Physical Health; QOL-MH, Quality of Life – Mental Health; WSAS, Work and Social Adjustment Scale; 
PGIC, Patient Global Impression of Change. 
 
 

Statistical Analysis Plan 
Analyses were conducted with STATA v14. Baseline differences between CBTI and BBTI were analyzed 
using chi-square tests and t-tests.  
To test treatment effectiveness, an intent-to-treat (ITT, n=63) and per-protocol (PP, n=24) approach 
were used. Consistent with ITT, all individuals randomized, regardless of their completion status, were 
encouraged to complete the post-treatment and follow-up assessments.  
PP analyses were conducted on Veterans in each group that met strict criteria—attending all treatment 
sessions within the time frame defined a priori (BBTI: n=12, 4 sessions in 5 weeks; CBTI: n=12, 5 sessions 
in 8 weeks) and completing the one-week post-treatment assessment. 
Linear mixed models (LMM) were used to test the main effects of treatment (CBTI vs. BBTI), time 
(baseline vs. post-treatment), and the interaction of treatment X time. Effect sizes were computed using 
Glass’s Δ (|Mpre – Mpost|/SDpre; Morris, 2008).  
Treatment response was an ISI reduction at post-treatment of ≥8 points (indicating a moderate 
response), and remission was a treatment response plus an ISI score ≤7 at post-treatment (indicating no 
clinically significant insomnia symptoms; Morin et al., 2011).  
To establish BBTI as non-inferior to CBTI, the upper bound of the 95% confidence interval of the mean 
ΔISI from pre- to post-treatment (ΔISICBTI – ΔISIBBTI) cannot exceed the NIM of 3.43. If the upper bound of 
the confidence interval exceeds the NIM, non-inferiority cannot be declared (inconclusive). If the lower 
bound of the confidence interval exceeds the NIM, BBTI will be declared inferior to CBTI. However, 
should the upper bound of the confidence interval not exceed zero, BBTI will be declared superior to 
CBTI (Aberegg, Hersh, & Samore, 2018).  
 
 
 
 
 
 
 
 

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