Characterization of Sleep With Trauma Nightmares Using Ambulatory Sleep Measurement
Phase: NA
Conditions: Nightmares, Stress Disorders, Post-Traumatic, Actigraphy, Respiratory Sinus Arrhythmia, Veterans
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
IRB# 1749294  
Title: Characterization of sleep with trauma nightmares using ambulatory sleep measurement 
Funding Agency: VA Clinical Science Research & Development 
Principal Investigator/Study Chair: Katherine E. Miller, PhD, DBSM 
Version 2. June 06, 2023 
 
 
 
 

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Abstract 
 
Objectives: This project has two primary aims: (1) to identify, with greater precision than 
previously possible, physiological parameters of sleep associated with trauma-related 
nightmares, employing one week of ambulatory mattress actigraphy and one night of minimal 
polysomnography assessment in Veterans’ homes; and  (2) to employ treatment for nightmares 
as interventional probes to determine whether changes in sleep physiological parameters 
covary with changes in subjective nightmare frequency and severity.  
Design: This will be a prospective, longitudinal study using a multi-method assessment 
approach of sleep disturbances with trauma-exposed Veterans. We will account for 20% loss 
during study period. Therefore, we will aim to recruit 96 individuals, with the goal of randomizing 
80 individuals for the treatment phase of the study. At the MVAHCS, we anticipate recruiting 
and enrolling 57 Veterans, with the goal of randomizing 41 individuals for the treatment phase of 
the study. Participation will occur in two phases. First, all initially eligible participants will 
complete one week of at-home sleep monitoring with a mattress actigraphy system, with event 
marking capability that can be activated by participants upon waking from a nightmare. During 
that week, participants will also complete one-night of home polysomnography sleep 
assessment to record sleep stage measures and patterns of arousals. Participants will be 
randomized to the receive active psychotherapy (Exposure, Relaxation, and Rescripting 
Therapy; ERRT) or to the comparison control psychotherapy (sleep and nightmare 
management). Treatment will occur once per week for 5 weeks. Participants will continue to 
sleep while monitored by the mattress actigraphy system during treatment and will complete 
assessments one week and three months following the end of treatment.   
Significance: It is expected that results from this study will provide important information to 
facilitate increased understanding of the phenomenology, pathophysiology, and treatment of 
nightmares in trauma-exposed Veterans. 
 

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List of Abbreviations 
AHI 
Apnea Hypopnea Index 
ANCOVA 
Analysis of Covariance  
ANOVA 
Analysis of Variance  
CAPS-5 
Clinician-Administered PTSD Scale  
CBOC 
Community Based Outpatient Clinics 
CPRS 
Computerized Patient Record System  
CSR&D 
Clinical Science Research & Development 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
DMC 
Data Monitoring Committee  
DSI-SS 
Depressive Symptom Index: Suicidality Subscale  
DSM-5 
Diagnostic and Statistical Manual of Mental Disorders-5 
EBT 
Evidence-Based Treatment 
ECG 
Electrocardiogram 
EEG 
Electroencephalography 
EMG 
Electromyogram 
EOG 
Electroculogram 
ERRT 
Exposure, Relaxation, and Rescripting Therapy  
FoSI-SF 
Fear of Sleep Inventory-Short Form 
GLMM 
Generalized Linear Mixed Modeling 
HRV 
Heart Rate Variability 
Hz 
Hertz 
MEM 
Micro-electro-mechanical 
MHB 
Mental Health and Behavioral Science  
MINI 
Mini International Neuropsychiatric Interview 
MVAHCS 
Minneapolis VA Health Care System  
NDI 
Nightmare Disorder Index 
NES 
Nightmare Effects Survey 
PCL 
PTSD Checklist  
PHQ-9 
Patient Health Questionnaire  
PI 
Principal Investigator  
PMI 
Prescription Medication Index 
PSG 
Polysomnography 
PSQI 
Pittsburgh Sleep Quality Index 
PSQI-A 
Pittsburgh Sleep Quality Index-Addendum 
PTSD 
Posttraumatic Stress Disorder 
RCT 
Randomized Controlled Trial 
REDCap 
Research Electronic Data Capture 
REM 
Rapid Eye Movement 
RSA 
Respiratory Sinus Arrhythmia  
SNRI 
Serotonin and Norepinephrine Reuptake Inhibitor 
SpO2 
Oxygen Saturation 
SRG 
Scientific Review Group 

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SSRI 
Serotonin Selection Reuptake Inhibitor  
TRNS 
Trauma-Related Nightmare Survey 
VINCI 
VA Informatics and Computing Infrastructure 
 
 
 

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Contents 
Protocol Title:  Characterization of sleep with trauma nightmares using ambulatory sleep 
measurement. ............................................................................................................................ 6 
1.0 
Study Personnel .............................................................................................................. 6 
2.0 
Introduction ..................................................................................................................... 6 
3.0 
Objectives ....................................................................................................................... 8 
4.0 
Resources and Personnel ............................................................................................... 8 
5.0 
Study Procedures ............................................................................................................ 9 
5.1 Study Design .................................................................................................................... 9 
5.2 Recruitment Methods.......................................................................................................17 
5.3 
Informed Consent Procedures ....................................................................................18 
5.4 Inclusion/Exclusion Criteria ..............................................................................................19 
5.5 Study Evaluations ............................................................................................................19 
5.6 Data Analysis ..................................................................................................................24 
5.7 Withdrawal of Subjects ....................................................................................................25 
6 
Reporting ...........................................................................................................................25 
7 
Privacy and Confidentiality .................................................................................................25 
8 
Communication Plan ..........................................................................................................26 
9 
References ........................................................................................................................26 
 
 
 

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Protocol Title:  Characterization of sleep with trauma nightmares using ambulatory sleep 
measurement.  
 
1.0 
Study Personnel 
 
• 
Principal Investigators/Study Chairs:  
o Katherine E. Miller, PhD 
▪ 
612-467-3894 
▪ 
Minneapolis VA Health Care System  
▪ 
Licensed Psychologist (CA license), credentialed, board certified in 
Behavioral Sleep Medicine  
▪ 
VA Employee – full time 8/8ths  
• 
Co-Investigators: None  
• 
Collaborators: 
o Philip Gehrman, PhD 
▪ 
Michael J. Crescenz VA Medical Center, Philadelphia, PA  
▪ 
Licensed Psychologist 
▪ 
VA employee 
▪ 
Serves as primary mentor on this career development award.  
o Steve Woodward, PhD 
▪ 
National Center for PTSD, VA Palo Alto Health Care System, Palo Alto, 
CA 
▪ 
Licensed Psychologist  
▪ 
VA employee  
▪ 
Serves as secondary mentor on this career development award.  
o Richard Ross, MD, PhD 
▪ 
Emeritus at Michael J. Crescenz VA Medical Center, Philadelphia, PA 
▪ 
Physician  
▪ 
VA WOC 
▪ 
Serves as secondary mentor on this career development award.  
• 
Study Coordinator: TBD, in process of hiring 
 
• 
No additional participating sites.  
2.0 
Introduction 
• 
Scientific background and rationale: Nearly 90% of Veterans diagnosed with 
posttraumatic stress disorder will report clinically significant sleep complaints, 
including insomnia and nightmares [1,2]. Added to the impact of PTSD, trauma-
related nightmares have a significant negative effect on several domains of 
functioning, including perception of health, maintenance of employment, and 
suicidal behavior [4-6]. Due to the potential chronicity of nightmares, their 
cumulative impact on health domains, and their unique association with suicidal 

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behavior, there is a critical need for continued research to better understand this 
phenomenon with the goal of developing personalized treatment plans. In spite of 
an urgent need, the underlying mechanisms of trauma-related nightmares are 
poorly understood, and there are no unequivocally evidence-based treatments 
[7]. Limitations of current assessment procedures present a significant barrier to 
improved care.  
The high rates of sleep disturbances in Veterans treated in the VHA are being 
addressed with the dissemination of cognitive-behavioral therapy for insomnia 
(CBT-I). Currently, CBT-I is the only recommended psychotherapy approach for 
sleep disturbances among PTSD-diagnosed Veterans. No clear 
recommendations have been provided regarding psychotherapeutic and 
pharmacological approaches for trauma-related nightmare treatment due to 
inconsistent evidence of their efficacy. Thus, there is significant room for 
improvement in the treatment of trauma-related nightmares. In this study, we will 
be randomizing subjects to two types of therapies that are used clinically at our 
VA with some modifications. We offer cognitive-behavioral therapy for 
nightmares, including Exposure Relaxation, and Rescripting Therapy (ERRT), in 
clinic. The sleep and nightmare management (control group) is similar to ERRT; 
however, we have taken out of that treatment what we believe to be “active” 
components (i.e., exposure to nightmare content, rescripting the content, and 
additional relaxation strategies). Therefore, the control group is similar to 
cognitive-behavioral therapy for insomnia and components of this treatment are 
also offered in clinic. A previous trial of similar nightmare treatments found that 
this control treatment was still beneficial for reducing nightmare frequency 
despite not containing the “active” ingredients.  
• 
Gaps in current knowledge: In-laboratory sleep studies rarely capture 
nightmares, limiting our knowledge of phenotypic biomarkers to guide treatment. 
Additionally, conventional sleep studies, typically carried out over one or two 
nights, cannot assess physiological variables related to the response to 
nightmare treatments. Therefore, it is critical to assess sleep over multiple nights 
in the home environment, where nightmares occur. Such an approach will refine 
the detection of physiological variables associated with nightmares, and changes 
in these variables across the course of treatment. This project addresses these 
methodological shortcomings by employing zero-burden, multi-night, objective 
sleep measurement in Veterans’ usual sleeping environment, prior to and during 
an evidence-based cognitive-behavioral intervention for nightmares, Exposure, 
Relaxation, and Rescripting Therapy (ERRT) [8]. This project is positioned to 
advance the knowledge of the trauma-related nightmare field in these important 
ways: 
o In-home, low-burden objective assessment during sleep in Veterans 
reporting chronic nightmares will allow us to identify, with greater 
precision than previously possible, objective features of trauma-related 
nightmares.  
o No other published study examining the efficacy of a nightmare 
intervention has used objective sleep measurement through the treatment 
period. Findings from the proposed study could provide a clinically 
meaningful measurement of nightmare treatment response or non-
response.  

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o The use of treatment as a probe to evaluate the longitudinal changes in 
nighttime physiology with trauma-related nightmare reports also provides 
an ideal opportunity to explore the effects of treatment on increasing 
respiratory sinus arrhythmia, a potential mechanism of change. 
Therefore, results from this study can being to elucidate the physiological 
conditions that may influence efficacy of nightmare treatments.  
3.0 
Objectives 
• 
Aims:  
o Aim 1: To identify, with greater precision than previously possible, 
physiological parameters of sleep associated with trauma-related nightmares, 
employing one week of ambulatory mattress actigraphy and one night of 
minimal PSG assessment in Veterans’ homes (n = 80). 
o Aim 2: To validate the physiological parameters identified in Aim 1, a five-
week treatment for trauma-related nightmares (ERRT; n = 40) and a 
comparison control treatment (n = 40) will be employed as interventional 
probes to determine whether changes in sleep physiological parameters 
covary with changes in subjective nightmare frequency and severity. 
• 
Hypotheses:  
o Hypothesis 1.1: Nights with nightmare reports, compared to nights without 
nightmare reports, will be predicted by lower actigraphic sleep efficiency and 
lower sleep RSA. 
o Exploratory hypothesis 1.2: Within nights with nightmare reports, the 90-
minute time period directly preceding the onset of a nightmare, the latter 
signaled by the participant pressing an event button, will be marked by a 
decrease in sleep RSA. 
o Hypothesis 2.1: Veterans who receive ERRT, compared to those who receive 
a comparison control treatment, will evidence greater increases in actigraphic 
sleep efficiency and sleep RSA during the five-week treatment and through 
the one-week post-treatment follow-up assessment. 
• 
Results from this CDA-2 will increase understanding of trauma-related nightmare 
pathophysiology, and advance strategies for personalizing symptom management in 
Veterans. 
4.0 
Resources and Personnel 
• 
Primary Investigator – The PI will be directly responsible for all aspects of the 
research, including study design and implementation, development and execution of 
the study protocol, development of the hypotheses to be tested, research design, 
implementation, and monitoring, as well as presentation of the study results via 
publication and dissemination at scientific conferences. The PI will have access to 
PHI, be involved in recruitment, obtain informed consent, obtain clinical data, 
conduct mattress installation, and monitor data collection, conduct PSG 
administration, administer treatment protocols, supervise research staff, and conduct 
data analysis. 

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• 
Study Coordinator (to be hired) – The study coordinator will be hired. This individual 
will be responsible for the following: (1) participant recruitment and retention, (2) 
scheduling appointments, (3) conducting phone screening interviews, (4) data entry 
and processing, (5) participant tracking, and (6) maintaining records for the IRB. This 
individual will also assist in obtaining informed consent, documenting in charts, the 
administration of interviews, questionnaires, and the set-up and recording of 
objective sleep assessments. This individual will have access to PHI. 
• 
Research staff (To be determined) - This individual(s) will be recruited to assist with 
the execution of the study. S/he (or they) will have access to PHI and be involved 
primarily in the set-up and recording of objective sleep assessments. These 
individuals may also be trained to conduct assessments at the end of treatment. 
• 
Collaborators:  
o Philip Gehrman, PhD – Dr. Gehrman will serve as primary mentor on this 
career development award. This role will include oversight of the research 
plan, assist in inclusion/exclusion decisions, and serve as an on-site 
consultant for treatment questions. He will be involved in de-identified data 
analysis and preparation of manuscripts. 
o  Richard Ross, MD, PhD - Dr. Ross will also provide mentorship on this 
study, specifically providing consultation on the execution of the study design 
and inclusion/exclusion decisions. He will be involved in preparation of 
manuscripts. 
o Steve Woodward, PhD – Dr. Woodward will also provide mentorship on this 
study. His role will focus on any technical issues with the measurement 
devices, interpretation of the ambulatory measurement data, and the 
integration of research findings future research study. He will have access to 
de-identified data and be involved in data analysis. 
o Joanne Davis, PhD (consultant) – Dr. Davis is an expert in nightmare 
treatment and developed the treatment protocol outlined in this protocol. She 
will provide monthly clinical consultation. This consultation will not involve 
PHI; and instead focus on the content of the protocol.  
• 
There will be no contractors or applicable MOUs or DUAs.  
5.0 
Study Procedures 
5.1 Study Design 
• 
Study participation will occur in two parts to address the two aims of the 
study. First, a baseline eligibility screening visit will be conducted. Eligible 
participants will complete one week of at-home sleep monitoring with the 
mattress actigraphy system, with event marking capabilities that can be 
activated by participants upon waking from a nightmare. At the time of 
mattress installation, participants will also complete one night of home 
PSG sleep assessment to record sleep stage measures and patterns. If 
the PSG reveals that the participant likely has sleep apnea, they will be 
able to continue to participate but the research team will consult with a 
physician at the MVAHCS sleep center to place a referral to discuss 
follow-up and treatment options with the Veteran. Participants also will be 

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randomized to the active treatment (Exposure, Relaxation, and 
Rescripting Therapy; ERRT) or to the comparison control treatment 
(sleep and nightmare management). Participants will continue to sleep 
while monitored by the mattress actigraphy system during treatment and 
will complete assessments one week and three months following the end 
of treatment. The table below outlines the procedures for the active 
treatment and comparison groups.     
 
Week  
Baseline Assessment 
Treatment and Follow-up 
1 
2 
3 - 7 
8 
20 
Visit 
Screening 
Baseline Visit 
Baseline 
Sleep 
Monitoring 
Treatment 
Sessions 
Time 2 
Follow-up 
Assessment 
Time 3 
Follow-up 
Assessment 
Activity  
• Diagnostic 
Interviews  
• Self-Reports 
 
If eligible:  
• Receive 
Sleep/Nightmare 
Diary 
• Install Actigraphy 
Mattress (30 
mins.) 
• In-home PSG 
• Mattress 
collection 
for one 
week  
• Subjective 
sleep 
quality & 
nightmares 
on sleep 
diaries 
 
If eligible:  
• Randomized 
to ERRT or 
Sleep & 
Nightmare 
Management 
• Continue in-
home sleep 
monitoring 
• Diagnostic 
interviews 
• Self-reports  
• Continue in-
home sleep 
monitoring  
• Uninstall 
mattress at 
end of week 
(10 mins.) 
• Self-
reports 
 
Pre consent Phone Screen: After an introductory letter is sent to potential subjects, the 
study team will call the potential subject. Also, Veterans who are interested in the study 
after reviewing recruitment material (e.g., flyers, brochures) can contact the study 
number for a telephone screen. All interested individuals will be administered a brief 
telephone screen (see telephone script in the appendix) to assess their appropriateness 
for the study. Individuals reporting no exclusionary criteria will be scheduled for consent 
followed by a baseline evaluation. 
Post-consent Screening Baseline Evaluation Visit: Following initial telephone screening, 
Veterans will be invited to complete a baseline screening assessment either in-person or 
virtually. Before the baseline assessment, Veterans will provide written informed consent 
(and HIPAA authorization) in-person, or electronically through DocuSign. 
• 
If in-person, Veterans will present to the MVAHCS to provide informed written 
consent (with embedded HIPAA authorization) and to participate in a baseline 
screening assessment.  
• 
DocuSign - Veterans and study staff will electronically access the informed 
consent and HIPAA documents. For consenting, Veterans will receive the 
document, and access a virtual “room” via a videoconferencing platform to review 
the consent documents with study staff. Veterans will provide electronic consent 
and will have access to the signed document via the program. The signed 
consent document can be mailed to Veterans who prefer a paper copy.  

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Following the consent process, regardless of that procedure, Veterans will be screened 
for current sleep disturbances, PTSD symptoms, and exclusionary criteria with a 
diagnostic interview, interview- administered, and self-reported assessments. Veterans 
who meet eligibility criteria will be scheduled for a home visit to begin participation in the 
one week of sleep monitoring and one night of polysomnography. Participants who do 
not meet eligibility criteria from this baseline screening will be excluded from participation 
and referred for appropriate clinical care. 
Baseline: Sleep Monitoring: Prior to installation, an equipment loan agreement will be 
presented to the participants to indicate the participants will take responsibility for the 
equipment and agree to return the items to the research staff when arranged. This loan 
agreement is the same that issued in routine clinical practice within the sleep center. 
Equipment malfunctions and typical wear and tear are expected from this agreement. 
Study participation will not continue if the Veterans are unwilling to sign these 
agreements.  
Installation of mattress actigraphy system and one-night of an ambulatory PSG study: A 
home visit to the Veteran’s usual sleeping environment will be scheduled. Trained 
research staff will travel to the Veteran’s home to install the mattress actigraphy system 
and hard drive computer for data collection. The installation process takes approximately 
15 minutes. Participants also will undergo one-night of ambulatory PSG study concurrent 
with mattress actigraphy in the home to record sleep stage measures and patterns of 
arousals, and to calibrate sleep efficiency derived from the mattress system. The hook-
up process for the PSG takes approximately 30-45 minutes. The Veteran will also be 
provided instructions to complete a daily sleep and nightmare diary. Following the one 
night of PSG, the research staff will collect the PSG equipment. The Veterans will 
continue to sleep using the mattress actigraphy system and complete the sleep diary for 
a total of seven nights. Veterans determined to have moderate or severe apnea can still 
be randomized to treatment and participate in the study; however, they will also be 
referred for further evaluation through the sleep center.  
 
Info about the actigraphy system: Mattress actigraphy data will be collected 
through a program on a password-protected data collection device (mini-PC). Data 
collected from this system and stored within the mini-PC include: Participant’s IDs, 
dates, times, button presses, accelerometer data, per-30-second-epoch processed data 
(e.g., heart rate, respiration, number of movements), and an event record of individual 
movements, snores, bradycardias. No mental health, medical, demographic, or other 
patient identifying data are collected through this system. The way the data file is 
composed makes the data meaningless to anyone other than the research team.  
Following completion of the mattress-actigraphy data collection, all data backed-up on 
the mini-PC will be transferred to the secure research server within the study folder that 
only approved research staff can access. Data will be transferred from the hard drive to 
the secure network by using an approved VA-method. These devices will never be 
connected to a VA computer. Once transferred, data will be deleted from the PC. When 
not in use, these mini-PCs will be stored within the locked Bldg 68 office (211).  
Treatment: Cognitive behavioral therapy for nightmares, including ERRT, are offered 
within standard care. The sleep and nightmare management (control group) is like 
ERRT; however, it does not contain what we believe to be “active” components of the 
nightmare treatment (i.e., exposure to the nightmare content, rescripting the content and 
additional relaxation strategies). Therefore, the control group is more similar to cognitive 

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behavioral therapy for insomnia, another treatment offered in standard clinical care. The 
PI of this study will be providing treatment to participants. Additional credentialed 
psychologists or psychology-trainees (under supervision) may also serve as study 
therapists. In this case, an amendment with these details will be submitted for IRB 
approval.  
While the treatment sessions are similar to treatment received outside of the study, they 
are considered a research procedure since participants are randomized to these 
treatments.  
Randomization procedures: A simple randomization procedure will be used to randomize 
participants to the treatment groups in a 1:1 allocation ratio. This will be done using a 
random number generator. This method ensures complete randomness of the 
assignment of a participant to each group.  
Audio recording: Only with participants’ consent, in-person and virtual clinical interviews 
and treatment sessions will be audio-recorded for the purposes of training, and 
adherence to protocols. Subjects can decline and still participate in the study. These 
recordings will only use research code numbers. Recordings will be obtained using VA-
approved video/audio platforms. Recordings will be uploaded and stored securely on the 
research server. Participants will be asked each time and can decline the recording at 
any point. They can still participate without any negative consequences or loss of 
benefits. 
Follow-up Assessments: Upon completion of the treatment and sleep recording period, 
participants will complete a second in-person or virtual assessment with an assessor 
blind to group assignment (Time 2/post-treatment). Trained research staff will return to 
the Veteran’s home to uninstall the mattress actigraphy system. A three-month post-
treatment follow-up assessment also will be conducted with an assessor blind to group 
assignment (Time 2/follow-up assessment).  
• 
Risks: 
1. Risks associated with self-report questionnaires, clinical interviews, and treatment:  
a. Some participants may be hesitant to record their symptoms on assessment 
forms. 
b. The current study will involve asking participants to report any previous 
traumatic events in their lives and to describe their trauma-related nightmares 
in detail. Some participants may be uncomfortable describing their symptoms 
and trauma history to a mental health professional. While stress or discomfort 
is possible, research documents that exposure-based techniques are well 
tolerated and provide benefit. 
c. Participants may need to travel to the VA for the baseline assessment, 
treatment sessions, and post-treatment assessment, which may create 
inconvenience.   
2. Risks of randomization:  
a. Participants will be randomized to one of two treatments with a 50/50 chance 
of being assigned to one treatment over the other. One consequence of 
participation is that the treatment to which the participant is assigned may be 
a less effective intervention. 

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b. It is hypothesized that Exposure, Relaxation, and Rescripting Therapy 
(ERRT) will be the more effective intervention because it contains the 
components that are suspected to be the mechanism of change.  However, 
we still have uncertainty about treatment effects, given that both treatments 
have shown reduction in symptoms. To ensure equipoise during recruitment, 
research staff will follow a script that presents balanced descriptions of the 
two treatments, and will not include study predictions.  
3. Risks associated with physiological assessment of sleep:  
a. Participants may experience slight discomfort associated with the attachment 
of electrodes, as well as slight restrictions in movement, during the 
polysomnography assessment. The sensors are unlikely to cause an allergic 
reaction; however, this cannot be completed ruled out. We have elected 
sleep assessment procedures that are as minimally invasive and as brief as 
possible. Therefore, mattress actigraphy will be used for most of the study 
period, which is a minimally invasive objective sleep assessment. 
b. It is possible that Veterans’ regular sleep partners, if present, may not wish to 
have the device on their bed. In the event of this situation, these Veterans will 
not be included in the study.  
c. It is possible that results from the sleep assessment may provide evidence for 
an underlying sleep disorder (e.g., obstructive sleep apnea), which may 
increase participant distress. However, if identified, participants will be 
provided referral information for the Sleep Center to receive appropriate 
clinical care. 
d. Some participants may be hesitant to have VA staff come to their home for 
the installation and removal of the mattress system. 
e. There is potential risk of having a re-usable device placed on the bed. 
Although a standard cleaning procedure will be employed (cleaning washable 
fabric, spraying with disinfectant, wiping down all wires with disinfectant, and 
spraying with a flame retardant) between uses there is rare, but plausible, risk 
that bedbugs are detected. In this case, healthcare policy procedures will be 
used.  Additionally, while rare, due t the forma inside the mattress system 
being a porous material, it is possible that it can absorb environmental odors 
that may be detectable to some users.  
4. Risk of loss of confidentiality:  
a. There exists the small chance that a breach of confidentiality may occur; 
however, substantial procedures will be put in place to limit the possibility of 
such a breach in confidentiality or privacy. All personal data will be coded, 
stored on secure Minneapolis VA research servers, or stored in locked 
cabinets in building 68, room 211 of the Minneapolis VA, which requires key 
access for entry.  
5. Except for travel to the VA for appointments, we do not anticipate any social or 
economic risks associated with this study. 
6. No legal risks are anticipated with this study.   

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• 
Protection against risks:  
o Consent process. The consent process will include complete discussion and 
review of potential risks and benefits associated with participation. Veterans will 
be informed that both initial and continued participation is voluntary, and that 
withdrawal from study procedures at any point in the study is within their rights. 
They will be informed that their clinical care in the VA will in no way be 
negatively impacted by their decision to withdraw participation. 
o Continuity of care. Participants who choose to withdraw early will be referred for 
other treatments within the MVAHCS to address their trauma symptoms and 
nightmares, and the PI will communicate appropriately with the participants’ 
providers to ensure adequate continuity of care and protect against adverse 
events.  
o Interviewer training and administration of interviews. All research staff will 
complete training in the protection of human subjects. Dr. Miller will coordinate, 
in the study set-up phase, a training session for the consenting process, 
diagnostic instruments, and determining general eligibility criteria. A portion of 
the training will include discussions on feeling comfortable discussing 
uncertainty about treatment effects, explaining that participants are suitable for 
both treatments, and explaining the rationale for randomization. All research 
staff also will complete training in the administration of the C-SSRS via an on-
line web training created by the developer of the scale. A didactic training will 
include role-plays, and discussion of differential diagnosis. A discussion of 
procedures to manage participants that become distressed by the interview 
process will be included in the training. Specifically, should an individual become 
distressed during the interviews, staff will be trained in relaxation procedures 
and will be instructed to pause the interview and ask the participants permission 
to continue or if they would prefer to stop the interview. Staff will then contact 
the PI who will meet with the participant to assess for level of distress and 
provide cognitive behavioral strategies for anxiety reduction. To move through 
the training, the trainee will be required to (1) complete the on-line training for 
the C-SSRS, (2) review available didactic videos on these materials, (3) view 
two live administrations by senior interviewers with the comparison of the 
trainee’s’ ratings to those of the senior interviewer, and (4) administer two 
interviews in the presence of the senior interviewer, with the requirement that 
the trainees’ assessment match those of the senior interviewer’s. Throughout 
the study, all clinical interviews will be administered by trained interviewers.  
o Protection against risk associated with self-report questionnaires and clinical 
interview. Minimal risk is associated with completion of the clinical interviews 
and self-report questionnaires. In fact, this is information that they likely will have 
discussed with members of their VA treatment team. However, risk will be 
further minimized in several important ways. First, all research staff will be 
trained in cognitive-behavioral strategies to reduce distress if a participant 
becomes distressed during any of the procedures. Second, participants will be 
informed they may cease participation in the study at any time without impacting 
their previous compensation or participation in VA services. The study 
environment will be made as comfortable as possible and participants will be 
given breaks throughout the course of the procedures, if needed. Veterans will 
also be provided with the number for the Veterans Crisis Line. 

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o Protection against risk associated with physiological assessment of sleep. As 
outlined above, the potential risks from the physiological assessment of sleep 
are minimal. In fact, these procedures are frequently used in both research and 
clinical domains among individuals with sleep disturbances. Several procedures 
will be implemented to further reduce potential risk of the polysomnography 
(PSG) study and the use of the mattress actigraphy system. A trained 
researcher will complete the procedures to attach the physiological monitoring 
electrodes for the PSG portion of the study. This researcher will clearly describe 
all the procedures to ensure participants comfort. The mattress actigraphy 
monitoring was selected due to its zero-burden, minimally-invasive nature (time, 
mobility) compared to numerous lab-based polysomnography assessments and 
other ambulatory devices requiring user adherence. The system proposed in the 
present study will fit over the Veterans usual mattress and has been employed 
successfully in previous research studies. Reports from previous participants 
indicated that the accelerometers in the mattress topper were virtually 
undetectable. There is no contact between the participants and the 
accelerometers which are, themselves, hermetically-sealed and robustly cabled. 
In fact, there are at least four layers of fabric, the spandex “trampoline” 
positioning the accelerometers and their cabling, the topper ticking, the 
disinfectable (and water-proof) fluid barrier, and the participant’s own sheet(s).  
Regarding electrical device safety standards, the following facts are pertinent.  
There are no electrical connections from the accelerometers to the patient, and 
electrical separation is provided by one grounded metallic shield (on the 
accelerometer) and three to four non-conductive fabric layers.  No AC mains 
power is conducted to the accelerometers, which are instead powered by two 
12-volt batteries.  The power drawn by the accelerometers is very small – on the 
order of 40 milliamps per device - yielding a total draw of 160 milliamps per bed.  
Accordingly, very low amperage (300 milliamp) fast-blow fuses are inserted in 
both the +12 VDC and –12 VCD power supply lines to the accelerometers 
proximate to the batteries.  In the rare circumstance, compromise of the 
insulation of a power and ground or signal line leading to a short circuit therefore 
causes immediate power shut off with minimal sparking. The wire bundle exiting 
each accelerometer is protected with a cut- and abrasion-resistant wire guard 
reducing the likelihood of shorts.  The accelerometers are hermetically sealed, 
making internal shorts due to spilled liquid unlikely, even if that liquid could pass 
the top barrier.  The batting and ticking near each accelerometer are sprayed 
with fire retardant.  Wire bundles leading to and from the mattress are wire-
guarded.  The batteries are covered during operation.  The computers used to 
collect accelerometric data are isolated from AC mains by circuit-breaker 
equipped power transformers yielding a maximum of +/- 12 VDC. This system is 
patent protected [US 6,485,441 B2]. In terms of protection of the data, the 
outputs of the accelerometer are fed directly to a data acquisition card hosted in 
a standard, password protected, encrypted hard drive. Data will be analyzed 
offline using various signal processing strategies. For cleanliness, the mattress 
topper is coated in a layer of non-absorbent, and tear-resistant nylon cloth. Prior 
to use with a new Veteran, this cover will washed and disinfected. In the rare, 
but plausible, situation that bedbugs were detected, healthcare policy 
procedures outlined by the medical center will be employed.  
o Protection against risk of harm to self or others. Active suicidal or homicidal 
intent are exclusionary criteria for the current study. Based on this, it is expected 

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that incidence of such events will be rather low. All Veterans will complete a 
screening to assess for active intent of harm to self or others. In the event an 
individual reports active suicidal or homicidal intent to research staff, the 
mentoring team will be notified. Individuals with active intent for harm to self or 
others will be referred to a higher level of care within MVAHCS (in the case of 
harm to self), or the VA police will be contacted (in the case of active intent to 
harm others). Should an individual endorse intent to harm self or other during 
phone calls or while researchers are in the Veteran’s home, staff will respond by 
following the system-wide Suicide/Crisis Flow chart. See study visit safety 
instructions in appendix for additional steps to ensure Veteran and research 
staff safety. 
o Protections to maintain confidentiality. The risk of breaches in confidentiality are 
minimal as many protections will be put in place to protect participants’ privacy. 
Research material obtained from participants will be interview assessments, 
self-report measures, and physiological measures. Breach of confidentiality is 
highly unlikely, as all data will be coded by arbitrary study number to ensure 
confidentiality and will be stored on a password protected VA computer. 
Consent forms with identifying information (names) will be filed separately from 
actual study data. A master list of names, phone numbers, and addresses will 
be kept in a separate location and used to facilitate the collection of data. Only 
the PI and the study coordinator will have access to this master list that links 
names and numbers. Audiotapes will be coded by study number and stored as 
an audio file on a password protected computer within the research study folder. 
These files will be maintained in this secure location and destroyed according to 
the VA Federal Records requirements in the VHA Record Control Schedule 
(RCS 10-1), currently at 6 fiscal years following the closure of the study. Only 
the PI, members of the collaboration team, and trained research staff will have 
access to these data. No identifiable information will be included in any 
published works or conference presentations that involve study data.    
• 
Anticipated Benefits:  
1. Societal benefits – The goals of the research plan are directly relevant to the 
VHA patient care mission, and have both short- and long-term implications for 
Veterans’ mental health. Much of what is currently known about trauma-related 
nightmares is limited by in-laboratory sleep studies or cross-sectional designs, 
which cannot identify the changes that may occur from treatment or the potential 
factors associated with such changes. The proposed study will begin to directly 
address the current limitations and provide a basis for practical changes to 
treatment protocols. 
2. Participant benefits – 
a. Participants will complete an ambulatory sleep assessment which will 
include screening for sleep apnea. This is typically a costly assessment 
and one that is often met with a substantial waitlist given the limited 
number of sleep laboratories. Participants may gain knowledge about 
their sleep disturbances and receive referral information for treatment, if 
needed.  
b. Participants eligible for the treatment portion of the study will receive five-
session of a treatment directly targeting their nightmare complaints.  

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c. It is possible that participants may not experience any direct benefit from 
participation.  
• 
Study population:  All participants recruited for this study will be adult Veterans (Age 
18 or older). There are no restrictions on the inclusion of racial or ethnic minorities or 
gender and sex for the present study. Care will be taken to ensure that the 
demographics of our sample closely approximate the demographic make-up of the 
MVAHCS. As some Veterans served in our facility are economically disadvantaged, 
employees, or students, there is a possibility that the participant population will 
include these categories of individuals. We plan to obtain complete data from 41 
Veterans from the MVAHCS. To reach this number, we expect some Veterans 
following consent and enrollment will withdraw, be lost to follow-up, or be excluded. 
Therefore, we anticipate enrolling 57 Veterans.  
• 
Added protections: This study may include participants who are 
economically or educationally disadvantaged. Procedures to minimize 
risk, as outlined above, will be employed with all participants regardless of 
their socioeconomic or educational status. Payment is provided to ensure 
adequate compensation for the Veteran’ involvement in the study. We 
also will ensure that the informed consent is at a 6th grade reading level.  
• 
No data and specimen banking will occur in this study.  
5.2 Recruitment Methods 
• 
Results from power calculations suggested that a total sample of 80 is 
needed for randomization. To account for likely 20% loss during the study 
period, we plan to recruit and enroll 96 Veterans, with the goal of 
randomizing 80 Veterans for the treatment phase of the study. 
Specifically at the MVAHCS, we need a sample of 41 Veterans for 
randomization. To account for anticipated loss during the study period, we 
plan to recruit and enroll 57 Veterans from MVAHCS.    
• 
Potential participants will be identified and recruited through several 
methods: 
o Clinician referrals: The PI And study coordinator will provide 
information and give presentations about the study to providers at 
the MVAHCS, who serve Veterans who may be potentially eligible 
for the study. A clinician handout about the study and information 
sheet is included with the recruitment materials. If these providers 
believe their patients may be eligible or would be interested, they 
may provide the PI or study coordinators’ contact information. 
Therefore, participants may be identified through referrals from 
providers in the sleep center, primary care clinic, and/or specialty 
mental health. Only after initial discussion of the study with the 
patient and the patients’ agreement, the referring provider will 
provide the research team with the name and contact information 
of each Veteran. The study team will remind the provider that they 
must document this referral in the patient’s chart.  
o Flyers: Flyers advertising this research study with contact 
information will be placed within MVAHCS and VA-sponsored 
social media with approval.  

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o Letters: We also will recruit Veterans through mail, based on 
clinical patient data extracted using the VA informatics and 
computing infrastructure (VINCI), which includes real SSN. Letters 
will be sent by the PI and study coordinator.  
• 
As mentioned above, approved flyers will be posted at MVAHCS to 
advertise the study. Clinical providers may give an information sheet to 
their patients, and recruitment letters will be sent to potential participants. 
Interested participants can also contact the numbers listed on these 
documents. The PI will request to post IRB-approved flyers to VA-
sponsored social media through the MVAHCS public affairs office.  
• 
Each participant may be paid up to $330.00 for their participation in the 
different parts of the study, on the following payment schedule:  
o $30 for the completion of the baseline screening procedures 
o $100 for completing the baseline actigraphy sleep monitoring (1-week)  
o $75 for completing the baseline polysomnography study (1-night)  
o $50 for completing sleep monitoring during treatment  
o $50 for completing posttreatment assessment 
o $25 for completing a three-month follow-up assessment via 
telephone/video 
o Method: Payment will be in the form of a debit card or EFT/direct 
deposit.   
o No delay for receiving the payment is anticipated. 
5.3 Informed Consent Procedures 
• 
Written or electronic informed consent with an embedded HIPAA 
authorization will be obtained from all participants prior to the start of the 
baseline evaluation assessment.  Participants will be provided with a copy 
of the signed informed consent. The consent will provide information 
about the purpose of the study, include a section discussing audio-
recording of assessments and treatment sessions, a disclosure statement 
about consultation, a request to be able to speak with the Veterans’ 
regular bed partner about the mattress topper (if the bed partner contacts 
the study team regarding questions about the system), and will include a 
section on contacting the participants via text (on an authorized VA-
issued phone per ORD guidance documentation), email, and/or 
HealtheVet secure messaging. An information sheet will be provided to 
enrolled participants’ regular bed partners (i.e., individuals who sleep in 
the Veteran’s bed for a majority of the week) to inform them of the 
placement of the mattress device on the bed. The study team will only 
speak to Veterans’ partners with the Veteran’s consent, and will only 
discuss the topper and will not disclose treatment or symptom 
information. 
• 
The PI and study coordinator will obtain informed consent. The inability to 
provide fully-informed written consent to participate is an exclusion 
criterion; therefore, no special circumstances will need to be addressed 
for this consenting process.  

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• 
All personnel who will obtain informed consent will complete the local 
necessary VA trainings related to privacy, data security, and human 
subjects’ protections. The PI also will conduct in-person training of the 
consent process. This training will include role-plays and live supervision 
of the process.  
5.4 Inclusion/Exclusion Criteria 
• 
Inclusion: To be included, an individual must (1) be a Veteran aged 18 or older; (2) 
have stable housing for the duration of the study period; (3) have experienced any 
traumatic event meeting Criterion A for PTSD at least three months before the 
baseline assessment; (4) meet criteria for a current PTSD diagnosis (defined by the 
DSM-5 criteria) or subthreshold criteria, defined as follows: (a) The Majority definition 
– requiring participants to have met most PTSD diagnostic criterion (4 of the 5 
symptom clusters); and/or (b) The 6-plus definition – requiring participants to have at 
least 6 total symptoms, but may not meet full criterion specifiers; (5) self-report 
experiencing trauma-related nightmares (dream imagery with dysphoric emotions 
that arise or worsen following a traumatic event), at least once per week for the past 
month, that are mostly-remembered; (6) self-report global sleep disturbance 
indicated by a score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI); (7) 
be stable on medications. 
• 
Exclusion: The following will serve as exclusion criteria: (1) inability to provide fully 
informed consent to participate; (2) a bed partner does not agree to mattress 
recording during the in-home portion of the study; (3) a medical condition that limits 
ability to apply the treatment (e.g., needing a health aide or caregiver to record sleep 
diaries, unable to get out of bed without assistance); (4) current pregnancy and/or 
birth of a child within the past 6 months; (5) current alcohol or illicit substance use 
disorders or early remission; (6) active suicidal ideation or homicidal ideation; (7) a 
history of any bipolar disorder spectrum disorder or psychotic disorder; (8) 
hospitalization for a mental health disorder in the past 2 months; (8) enrolled in a 
current manualized PTSD-focused treatment (e.g., Cognitive Processing Therapy or 
Prolonged Exposure), (9) current nightmare treatment or a history of treatment failure 
with cognitive-behavioral therapy for nightmare intervention. Veterans may also be 
excluded from participation if they have been identified by local VA disruptive 
behavior committee to have displayed disruptive, threatening and/or violent behavior. 
 
5.5 Study Evaluations 
• 
Before being enrolled in the study, all potential participants will go through 
a phone screening process to assess their appropriateness for the current 
study. The criteria assessed in the phone screen consist of the following: 
the participant must (1) be 18 years of age or older at the time of the 
intake; (2) have experienced a traumatic event, as defined by the DSM-5; 
(3) have approximately one nightmare each week for the past month. A 
brief screener of past month PTSD symptoms will be conducted to assess 
for a probable PTSD diagnosis. Questions regarding psychological 
disorders and untreated substance dependence will be used to assess 
exclusion criteria. Participants who meet the criteria for inclusion based 
on the phone screen, and if interested, will be scheduled for an in-person 
evaluation. Screenings will take approximately 5 - 10 minutes. See 
appendix for telephone screening script. 

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• 
A demographic questionnaire will obtain standard background information 
about the participants: age, gender, race and ethnicity, sexual orientation, 
marital status, educational achievement, military branch of service, 
highest rank of service, eras of service, vocational status, household 
income, and living/housing situation. 
• 
Pharmacotherapy and OTC/Substance Use –The use of 
pharmacotherapy will be assessed at each session and will be 
corroborated with review of the electronic medical chart. These methods 
will assess class of medication (SSRI/SNRI, benzodiazepine, non-
benzodiazepine drug that acts at the benzodiazepine receptor, trazodone, 
prazosin, atypical anti-psychotic), dosage, schedule, and use since the 
previous assessment. 
• 
Clinician Administered PTSD Scale (CAPS-5) –The CAPS-5 is a 
structured clinical interview to assess full and subthreshold PTSD 
diagnosis and is the gold standard for PTSD assessment. The CAPS-5 
assesses current and lifetime PTSD and allows for the assessment of the 
frequency and intensity of PTSD symptoms, the impact of the symptoms 
on social and occupational functioning, the overall severity of symptoms, 
global improvement since baseline, and the validity of ratings obtained. 
• 
Mini International Neuropsychiatric Interview (MINI) – The MINI, is a brief, 
structured diagnostic interview that will be used to assess current mental 
disorders. The most recent version (7.0.2 for DSM-5) will be used. 
Because it is important to the current application that individuals with any 
history of bipolar disorder, manic symptoms, and/or psychotic symptoms 
be excluded from participation, the bipolar and psychotic disorder 
modules of the MINI will also be used to assess for lifetime symptoms. 
The substance use sections will be used to assess for alcohol and 
substance use disorders in the last 12 months. The MINI has been well 
validated and shown to be a comparable instrument to other established 
diagnostic interviews, with the advantage of being brief and easily 
administered by clinicians or research assistants. 
• 
Columbia-Suicide Severity Rating Scale (C-SSRS) - The C-SSRS will be 
used to screen for suicidal ideation and behavior. The C-SSRS assesses 
these two categories: 1) Level of suicidal ideation (scores range 0 – 5, 
with a score of 0 indicating no suicidal ideation, and scores 4 and 5 
indicating current serious suicidal ideation). If suicidal ideation is present, 
follow-up questions about the most severe thought are asked to 
determine the intensity of the ideation. These questions include: 
frequency, duration, controllability, deterrents, and reasons for that 
thought. 2) Suicidal behavior, with those reporting recent attempts and 
preparatory behaviors within the past three months at the highest risk. 
Participants who are deemed to be at high risk on the C-SSRS (a score of 
4 or 5 on suicidal ideation, and/or report active suicidal behavior, 
including recent attempt or preparatory behaviors, within the last three 
months) will be assessed further for risk and safety. Imminently suicidal 
Veterans will be escorted to the Emergency Department for further 
evaluation. Veterans determined to be a high risk but not in need of 
emergency care will receive MVAHCS standard procedures, including 
creating a safety plan and follow-up by the Suicide Prevention 

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Coordinator. He/she will be compensated for the baseline and excluded 
from study participation.   
• 
Depressive symptom inventory suicidality subscale (DSI-SS) – The DSI-
SS is a self-report measured used to detect and prevent suicidal ideation. 
This will be used in conjunction with the C-SSRS at the baseline, and 
used at post-treatment assessments. 
• 
Epworth Sleepiness Scale (ESS) – The ESS is a 8-item self-report 
measure used to assess daytime sleepiness. 
• 
PTSD Checklist for the DSM 5 (PCL-5) –The PCL-5 is a 20-item self-
report measure widely used in the VA that assesses the 20 DSM-5 
symptoms of PTSD. 
• 
Patient Health Questionnaire (PHQ-9) –The PHQ-9 is a 9-item self-report 
instrument used widely in the VHA to assess depression symptoms in 
Veterans. 
• 
Trauma-Related Nightmare Scale (TRNS) –The TRNS is a self-report 
measure developed by the ERRT developers for the assessment of 
trauma-related nightmares and related sleep disturbance. This measure 
will be used for nightmare frequency and related severity: the number of 
nights with nightmares per unit of time (e.g., per week), number of 
nightmares per unit of time, and severity associated with those 
nightmares. 
• 
Nightmare Effects Survey (NES) –The NES is an 11 item Likert-type 
questionnaire designed to assess the impact of nightmares on 11 areas 
of life including work, social, and leisure activities. Total scores range 
from 0 to 44, with higher scores indicating greater level of nightmare-
related impairment. 
• 
Nightmare Disorder Index (NDI) – The NDI is a 5-item questionnaire 
designed to assess the presence of nightmare disorder. 
• 
Pittsburgh Sleep Quality Index (PSQI) –The PSQI is a self-report 
measure designed to assess certain qualities and problems associated 
with sleep. Participants rate their quality of sleep and the degree of sleep 
difficulties for the month preceding the assessment. 
• 
Pittsburgh Sleep Quality Index—Addendum for PTSD (PSQI-A) –The 
PSQI-A is a self-report instrument used in conjunction with the PSQI for 
use with trauma-exposed participants and assesses the presence of 
seven trauma-related sleep disturbances. 
• 
Fear of Sleep Inventory-Short Form (FoSI-SF) —The FoSI-SF is a 23-
item self-report measure that assesses trauma-related thoughts and 
activities associated with sleep and the occurrence of traumas associated 
with the bedroom or sleep. 
• 
Sleep and Nightmare Diary - This diary is used to monitor self-reported 
sleep/wake behaviors and nightmare frequency and severity. Participants 
record their subjective estimates of important sleep parameters such as 
sleep time, wake time, number of awakenings, length of awakenings, 
naps, and subjective sleep quality every night. Additionally, they will 

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report nightmare frequency and severity, other dream frequency, daytime 
nightmare-related distress, and daily homework compliance (i.e., yes/no- 
did they practice relaxation and rescripting procedures). 
• 
Homework Effort question- One question will be administered prior to the 
start of treatment sessions inquiring about the participant’s level of effort 
they exerted in working on changes between sessions. 
• 
Treatment Credibility & Expectancy Questionnaire—Following the first 
session, participants will be administered the 6-item self-report measure 
that assesses individuals’ perceptions of the credibility of and 
expectations about the treatment. 
• 
Treatment session standard operating procedures and checklists – 
Following each treatment session, the study therapist will complete a 
checklist to ensure they completed the tasks outlined for the session and 
to rate the participant’s completion of homework tasks. 
Objective Sleep Assessment:  
• 
Mattress Actigraphy in Veterans’ Homes –To obtain an objective measurement of 
sleep in the Veterans’ usual sleep environment participants will sleep while 
monitored by a mattress actigraphy system each night for one week during the 
baseline phase of the study, Veterans randomized to ERRT or to the comparison 
treatment will continue to sleep while monitored by the mattress system during the 
five-week treatment period and one week following the last treatment session. The 
mattress actigraphy system uses four sensitive, low-noise, micro-electro-mechanical 
(MEMS) accelerometers (Silicon Designs, Issaquah, Washington, Model 2210 2 g, 
bandwidth: 0–300 Hz) embedded in the thorax region of a mattress topper that will 
be placed on top of the participant’s regular mattress, and under a regular 
bedsheets. Accelerometers will be connected to a 12-volt medical grade power 
supply and signals will be routed to a bedside hard-drive data acquisition card 
(Kiethley KPCI-3807, sampling rate, 600 Hz), and custom software managing the 
nighttime collection and daytime preprocessing of accelerometer signals into 30-
second epochs with heart rate; RSA; respiratory parameters, including rate, rate 
variability, and amplitude variability; and body movement parameters. Of great 
importance for this proposal, assessing RSA during sleep offers additional protection 
from sources of artifact such as movement and speech, and allows long recording 
periods promoting reliable estimates. An event marker (a button connected to the 
mattress system), which can be activated by the participant to mark nightmare 
occurrences during the night, will be placed near the bed and linked to the sleep 
record. Participants will be requested to activate the button upon waking from a 
nightmare. An instruction sheet is included in the appendix. Overall, the mattress 
actigraphy system has been employed successfully over 40,000 nights by the study 
collaborator, Dr. Woodward [9-11], as part of research at the VA Palo Alto 
Healthcare System. 
 
• 
Home-based polysomnography (PSG): A home-based overnight polysomnography 
(PSG) study will be conducted using a Nox A1 portable polysomnography system 
(Nox Medical) to record sleep stage measures and patterns of arousal. This system 
acquires the following signals: electroencephalogram (EEG), horizontal 
electrooculogram (EOG), chin electromyogram (EMG), electrocardiogram (ECG), 

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chest circumference (impedance plethysmography), abdominal circumference, nasal 
pressure, left and right leg movement (via accelerometry), oxygen saturation (SpO2), 
and body position (right lateral, left lateral, prone, and supine). Based on these 
signals, data on sleep staging, body position, total sleep time, and sleep efficiency 
will be obtained.  
 
 
 
• 
Schedule of assessments. 
Baseline 
Treatment and Follow-up 
Baseline 
Screening 
Evaluation 
Baseline 
Sleep 
Monitoring 
(1 week) 
Treatment 
Visits 
(5 weeks) 
Time 2 
Follow-
up 1 
week 
post-
treatment 
Time 3 
Follow-
up 3 
months 
post-
treatment 
MINI 
X 
CAPS-5 
X 
X 
X 
C-SSRS 
X 
X 
X 
DSI-SS 
X 
X 
X 
ESS 
X 
X 
X 
NDI 
X 
X 
X 
PCL-5 
X 
X 
X 
X 
PHQ-9 
X 
X 
X 
X 
PSQI 
X 
X 
X 
X 
PSQI-A 
X 
X 
X 
TRNS 
X 
X 
X 
X 
Picture: Mattress topper that shows the 
thickness and how it fits over a standard 
mattress. A standard fitted sheet goes over 
it. The Sensorbed is the size of a standard 
twin mattress 39”x”75”, allowing it to be 
placed on any size mattress and positioned 
where the Veteran typically sleeps. 
Picture: shows the event marker (the button 
connected to the Sensorbed system). 
When pressed by the participant, it will 
create a mark in the participant’s data. 
Participants will be requested to press this 
button upon waking from a nightmare. 

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CEQ 
X (1st visit 
only) 
NES 
X 
X 
X 
FOSI-SF 
X 
X 
X 
Demographics 
X 
PMI 
X 
X 
X 
X 
Sleep Diary 
X 
X 
X 
X 
Polysomnogra
phy (1 night) 
X 
Mattress 
Actigraphy 
(nightly) 
X 
X 
X 
Treatment 
Checklist 
X 
 
5.6 Data Analysis 
• 
Results from a power calculation suggested that a sample of 80 is 
needed for randomization to detect smaller effects in terms of the primary 
aims. This sample size will also allow for adequate power to detect group 
differences between ERRT (n = 40) and the comparison group (n = 40). 
We will account for approximately 20% loss during the study period. 
Therefore, we aim to recruit and enroll 96 individuals, with the goal of 
randomizing 80 individuals for the treatment phase of the study. At the 
MVAHCS, we anticipate recruiting and enrolling 57 Veterans, with the 
goal of randomizing 41 individuals for the treatment phase of the study.  
• 
Data analysis will occur using MATLAB and R Studio. The general 
analytical plan is as follows; however, the specifics may be adjusted as 
new methodology emerges over the study period:  
o Regarding Aim 1: Mixed-effects binary logistic regressions, a 
version of generalized linear mixed modeling (GLMM) will be used 
to model the binary outcome (nightmare versus non-nightmare 
night) from predictor variables. This method accommodates the 
daily values derived from the mattress actigraphy system and self-
report diary data, and missing data, in the potential event of 
mattress or PSG system errors, and/or missing diary data. For the 
exploratory hypothesis: change point analysis will be used as it is 
designed to detect significant changes in time series data [12]. 
This method can be used to detect a sustained change in 
physiological measure that may trigger a psychological 
phenomenon (e.g., a decrease in sleep RSA may precipitate a 
nightmare).  
o Regarding Aim 2: A combination of GLMM and growth analysis 
will be used for this aim. GLMM provides the most parsimonious 
test of our hypotheses based on the following considerations. 
First, this method accommodates attrition and missing data, in the 
potential event of mattress system errors, missed assessments, 
and study dropout. Second, GLMM allows for modeling sleep and 
change over time. Importantly, this approach allows model change 

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in nightmare frequency, sleep RSA, and actigraphic sleep 
efficiency over the course of short-term (weekly) and long-term 
(post-assessments), while also allowing the modeling of any 
unpredicted change in sleep disturbances during the treatment 
phase.  
5.7 Withdrawal of Subjects 
 
• 
It is possible that, based on information gained from this study, the 
researchers may have serious concerns (related to matters such as life-
threatening events, physical abuse, etc.) about the participants’ health 
and safety, in such a case, the researchers may withdraw participants 
from the study, and/or contact them to provide a referral for additional 
care. In addition, the PI may withdraw participants from the study for one 
or more of the following reasons:  
o It is determined that continuing participation would be harmful to 
the participant.  
o It is determined during the study that the participant needs 
treatment not provided in this study.  
o The participant becomes pregnant during the study.  
o The participant verbally or physically threatens the safety of the 
research staff.  
o The participant dos not follow study procedures (e.g., not 
attending treatment sessions, not regularly sleeping in their bed 
with the mattress topper, unplugging equipment).  
o The study is cancelled.  
• 
Participants can withdraw from the study at any time without penalty or 
loss of benefits they may be entitled. We will call participants to complete 
a final assessment and arrange a time to pick-up any study equipment in 
the home. Although, it is preferable for subjects to utilize the HIPAA 
Revocation form if withdrawing from the study.  
6 Reporting 
• 
All protocol deviations, adverse events, serious adverse events, breaches of 
confidentiality, UADE’s, unanticipated or unexpected problems will be reported 
by the PI to the IRB in writing within 5 business days of discovery. 
• 
These reports also will be sent to the CSR&D Data Monitoring Committee. All 
SAEs and UPIRTSOs must be reported to the DMC within 3 business days of the 
time of discovery.  
7 Privacy and Confidentiality 

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• 
PHI collected from this study will not be disclosed. Any PHI collected will be 
coded with a unique participant ID that will be used as identification on all study 
documents except the informed consent form.  
• 
Questionnaire data will be collected via paper, or electronically via REDCAP (if 
the Veteran is within the VA firewall, for example completing a visit on site) or 
Qualtrics (if the Veteran is off-site). REDCap is a service on the VA Informatics & 
Computing Infrastructure (VINCI) server maintained by VINCI and VA information 
Resource CENTER (VIReC). The servicer is located behind the VA firewall. 
Clinical interview data will be entered directly onto computers at the research 
site. Qualtrics also will be used for data collection throughout the study. Qualtrics 
is approved in the Digital VA Product Marketplace and is housed in the 
FedRAMP environment. Qualtrics has a FedRAMP Security Certification, a gold 
standard for security certifications. Qualtrics is approved for “moderate” level 
data security, which includes PHI/PII. Data from REDCap and Qualtrics will be 
periodically downloaded and stored within the secure MVAHCS research server, 
in the study folder that only approved research staff can access.  
• 
Mattress actigraphy and the polysomnography data will be coded with a Study 
ID.  These data will be stored within the secure MVAHCS research server, with 
access limited to only approved research staff.  
• 
Identifiable information obtained from the research coordinator and/or collected 
via phone screen will be name, phone number, dates, email address, mailing and 
home address, and last 4 of SSN. This information will be kept separate from all 
study data.  
8 Communication Plan 
• 
Study recruitment will only occur at the Minneapolis VA Health Care System.  
The PI will routinely be in touch with the career development award mentors and 
consultants to discuss any study-related concerns.  
• 
The research coordinator will be trained to adhere to all stipulations of the IRB- 
approved protocol. Within the first month of recruitment, a random spot-check will 
be conducted to ensure that all procedures are being followed according to the 
protocol.  
9 References 
1. Neylan TC, Marmar CR, Metzler TJ, Weiss DS, Zatzick DF, Delucchi KL et al. Sleep 
disturbances in the Vietnam generation: findings from a nationally representative sample 
of male Vietnam veterans. Am J Psychiatry. 1998;155(7):929-33. 
doi:10.1176/ajp.155.7.929.  
2. Seelig AD, Jacobson IG, Smith B, Hooper TI, Boyko EJ, Gackstetter GD et al. Sleep 
patterns before, during, and after deployment to Iraq and Afghanistan. Sleep. 
2010;33(12):1615-22.  
3. Gellis LA, Gehrman PR, Mavandadi S, Oslin DW. Predictors of sleep disturbances in 
Operation Iraqi Freedom/Operation Enduring Freedom veterans reporting a trauma. Mil 
Med. 2010;175(8):567-73.  

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4. Miller KE, Jaffe AE, Davis JL, Pruiksma KE, Rhudy JL. Relationship between self-
reported physical health problems and sleep disturbances among trauma survivors: a 
brief report. Sleep Health: Journal of the National Sleep Foundation. 2015;1(3):166-8.  
5. Vandrey R, Babson KA, Herrmann ES, Bonn-Miller MO. Interactions between disordered 
sleep, post-traumatic stress disorder, and substance use disorders. Int Rev Psychiatry. 
2014;26(2):237-47. doi:10.3109/09540261.2014.901300. 
6. Maguen S, Stalnaker M, McCaslin S, Litz BT. PTSD subclusters and functional 
impairment in Kosovo peacekeepers. Mil Med. 2009;174(8):779-85.  
7. Department of Veterans Affairs, Defense Do. VA/DoD clinical practice guideline for the 
management of posttraumatic stress disorder and acute stress disorder2017.  
8. Balliett NE, Davis JL, Miller KE. Efficacy of a brief treatment for nightmares and sleep 
disturbances for veterans. Psychol Trauma. 2015;7(6):507-15. doi:10.1037/tra0000055. 
9. Woodward SH, Arsenault NJ, Voelker K, Nguyen T, Lynch J, Leskin G et al. Estimating 
heart rate and RSA from the mattress-recorded kinetocardiogram. Psychophysiology. 
2007;44(4):635- 8. doi:10.1111/j.1469-8986.2007.00526.x.  
10. Woodward SH, Arsenault NJ, Voelker K, Nguyen T, Lynch J, Skultety K et al. Autonomic 
activation during sleep in posttraumatic stress disorder and panic: A mattress actigraphic 
study. Biol Psychiatry. 2009;66(1):41-6. doi:10.1016/j.biopsych.2009.01.005.  
11. Miller KE, Jamison AL, Gala S, Woodward SH. Two independent predictors of 
nightmares in PTSD. J Clin Sleep Med. 2018;14(11):1921-7.  
12. Rosenfield D, Zhou E, Wilhelm FH, Conrad A, Roth WT, Meuret AE. Change point 
analysis for longitudinal physiological data: detection of cardio-respiratory changes 
preceding panic attacks. Biological psychology. 2010;84(1):112-20.