Cognitive Behavioral Therapy for Insomnia in Chronic Traumatic Brain Injury
Phase: NA
Conditions: Insomnia, Traumatic Brain Injury
Sponsor: VA Office of Research and Development

Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury 
NCT03261674 
9/27/2024 

Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025
Personnel Info .............................................................................................................
2
Participant Population .................................................................................................
5
Study Location ............................................................................................................
5
General Checklist ........................................................................................................
6
Funding .......................................................................................................................
8
Resources ....................................................................................................................
8
Purpose, Study Procedures .......................................................................................... 10
Radioisotopes or Radiation Machines ......................................................................... 15
Drugs,Devices,Reagents ............................................................................................. 16
Medical Equipment for Human Subjects and Laboratory Animals ............................ 16
Participant Population(a-g) ......................................................................................... 16
Participant Population(h-m) ........................................................................................ 18
Risks(a-e) .................................................................................................................... 20
Privacy And Confidentiality ....................................................................................... 24
Conflict Of Interest ..................................................................................................... 24
Consent Background ................................................................................................... 28
Assent Background ..................................................................................................... 31
HIPAA Background .................................................................................................... 31
Attachments ................................................................................................................. 33
Obligations .................................................................................................................. 38
eProtocol # 41040 ( Continuing Review )
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APPLICATION FORM
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Review Type: Regular
Human Subjects Research
Medical
Stanford University

Protocol Director
Name
Ansgar Furst
Degree (Program/year if
student)
PhD
Position, e.g. Assistant Professor,
Resident, etc.
Clinical Associate Professor
(Affiliated) [VAPAHCS]
Department
Psych/Public Mental
Health & Population
Sciences
Phone
650-493-5000
x68652
E-mail
ansgar.furst@va.gov
CITI Training current
Y
Admin Contact
Name
Rayma Williams
Degree (Program/year if
student)
BS
Position, e.g. Assistant Professor,
Resident, etc.
Study Coordinator
Department
Psychiatry VA
Research
Phone
650-493-5000
x64564
E-mail
rayma.williams@va.gov
CITI Training current
Y
Investigator
Name
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Department
Phone
E-mail
CITI Training current
Other Contact
Name
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Department
Phone
E-mail
CITI Training current
Academic Sponsor
Name
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Department
Phone
E-mail
CITI Training current
Other Personnel
Name
Donn Posner
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Adjunct Clinical Associate Professor
Department
5717
Phone
E-mail
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

Psychiatry and
Behavioral Sciences
Donn.Posner@va.gov
CITI Training current
Y
Name
Odette Althea Harris
Degree (Program/year if
student)
M.D., M.P.H.(VA)
Position, e.g. Assistant Professor,
Resident, etc.
Professor-Med Ctr Line
Department
Neurosurgery
Phone
(650) 723-5574
E-mail
Odette.harris@va.gov
CITI Training current
Y
Name
Jon-Erik Holty
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Clinical Assistant Professor (Affiliated)
[VAPAHCS]
Department
Phone
(650) 493-5000
(650) 852-3276 E-mail
Jon-Erik.Holty@va.gov
CITI Training current
Y
Name
Jerome A Yesavage
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Professor
Department
Psych/Public Mental
Health & Population
Sciences
5550
Phone
(650) 852-3287
(650) 852-3297 E-mail
Jerome.Yesavage@va.gov
CITI Training current
Y
Name
Jamie Marc Zeitzer
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Assoc Professor-Research
Department
Psych/Sleep Medicine
5550
Phone
E-mail
jamie.zeitzer@va.gov
CITI Training current
Y
Name
Beatriz Hernandez
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Data Analyst
Department
Psych/Public Mental
Health & Population
Sciences
5550
Phone
(650) 852-3287
E-mail
Beatriz.hernandez@va.gov
CITI Training current
Y
Name
Arthur Noda
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Research Data Analyst
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

Department
Phone
(650) 493-5000
(650) 852-3297 E-mail
Arthur.noda@va.gov
CITI Training current
Y
Name
Jennifer Shinae Jennings
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Clinical Director
Department
Phone
E-mail
Jennifer.jennings2@va.gov
CITI Training current
Y
Name
Dr. G. Marina Veltkamp Prev. Arzola
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Neuropsychologist
Department
Phone
650.493.5000
E-mail
gladys.veltkamp@va.gov
CITI Training current
Y
Name
Halee Nicole Staggs
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Research Assistant
Department
Psychiatry and
Behavioral Sciences
Phone
E-mail
halee.staggs@va.gov
CITI Training current
Y
Name
Valeria Alvarado
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Research Assistant
Department
Psychiatry and
Behavioral Sciences
Phone
E-mail
valeria.alvarado@va.gov
CITI Training current
Y
Name
Gloria Juliana Kindt Maramba
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Psychologist
Department
Psychiatry VA
Research
5717
Phone
E-mail
gloria.maramba@va.gov
CITI Training current
Y
Name
Chun-Ping Liao
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Life Science Research Asst
Department
Psychiatry and
5485
Phone
(650) 723-0056
E-mail
phoebel@stanford.edu
Protocol # 41040 ( Continuing Review )
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PD: Ansgar Furst
APPLICATION FORM
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

Behavioral Sciences -
Child and Adolescent
Psychiatry and Child
Development
CITI Training current
Y
Name
Rachel Manber
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Professor-Univ Med Line
Department
Psych/General
Psychiatry and
Psychology (Adult)
5797
Phone
(650) 498-1266
(650) 723-4655 E-mail
rmanber@stanford.edu
CITI Training current
Y
Participant Population(s) Checklist
Yes/No
• Children (under 18)
N
• Pregnant Women and Fetuses
N
• Neonates (0 - 28 days)
N
• Abortuses
N
• Prisoners
N
• International Participants
N
Please enter the countries separated by comma
• Impaired Decision Making Capacity
N
• Cancer Subjects
N
• Laboratory Personnel
N
• Healthy Volunteers
N
• Students
N
• Employees
N
• Other (i.e., any population that is not specified above)
Y
Study Location(s) Checklist
Yes/No
• Stanford University
• Clinical & Translational Research Unit (CTRU)
• Stanford Medicine Health Care
Tri-Valley
• Stanford Medicine Children's Health
• VAPAHCS (Specify PI at VA)
Y
Ansgar J. Furst, PhD
• Other (Click ADD to specify details)
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

General Checklist
1. Multi-site
Yes/No
• Is this a multi-site study? A multi-site study is generally a study that involves one or more
medical or research institutions in which one site takes a lead role.(e.g., multi-site clinical
trial)
N
2. Collaborating Institution(s)
Yes/No
• Are there any collaborating institution(s)? A collaborating institution is generally an
institution that collaborates equally on a research endeavor with one or more institutions.
N
3. Cancer Institute
Yes/No
• Cancer-Related Studies (studies with cancer endpoints), Cancer Subjects (e.g., clinical
trials, behavior/prevention) or Cancer Specimens (e.g., blood, tissue, cells, body fluids with
a scientific hypothesis stated in the protocol).
N
4. Clinical Trials
Yes/No
• Investigational drugs, biologics, reagents, or chemicals?
N
• Commercially available drugs, reagents, or other chemicals administered to subjects that
are being studied?
N
• Investigational Medical Device / Commercial Medical Device used off-label or if being
studied?
N
• IDE Exempt Device (Commercial Medical Device used according to label, Investigational
In Vitro Device or Assay, or Consumer Preference/Modifications/Combinations of
Approved Medical Devices)
N
• Will this study be registered on clinicaltrials.gov? ( See Stanford decision tree )
Y
• Who will register for ClinicalTrials.gov?
NCT# 03261674
N
5. Tissues and Specimens
Yes/No
• Human blood, cells, tissues, or body fluids (tissues)?
Y
• Tissues to be stored for future research projects?
Y
• Tissues to be sent out of this institution as part of a research agreement? For guidelines,
please see Material Transfer Agreements
N
6. Biosafety (APB)
Yes/No
Protocol # 41040 ( Continuing Review )
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PD: Ansgar Furst
APPLICATION FORM
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

• Are you submitting a Human Gene Transfer investigation using a biological agent or
recombinant DNA vector? If yes, please complete the Gene Transfer Protocol Application
Supplemental Questions and upload in Attachments section.
N
• Are you submitting a Human study using biohazardous/infectious agents? If yes, refer to
the Administrative Panel on BioSafety website prior to performing studies.
N
• Are you submitting a Human study using samples from subjects that are known or likely to
contain biohazardous/infectious agents? If yes, refer to the Administrative Panel on
BioSafety website prior to performing studies.
N
7. Human Embryos or Stem Cells
Yes/No
• Human Embryos or Gametes?
N
• Human Stem Cells (including hESC, iPSC, cancer stem cells, progenitor cells)
N
8. Veterans Affairs (VA)
Yes/No
• The research recruits participants at the Veterans Affairs Palo Alto Health Care
System(VAPAHCS).
Y
• The research involves the use of VAPAHCS non-public information to identify or contact
human research participants or prospective subjects or to use such data for research
purposes.
Y
• The research is sponsored (i.e., funded) by VAPAHCS.
Y
• The research is conducted by or under the direction of any employee or agent of
VAPAHCS (full-time, part-time, intermittent, consultant, without compensation (WOC),
on-station fee-basis, on-station contract, or on-station sharing agreement basis) in
connection with her/his VAPAHCS responsibilities.
Y
• The research is conducted using any property or facility of VAPAHCS.
Y
9. Equipment
Yes/No
• Use of Patient related equipment? If Yes, equipment must meet the standards established by
Biomedical Engineering (BME) (650-725-5000)
Y
• Medical equipment used for human patients/subjects also used on animals?
N
• Radioisotopes/radiation-producing machines, even if standard of care? ; More Info
N
10. Payment
Yes/No
• Subjects will be paid/reimbursed for participation? See payment considerations.
Y
11. Funding
Yes/No
• Training Grant?
N
• Program Project Grant?
N
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 7 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

• Federally Sponsored Project?
Y
• Industry Sponsored Clinical Trial?
N
Funding
Funding - Grants/Contracts
Funding Administered By :
VA
SPO # (if available) :
Grant # (if available) :
1 I01 RX002319-01A2
Funded By (include pending) :
Department of
Veterans Affairs
Principal Investigator :
Ansgar J. Furst, PhD
Grant/Contract Title if different from Protocol Title :
Cognitive behavioral therapy for insomnia in chronic traumatic brain injury
Y
For Federal projects, are contents of this protocol consistent with the Federal proposal?
N
Is this a Multiple Project Protocol (MPP)?
N
Is this protocol under a MPP?
Funding - Fellowships
Gift Funding
Dept. Funding
Other Funding
Resources :
a)
Qualified staff.
Please state and justify the number and qualifications of your study staff.
Dr. Furst is the Associate Director of Neuroimaging at the War Related Illness and Injury Study Center
(WRIISC) at VAPAHCS. He is also a Clinical Associate Professor of Psychiatry and Behavioral Sciences
and of Neurology and Neurological Sciences at Stanford University School of Medicine and a research
scientist at the VA Palo Alto Polytrauma System of Care (PSC). He is a co-investigator on several TBI
projects both at the VA and at Stanford University and has extensive experience in the execution of clinical
trials. Dr. Furst is also affiliated with the MIRECC and will oversee the project in its entirety. He will
coordinate between key personnel, study team and consultants. Dr. Furst will also be in charge of writing
progress reports and manuscripts related to the project.
b)
Training.
Describe the training you will provide to ensure that all persons assisting with the research are
informed about the protocol and their research-related duties and functions.
All staff will have completed all VA- and Stanford-required training in Human Subjects, Good Clinical
Practice, Privacy, and HIPAA, and any required training for specific procedures. All staff will be trained in
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

this protocol by the Protocol Director. Some staff have also worked with similar protocols, and all staff
members are very familiar with procedures for this study. Any new staff who join the project will take all
required training before beginning work on the project, and will be carefully trained on all necessary aspects
of the protocol by the Protocol Director or a senior research associate who supervises staff for this project.
Data privacy and proper specimen collection procedures will be stressed before subject contact is allowed.
c)
Facilities.
Provide the location(s) where the research will be conducted, including physical address if not
conducted on site at Stanford University, Stanford Hospital on Pasteur Dr., Lucile Packard Children's
Hospital on Welch Rd. or VAPAHCS. Describe the facilities and resources available to conduct the
research at these sites.
The project will take place at the War Related Illness and Injury Study Center (WRIISC) and the VA
Mental Illness Research, Education, and Clinical Center (MIRECC), located at VA Palo Alto Health Care
System, Palo Alto Division and the Stanford Sleep Disorders Center. Private interview rooms and a large
conference room are available for this project, as well as office space for staff.
Urine and blood samples will be taken and processed by trained staff in the VA Palo Alto Veterans Affairs
Medical Center.
d)
Sufficient time.
Explain the time that you and your research team will allocate to perform the research activities,
including data analysis.
We will have sufficient time to conduct and complete the research. Each of the investigators has sufficient
time available to conduct their part of the research.
Each participant will spend approximately 32 weeks in the project.
We expect to begin recruitment in November, 2018.
We expect project will be completed by the end of 2023.
e)
Access to target population.
Explain and justify whether you will have access to a population that will allow recruitment of the
required number of participants.
We plan to recruit research subjects from the War Related Illness and Injury Study Center (WRIISC) and
the VA Palo Alto Polytrauma System of Care (PSC) and from local clinicians. The WRIISC and PSC
specialize in the care of Traumatic Brain Injury patients and therefore have ample access to this patient
population for recruitment.
f)
Access to resources if needed as a consequence of the research.
State whether you have medical or psychological resources available that participants might require as
a consequence of the research when applicable. Please describe these resources.
The Protocol Director or a senior research associate will provide psychological resources to participants, if
necessary. Appropriate referrals will be made when necessary in the judgment of the physician and/or
psychologist. As the study takes place at the VA Palo Alto medical center, medical assistance is readily
available if needed.
g)
Lead Investigator or Coordinating Institution in Multi-site Study.
Please explain (i) your role in coordinating the studies, (ii) procedures for routine communication with
other sites, (iii) documentation of routine communications with other sites, (iv) planned management of
communication of adverse outcomes, unexpected problems involving risk to participants or others,
protocol modifications or interim findings.
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

1. Purpose
a)
In layperson's language state the purpose of the study in 3-5 sentences.
The purpose of this study is to evaluate the relative efficacy and
effectiveness of Cognitive Behavioral Therapy for Insomnia compared
to an active control condition (Arousal-Based Therapy for Insomnia,
previously referred to as Desensitization Therapy for Insomnia)in
patients with mild Traumatic Brain Injury.
b)
State what the Investigator(s) hope to learn from the study. Include an assessment of the importance of
this new knowledge.
Sleep-wake disturbances are present across the spectrum of TBI
severity and can arise early after injury, during treatment in
hospital, or during inpatient rehabilitation, and often persist for
years after the injury. These problems are particularly prevalent in
cases of mild TBI (mTBI), which represents the majority of cases of
TBI treated in Veterans. Sleep-wake disturbances can exacerbate
other outcomes of TBI, particularly cognitive deficits, pain,
fatigue, and mood disturbances (Orff, Ayalon, & Drummond, 2009;
Ouellet, Beaulieu-Bonneau, & Morin, 2015). In a recent meta-analysis
(Mathias & Alvaro, 2012) roughly 50% of TBI patientswere found to
have sleep disturbances.
VA clinicians have been trained in non-pharmacologic insomnia
treatments. TBI with insomnia (TBI-I) patients are frequently
prescribed sleeping medications with their associated side-effects.
To address the general problem of insomnia in Veterans, over 650 VA
clinicians have been trained between 2012 and 2014 by the VISN 21
MIRECC to provide Cognitive Behavior Therapy for Insomnia (CBT-I), an
evidence-based non-pharmacological insomnia treatment. Although CBT-
I has been suggested to be a compelling treatment alternative in TBI-
I there is not enough conclusive data available to-date to warrant
this claim.
The primary objective of this randomized clinical trial is to assess
the efficacy of CBT-I versus an active control condition, Arousal-
Based Therapy for Insomnia (ABT-I), in TBI-I patients. A secondary
aim is to explore potential baseline moderators of response to CBT-I.
Several baseline characteristics like insomnia severity, "time spend
in bed", cognitive arousal or pain may moderate the treatment
outcome. Knowledge of such moderators would help with
personalizing future therapies and hence improve outcomes.
c)
Explain why human subjects must be used for this project. (i.e. purpose of study is to test efficacy of
investigational device in individuals with specific condition; purpose of study is to examine specific
behavioral traits in humans in classroom or other environment)
This is a study of insomnia in humans who suffered traumatic brain
injury.
2. Study Procedures
a)
Please SUMMARIZE the research procedures, screening through closeout, which the research
participant will undergo. Sections in the protocol attached in section 16 can be referenced, BUT do not
Protocol # 41040 ( Continuing Review )
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APPLICATION FORM
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

copy the clinical protocol. Be clear on what is to be done for research and what is part of standard of
care. For research involving collaborators, please specify the respective roles of Stanford and each
collaborator on the protocol.
SCREENING
Web Screen: Web advertisements will point interested participants to
our study website, which will include a brief web survey to help determine basic eligibility.
More info in section 8i.
Phone Screen:
Respondents will be given a brief description of study procedures and
our research goals. If interested, they will be asked for their
consent for a formal telephone screening interview. Upon receipt of
consent, participants will be interviewed by telephone regarding
their current symptoms and medical histories to determine if we
should proceed to in-person evaluation. With their consent, a review
of their VA medical charts will also be conducted to help confirm
eligibility.
Screening Session:
This evaluation session will last approximately 2-3 hours to perform
relevant psychological tests, and gather medical, psychiatric, and
medication histories. This visit will take place in person or via
Telehealth.
Screening for Obstructive Sleep Apnea and Periodic Limb Movement
Disorder:
The Berlin Questionnaire will be used to screen for sleep apnea
symptoms, and the Duke Structured Interview will be used to screen
for both symptoms of both Obstructive Sleep Apnea and Periodic Limb
Movement Disorder. Participants who are determined to be at high risk
for these disorders will be referred to Pulmonary Medicine for
further evaluation.
Summary Research Team Meeting and Sleep Disorders Diagnosis:
Before a subject will be entered into the treatment, the summary
research team will review all aspects of the case to determine
ultimate eligibility. All evidence collected during the screening
will be used to develop formal sleep disorders diagnoses.
BASELINE
Two Weeks of Baseline Sleep Logs:
At the end of the first screening session, participants
will be shown how to complete daily sleep logs for the duration of
the study to provide subjective sleep data. We will use a modified
Consensus Sleep Diary-E for our sleep log. Sleep logs will be
returned to us during in person visits, or via MyHealtheVet.
Baseline Evaluation:
In this session subjects will complete psychological evaluations.
Cognitive testing will be administered on paper and using the CANTAB
Connect Research software via iPad. A blood sample will be collected
at this visit.
Optional Polysomnography (PSG):
Participants who agree will be set up with a Compumedics Siesta
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Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

ambulatory overnight PSG recording at the end of their baseline
evaluation. Participants will then return home to sleep, and return
the next morning to provide urine and blood samples. VA approved taxi and hotel service may be offered
for those traveling long distances or
who don't have a ride to and from the VA for the PSG.
Blood and Urine samples:
Urine samples will be collected at baseline, eight-week and six-month
visits for all participants. Urine samples will be screened by the
PAVAHCS laboratory for several exclusionary medications and drugs,
and results will be uploaded to the participant's secure medical file.
A total of two blood samples will be drawn over the course of the
study - once at baseline and once after treatment has been completed.
A trained, experienced nurse or phlebotomist will draw the blood.
These blood samples will be processed by the VA laboratory to test
for inflammatory markers, and the results will be uploaded to the
participant's secure medical file. If they consent to storage of
blood samples, the samples will later be used to examine genetic
material.
If we are unable to complete labwork, overnight PSG or in-person
cognitive tests due to VA restrictions or participant refusal as a
result of COVID-19 concerns, we will not exclude these participants
from the study.
TREATMENT
Our hypotheses will be tested in a randomized parallel groups design.
Randomization will be based on type of treatment assignment: either
to Cognitive Behavior Therapy for Insomnia (CBT-I) or Arousal-Based
Therapy for Insomnia (ABT-I)(previously referred to as
Desensitization Therapy for Insomnia) for the 6-week treatment phase.
CBT-I (SR & CT):
The CBT-I adopted in this trial will be based on our large-scale VA
implementation of CBT-I and includes a published sleep self-help
book, a published therapist guide, and the CBT-I therapist manual
appended. It comprises both SR and CT as outlined below. The CBT-I
therapy protocol consists of six sessions (an initial assessment and
five treatment sessions). Treatment begins with a comprehensive sleep
assessment and case conceptualization, which are used to guide
selection and sequencing of CBT-I components. Treatment components
include stimulus control, sleep restriction therapy, relaxation, and
cognitive therapy. The final session focuses on maintenance of gains
and relapse prevention.
Sleep Restriction Therapy (SR). The initial Time in Bed (TIB)
prescription is calculated on the average total sleep time (TST)
reported by subjects in their baseline sleep logs. Subsequently, the
TIB prescription is determined using the formula: TIB = average TST.
An additional treatment criterion is that prescribed initial time in
bed should never be below 5 hours, even if the average total sleep
time (TST) is very low (e.g., 3 hours). After one week, depending on
subject's daily sleep logs and discussion with participant about
tolerability, the therapist suggests a new TIB prescription. The
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Review Type: Regular
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Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

initial TIB, retiring times and wake times are set with subject input
to ensure tolerability. Daytime sleep will not be manipulated in SR
treatment. Napping is neither prescribed nor proscribed. However, if
subjects find themselves very sleepy (not just tired, but actually
sleepy) they are advised to take a brief (15 to 30 minutes) nap to
ensure their safety. These safety naps can be taken at any time
because safety is always the most important consideration. Subjects
are given additional rationale for the treatment constraints and
suggestions for dealing with any difficulties they have in complying
with their prescribed sleep schedules. Information on relevant
elements of the science of sleep is included in explaining how the
treatment works.
Cognitive Therapy (CT). The CT treatment module is designed to meet
three general goals: 1) identification of dysfunctional sleep
cognitions, 2) challenging their validity, and 3) replacing them with
more adaptive substitutes. Several specific techniques designed to
meet these goals are discussed in materials distributed to subjects.
Systematic self-monitoring for identifying dysfunctional sleep
cognitions will be a basic component of the treatment. Replacing
inaccurate thoughts through cognitive restructuring involves the
identification, evaluation, and modification of maladaptive thoughts.
In the context of insomnia, the focus is on sleep-related thoughts
that increase arousal, and therefore directly interfere with sleep.
Basic concepts about CBT for chronic pain are included in training,
for example, directly addressing hopelessness in relation to chronic
pain that may interfere with sleep. Once sleep-incompatible thoughts
are identified, dysfunctional ideas about the causes and consequences
of insomnia and unreasonable expectations about normal sleep can be
challenged in a nonjudgmental manner using scientifically based
information about sleep and replacing them with more adaptive
conceptions. Similar to SR, subjects in CT are given information
about relevant elements of the science of sleep and healthy sleep
practices.
Arousal-Based Therapy for Insomnia (ABT-I):
The subjects assigned to the "Credible Control Therapy for Insomnia"
(ABT-I) condition will receive a quasi-desensitization treatment
presented as a means of eliminating the "conditioned arousal," which
prolongs nocturnal awakenings. Therapists help each ABT-I recipient
develop a chronological 8-item hierarchy of common activities he/she
does on awakening at night (eg, opening eyes, clock watching).
Therapists also help them develop 6 imaginal scenes of themselves
engaged in neutral activities (e.g., reading the newspaper). Each
session, ABT-I recipients are taught to pair neutral scenes with
items on the 8-item hierarchy so, by the end of the sixth session,
all hierarchy items have been practiced with therapist assistance.
Each session, the exercise is tape recorded and the patient is given
this tape locked in a player. The patients are told to practice their
exercises at home once each day, no less than 2 hours before bedtime,
but to avoid using the tape or exercise during sleep periods.
We will offer participants the option of completing therapy sessions
via Telehealth and will aim to complete all treatment sessions via
their chosen modality. If a participant needs to switch modalities
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Page 13 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

due to unforeseen circumstances (e.g. illness) we will accommodate
this request.
FOLLOW UP
The complete package of outcome measures (including optional
ambulatory PSG) will be repeated at the week 8 and six-month follow-up sessions.
We will tell subjects that we expect the benefits of treatment to
continue and/or improve with time and we will also encourage subjects to continue practicing the treatment
instructions to maintain their
progress.
b)
Explain how the above research procedures are the least risky that can be performed consistent with
sound research design.
There is little risk to the proposed procedures.
c)
State if deception will be used. If so, provide the rationale and describe debriefing procedures. Since
you will not be fully informing the participant in your consent process and form, complete an
alteration of consent (in section 13). Submit a debriefing script (in section 16).
N/A
d)
State if photo, audio or video recording will occur. Describe what will become of the photos or
recording after use, e.g., shown at scientific meetings, erased. Describe the final disposition of the
recordings.
No video recordings will be used. Audio recordings will be made of
the therapy sessions for quality control purposes. After the results
of the study are analyzed the tapes will be stored according to VA
requirements.
e)
Describe alternative procedures or courses of treatment, if any, that might be advantageous to the
participant. Describe potential risks and benefits associated with these. Any standard treatment that is
being withheld must be disclosed in the consent process and form. (i.e. standard-of-care drug, different
interventional procedure, no procedure or treatment, palliative care, other research studies).
Alternate treatments for insomnia include various medications and
other behavioral treatments. An alternative is not to participate.
f)
Will it be possible to continue the more (most) appropriate therapy for the participant(s) after the
conclusion of the study?
The study treatments are forms of learning or training. Participants
should be able to continue on their own if they find the treatment
useful. They will be given didactic material that they can refer to
after the treatment is over. In the case of the ABT-I(placebo) arm we
will provide them with an introduction to CBT-I and contacts to
pursue this treatment option.
g)
Study Endpoint. What are the guidelines or end points by which you can evaluate the different
treatments (i.e. study drug, device, procedure) during the study? If one proves to be clearly more
effective than another (or others) during the course of a study, will the study be terminated before the
projected total participant population has been enrolled? When will the study end if no important
differences are detected?
The study is expected to continue until all participants have
completed the procedures.
3. Background
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

a)
Describe past experimental and/or clinical findings leading to the formulation of the study.
For more than twenty years we have investigated the efficacy of a
broad range of non-drug treatments for older adults with insomnia,
comparing relaxation versus sleep restriction, sleep restriction
versus sleep hygiene, and bright light versus sleep hygiene. We also
initiated the development of a large-scale implementation of a
package of cognitive behavioral therapies for insomnia (CBT-I) in the
VA Health Care system. Increasingly, the field has moved toward using
a combination of various non-drug treatments. The combination
therapies all share a cognitive therapy (CT) component that focuses
on techniques such as systematic self-monitoring for identifying
dysfunctional sleep cognitions. In addition, the combination
therapies include diverse behavioral components such as sleep
restriction (SR), relaxation, stimulus control, and sleep hygiene.
The field has progressed to where the next stage of treatment
development should move towards:
1) disaggregating the relative clinical impact of specific CBT-I
components, and
2) identification of the mechanisms of action (mediators) and
individual differences in response (moderators) of that effect to
enable more efficient, effective, and acceptable delivery of CBT-I.
b)
Describe any animal experimentation and findings leading to the formulation of the study.
Not applicable.
4. Radioisotopes or Radiation Machines
a)
List all standard of care procedures using ionizing radiation (radiation dose received by a subject that
is considered part of their normal medical care). List all research procedures using ionizing radiation
(procedures performed due to participation in this study that is not considered part of their normal
medical care). List each potential procedure in the sequence that it would normally occur during the
entire study. More Info
Identify Week/Month of study
Name of Exam
Identify if SOC or Research
b)
For research radioisotope projects, provide the following radiation-related information:
Identify the radionuclide(s) and chemical form(s).
For the typical subject, provide the total number of times the radioisotope and activity will be
administered (mCi) and the route of administration.
If not FDA approved provide dosimetry information and reference the source documents (package
insert, MIRD calculation, peer reviewed literature).
c)
For research radiation machine projects, provide the following diagnostic procedures:
For well-established radiographic procedures describe the exam.
For the typical subject, identify the total number of times each will be performed on a single
research subject.
For each radiographic procedure, provide the setup and technique sufficient to permit research
subject dose modeling. The chief technologist can usually provide this information.
For radiographic procedures not well-established, provide FDA status of the machine, and
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Review Type: Regular
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Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
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information sufficient to permit research subject dose modeling.
d)
For research radiation machine projects, provide the following therapeutic procedures:
For a well-established therapeutic procedure, identify the area treated, dose per fraction and
number of fractions. State whether the therapeutic procedure is being performed as a normal part of
clinical management for the research participants's medical condition or whether it is being
performed because the research participant is participating in this project.
For a therapeutic procedure that is not well-established, provide FDA status of the machine, basis
for dosimetry, area treated, dose per fraction and number of fractions.
5. Devices
a) Please list in the table below all Investigational Devices (including Commercial Devices used off-label) if
they are being studied.
b) Please list in the table below all IDE Exempt Devices (Commercial Device used according to label,
Investigational In Vitro Device or Assay, or Consumer Preference/Modifications/Combinations of
Approved Devices) to be used on participants.
6. Drugs, Reagents, or Chemicals and Devices
a) Please list in the table below all investigational drugs, reagents or chemicals if they are being studied.
b) Please list in the table below all commercial drugs, reagents or chemicals if they are being studied.
7. Medical Equipment for Human Subjects and Laboratory Animals
If medical equipment used for human patients/participants is also used on animals, describe such
equipment and disinfection procedures.
No medical equipment used with the human participants is also used on animals.
8. Participant Population
a)
State the following: (i) the number of participants expected to be enrolled at Stanford-affiliated site(s);
(ii)the total number of participants expected to enroll at all sites; (iii) the type of participants (i.e.
students, patients with certain cancer, patients with certain cardiac condition) and the reasons for
using such participants.
(i) We plan to enroll 120 participants at the VA Palo Alto Health Care Systems, a Stanford-affiliated site.
(ii) This is the only site for this project.
(iii) All participants will have a sleep/wake disturbance as defined in the Inclusion/Exclusion criteria.
b)
State the age range, gender, and ethnic background of the participant population being recruited.
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

Age Range: 21 years old and older
Gender: Males and Females
Ethnic Background: Any race or ethnic origin
c)
State the number and rationale for involvement of potentially vulnerable subjects in the study
(including children, pregnant women, economically and educationally disadvantaged, decisionally
impaired, homeless people, employees and students). Specify the measures being taken to minimize the
risks and the chance of harm to the potentially vulnerable subjects and the additional safeguards that
have been included in the protocol to protect their rights and welfare.
Children and pregnant women will not be recruited for this protocol.
d)
If women, minorities, non-English speaking individuals, or children are not included, a clear
compelling rationale must be provided (e.g., disease does not occur in children, drug or device would
interfere with normal growth and development, etc.).
There will be no participation of children in this study. The research topic to be studied is irrelevant to
children because we are studying the effects of insomnia in adults.
e)
State the number, if any, of participants who are laboratory personnel, employees, and/or students.
They should render the same written informed consent. If payment is allowed, they should also receive
it. Please see Stanford University policy.
It is unlikely that any laboratory personnel, employees, or students will qualify for participation in this
study. If any do qualify and wish to participate, they will be treated the same as any other participant.
f)
State the number, if any, of participants who are healthy volunteers. Provide rationale for the
inclusion of healthy volunteers in this study. Specify any risks to which participants may possibly be
exposed. Specify the measures being taken to minimize the risks and the chance of harm to the
volunteers and the additional safeguards that have been included in the protocol to protect their rights
and welfare.
Participants should all be in fair to good physical health. We are excluding any health problems likely to
exacerbate sleep problems. Risks are minimal; it is possible that patients may experience transient
deterioration of sleep during the treatment, but this should improve if the participant follows the assigned
protocol. Participants can contact study staff for assistance if they feel their insomnia is getting worse.
g)
Describe your plan to identify and recruit potential participants including who will inform them about
the study and how they will be initially contacted by the researchers (e.g., Research Engagement
services; chart review; treating physician; ads including social media posts). All final or revised
recruitment materials must be approved by the IRB before use. Contacting potential participants is
not permitted prior to IRB approval. See Recruitment Guidance for additional information.
Veterans will be recruited at the VA Palo Alto WRIISC and PSC that are the normal clinical referral sources
for TBI patients. We will also do chart reviews of Palo Alto VA patients recently seen for TBI/insomnia
complaints and reach out to them with an letter introducing our study, followed by a phone call. Veterans
may also be recruited from ClinicalTrials.gov. We will circulate flyers on VA campuses and around the Bay
Area, and reach out to non-VA veteran groups and communities with flyers and brochures. We will also
post newspaper ads and online ads on sites such as Facebook, StudyPages and Craigslist for interested
participants across the US to recruit participants for Telehealth therapy.
We will be accessing participant databases provided to us by other principal investigators at the Palo Alto
VA to identify potential participants for our study, in accordance with VA policies. These will be
participants who have been screened or contacted by other research groups and have consented to be
contacted for research opportunities. Letters will be sent to these Veterans, cosigned by the original
principal investigator, with information about our current study and pre-paid response envelopes. Follow up
phone calls will be made within 2 weeks after letters have been sent out.
If any VA provider notes a recent patient of theirs may be eligible for our study, we will send an
introductory letter to the patient co-signed by the provider with information about our study. Alternately,
providers who receive verbal consent from the participant to be contacted by us may leave a note in the
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

patient's CPRS medical record and co-sign a study coordinator, at which point we will reach out to the
veteran directly. These methods are consistent with VA privacy guidelines.
We will also submit a DART (The Data Access Request Tracker Application) request to filter and access
VA medical records based on diagnosis.
We will submit a DMDC (Defense Manpower Data Center) Request to receive contact information for
retired military personnel within a 50 mile radius.
We have created a website through the Stanford School of Medicine to advertise the study and provide
information for prospective participants and also for the general public:
http://med.stanford.edu/sleepless-warriors.html
A pre-screen survey with basic eligibility questions will be hosted on Stanford's Redcap or StudyPages and
uploaded to the study's website. Web advertisements will point to this page so interested members of the
public can fill it out to determine their eligibility. If the survey determines they may be eligible for the
study, the last page will prompt them to enter their name and phone number to be contacted by us.
h)
Inclusion and Exclusion Criteria.
Identify inclusion criteria.
- Male or female Veterans of any racial or ethnic group
- Independent Living (not in nursing home or VA Extended Care facility)
- Diagnosis of insomnia using the Duke structured interview
- Male or female chronic (>3 months since injury) mild Traumatic Brain Injury (mTBI).
- Subjects with PTSD will be included in this study as long as they do not meet criteria for depression
described below.
- Use of CNS active medications that could significantly impact sleep or alertness is allowed as long as the
dose, timing, and formulation are stable (≥3 weeks).
- Stable adult onset diabetes, controlled with insulin, oral medications or diet is acceptable.
- Use of medications, drugs, herbal remedies, or hormones specifically prescribed for treating sleep
disturbances is allowed as long as the dose, timing, and formulation are stable (≥3 weeks).
- Subjects will be assessed for sleep apnea risk by the Berlin Questionnaire. Those with responses
suggestive of high risk for apnea will be referred to Pulmonary Medicine for standard clinical screening, but
will not be excluded. If subjects with obstructive sleep apnea are using CPAP, we will require stable use
throughout the study.
Identify exclusion criteria.
Sleep-Related
- Excessive caffeine consumption (≥5 cups of coffee per day) and unable to reduce to ≤3 cups before lunch
a day for ≥3 weeks prior to treatment.
- Subjects working a rotating shift or an unconventional daytime shift (ending after 1700 h, expected to be
rare in the age group we are studying) will be ineligible.
Neuropsychiatric
- Current or lifetime history of a psychiatric disorder with primary psychotic features.
- Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation.
- Current or within the past 30 days: drug abuse or dependence (except nicotine).
- Current or expected cognitive behavior therapy for another condition (e.g. depression).
- More than one glass of wine or beer with dinner scheduled at least 3 to 4 hours before bedtime.
- Presence of any acute or unstable psychiatric condition(s) that requires referral for treatment.
- Folstein Mini-Mental State Exam (MMSE) < 24.
Medical
- Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney,
prostate or bladder conditions causing excessively frequent urination (> 3 times per night); medically
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PD: Ansgar Furst
APPLICATION FORM
Page 18 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen
changes in the prior 3 months; stroke with serious sequelae; cancer if < 1 year since end of treatment;
asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological
disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment
regimen changes in the prior 3 months. Unstable adult onset diabetes will be excluded.
i)
Describe your screening procedures, including how qualifying laboratory values will be obtained. If
you are collecting personal health information prior to enrollment (e.g., telephone screening), please
request a waiver of authorization for recruitment (in section 15).
Web advertisements for Telehealth participation will point participants to our study website and a
pre-screening questionnaire hosted on Stanford Redcap and embedded in our website (attached in section
16).
Alternately, the company StudyPages will manage these advertising campaigns, and will set up a separate
site and pre-screen questionnaire (attached in section 16). The StudyPages site and
questionnaire is hosted by them, and privacy/security is addressed in section 9c.
Subjects will be screened for eligibility via a phone interview and an in-person or Telehealth evaluation.
During the phone screen, respondents will be given a brief description of study procedures and research
goals. If respondents are interested, the interviewer will ask further questions regarding current symptoms
and medical histories to determine if we should proceed to an in-person screening evaluation. We will also
request permission from the participant to review their VA medical chart to obtain further relevant
information.
At the in-person or Telehealth evaluation, after reviewing the consent form and providing verbal consent, a
more detailed assessment about sleep problems, and medical and psychiatric history will be completed.
Insomnia will be diagnosed using the Duke Structured Sleep Interview using DSM 5 criteria, and other
sleep disorders will be screened for using DSM-IV criteria in the same interview. A medication list,
Acute/Unstable Illness checklist and chart review will be used to screen for acute/unstable medical illness.
The Mini Mental State Exam (MMSE) will be used to assess cognitive impairment. Mild TBI (mTBI) will
be confirmed using the Boston Assessment of Traumatic Brain Injury – Lifetime (BAT-L).
Psychiatric criteria will be assessed using the Mini International Neuropsychiatric Interview Version 7
(MINI). Participants who show risk for suicidality will be assessed with the Columbia Suicide Severity
Rating Scale (C-SSRS). Subjects taking sleeping medications at the time of recruitment will be admitted to
the study if under the supervision of their physician they remain stable on the medication for a minimum of
3 weeks before acceptance into the protocol.
j)
Describe how you will be cognizant of other protocols in which participants might be enrolled. Please
explain if participants will be enrolled in more than one study.
We will ask the potential subject if they are participating in any other protocols on the consent form. They
will be instructed not to participate in any other protocols during their involvement with our study without
first getting prior authorization from both our research team and that of the other study. Overlapping
participation will be handled on a case-by-case basis.
k)
Payment/reimbursement. Explain the amount and schedule of payment or reimbursement, if any, that
will be paid for participation in the study. Substantiate that proposed payments are reasonable and
commensurate with the expected contributions of participants and that they do not constitute undue
pressure on participants to volunteer for the research study. Include provisions for prorating payment.
See payment considerations
Payment of $325 will be provided for all participants who complete the study, including those participating
solely via Telehealth. A further $150 will be provided to in-person participants who agree to the three
overnight sleep studies and subsequent urine screens.
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

Participants will receive:
$25 for the screening procedures
$50 for the baseline visit, and a further $50 if they choose to participate in the overnight sleep study &
blood/urine test.
$25 for each of the 6 treatment visits.
$50 for the end-of-treatment visit, and a further $50 if they choose to participate in the overnight sleep study
& urine test.
$50 for the 6-month follow up visit, and a further $50 if they choose to participate in the overnight sleep
study & blood/urine test.
In-personarticipants will receive $10 VA canteen lunch vouchers for the longer screening, baseline and
follow up visits.
If it is necessary for a participant to terminate before the end of follow-up because of the return of
symptoms, they will be paid for the portion of the study they have completed.
We feel this is a reasonable amount in light of the time and effort the participant will spend in the study. The
amount of this payment is similar to that paid for by other labs conducting similar studies.
l)
Costs. Please explain any costs that will be charged to the participant.
No costs to the subject will arise as a result of participation in this study, other than transportation to and
from the Center, and the time involved.
m)
Estimate the probable duration of the entire study. Also estimate the total time per participant for: (i)
screening of participant; (ii) active participation in study; (iii) analysis of participant data.
The entire study should take 4 years.
(i) Screening for each participant will take approximately 2-3 hours
(ii) Each participant will actively participate in the study for approximately 32 weeks.
(iii) Analysis of participant data is estimated to take about 6-12 months.
9. Risks
a) For the following categories include a scientific estimate of the frequency, severity, and reversibility of potential
risks. Wherever possible, include statistical incidence of complications and the mortality rate of proposed
procedures. Where there has been insufficient time to accumulate significant data on risk, a statement to this
effect should be included. (In describing these risks in the consent form to the participant it is helpful to use
comparisons which are meaningful to persons unfamiliar with medical terminology.)
i. The risks of the Investigational devices.
Not applicable.
ii. The risks of the Investigational drugs. Information about risks can often be found in the
Investigator's brochure.
Not applicable.
iii. The risks of the Commercially available drugs, reagents or chemicals. Information about risks can
often be found in the package insert.
Not applicable.
iv. The risks of the Procedures to be performed. Include all investigational, non-investigational and
non-invasive procedures (e.g., surgery, blood draws, treadmill tests).
Cognitive testing.
There are virtually no risks involved in the cognitive testing and psychosocial measurements other than the
anxiety that can be associated with any test. Repeated evaluations of mood and mental status may be
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Review Type: Regular
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Stanford University
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Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

slightly frustrating or produce fatigue and boredom.
Sleep Log and Questionnaires.
There are no harmful effects to filling out the sleep log and questionnaires, but some people may find
answering the questionnaires annoying or boring.
Urine testing.
Urine testing involves no risk other than the bother involved.
EEG recording.
There is little risk to EEG recording. Participants may find the cap annoying or uncomfortable. If this
occurs we will try to make them more comfortable, or stop the procedure if the participant requests.
Venipuncture.
Removal of blood by a needle and syringe poses a small risk of pain or bruising at the site of the needle
stick, but this is temporary. Some people may experience fainting or dizziness, and there is also a slight risk
of infection at the site of the needle stick.
Sleep treatments. It is possible that participants may become very sleepy under the Sleep Restriction part of
the treatments. If this occurs, they will be advised to avoid driving, operating machinery, or doing activities
that require close attention for the first few days of therapy.
v. The risks of the Radioisotopes/radiation-producing machines (e.g., X-rays, CT scans, fluoroscopy)
and associated risks.
Not applicable.
vi. The risks of the Physical well-being.
See above procedures. No other risks to physical well-being are anticipated.
vii. The risks of the Psychological well-being.
From past experience, potential risk to participants is expected to be minimal. Specifically, questions asked
that may be potentially distressing to the participants or may cause them to think about problems relating to
them that may be anxiety-provoking or upsetting.
A psychiatric screening will be performed to determine whether the participant meets inclusion and
exclusion criteria for the study. From past experience, potential risk to participants is expected to be
minimal. Specifically, questions asked may be potentially distressing to the participants or may cause them
to think about problems relating to them that may be anxiety-provoking or upsetting. Patients who develop
suicidal intent will be treated following established procedures at VAPAHCS.
Cognitive Testing.
There do not appear to be any risks associated with cognitive testing other than the commitment of
significant time for participation. Some participants may experience anxiety during and after the cognitive
testing.
Questionnaires.
There are virtually no risks involved in filling out our questionnaires, sleep-wake cycle questionnaires and
sleep logs other than the time involved.
viii. The risks of the Economic well-being.
No risks to economic well-being are anticipated.
ix. The risks of the Social well-being.
No risks to social well-being are anticipated.
Overall evaluation of Risk.
Low - innocuous procedures such as phlebotomy, urine or stool collection, no therapeutic agent, or safe
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therapeutic agent such as the use of an FDA approved drug or device.
b)
If you are conducting international research, describe the qualifications/preparations that enable you
to both estimate and minimize risks to participants. Provide an explanation as to why the research
must be completed at this location and complete the
[LINKFORINTERNATIONALREASEARCHFORM] International Research Form. If not applicable,
enter N/A.
Not applicable.
c)
Describe the planned procedures for protecting against and minimizing all potential risks. Include the
means for monitoring to detect hazards to the participant (and/or to a potential fetus if applicable).
Include steps to minimize risks to the confidentiality of identifiable information.
Suicidal thoughts.
At the prescreen web survey we will ask "Did you repeatedly think about death, or have any thoughts of
killing yourself, or have any intent or plan to kill yourself? Did you attempt suicide?" and include the
statement "If you have had any thoughts of hurting yourself, please contact the Veterans crisis line" with
corresponding info. At face-to-face screen, we will ask the same question and if the answer is positive, we
will provide the participant's information to the Veteran's crisis line so they can follow up & determine risk.
Cognitive testing.
If the participant is fatigued or uncomfortable with testing, a break can be taken to rest. If a participant is
unwilling to continue a testing session, they will be given the option of continuing at a later time, ending the
current session, or ending all participation.
PSG and EEG.
We will make every attempt to attach sensors carefully so that they provide the minimum discomfort
possible.
Data.
Paper data with PHI will be kept in locked cabinets and electronic data with PHI will be stored on
physically secure and password protected computers and on the MIRECC/WRIISC server in the VAPAHCS
server room (a locked facility behind the VA firewall). Computer data backups are done by VA IT.
Computers are password protected. Offices are locked when unoccupied. All e-mails, texts and other
unencrypted forms of communication will not involve PHI.
Sleep Log and Questionnaires.
There are no known significant risks associated with completing Sleep Logs and associated questionnaires.
Telehealth
Any study appointment conducted via Telehealth will use VA Video Connect
(https://mobile.va.gov/app/va-video-connect), a program used by VA clinical and research staff. It is
encrypted, and the video will be locked to anyone other than the provider and the participant. Both the study
therapist and participant will use the software in a private room to ensure confidentiality. Video will not be
recorded.
Invite links to Telehealth sessions will be sent to the participant via email. Participants will be able to access
Telehealth via their own personal computers, or via a VA-encrypted iPad provided by the study.
Pre-screen surveys using Redcap and StudyPages
REDCap (Research Electronic Data Capture) is an application for building and managing online databases.
The Stanford Center for Clinical Informatics (SSCI) runs and supports a secure, local Stanford installation
of REDCap for the Stanford research community at no cost. REDCap provides a web-based interface for
collecting data with data validation and includes the ability for automated export to statistical packages. The
software also includes data logging for HIPAA compliance and the ability for administrators to define
access rights on a per-user basis. Data stored in production REDCap databases is not automatically purged,
but archiving of completed projects within REDCap is recommended. In the event the REDCap service
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Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

were to be replaced or discontinued, all project owners would be notified and plan devised that would allow
ample time for owners to export their data.
StudyPages is HIPAA compliant. It is hosted and managed on Amazon Web Services (AWS), a highly
scalable cloud computing platform with end-to-end security and privacy features built in. All StudyPages
research staff are required to login using email/password. Only study team members with access to a study
workspace can view signup details (name, email, phone number, etc.) for that study. To protect sensitive
information, data at rest is encrypted with 256-bit AES encryption in the StudyPages Application Database.
All data transfer in/out of the system is encrypted in-transit using 256 bit SSL and all communications with
the StudyPages platform are forced to use HTTPS.
d)
Explain the point at which the experiment will terminate. If appropriate, include the standards for the
termination of the participation of the individual participant Also discuss plans for ensuring necessary
medical or professional intervention in the event of adverse effects to the participants.
The experiment will end at either the normal termination or whenever the subject decides to withdraw from
the study.
e)
Data Safety and Monitoring Plan (DSMP). See guidance on Data Safety and Monitoring.
A Data and Safety Monitoring Plan (DSMP) is required for studies that present Medium or High risk
to participants. (See Overall Evaluation of Risk above). If Low Risk, a DSMP may not be necessary.
Multi-site Phase III clinical trials funded by NIH require the DSM Plan to have a Data Safety
Monitoring Board or Committee (DSMC or DSMB). The FDA recommends that all multi-site clinical
trials that involve interventions that have potential for greater than minimal risk to study participants
also have a DSMB or DSMC.
The role of the DSMC or DSMB is to ensure the safety of participants by analyzing pooled data from
all sites, and to oversee the validity and integrity of the data. Depending on the degree of risk and the
complexity of the protocol, monitoring may be performed by an independent committee, a board
(DSMC/DSMB), a sponsor's Data Safety Committee (DSC), a Medical Monitor, a sponsor's safety
officer, or by the Protocol Director (PD).
Describe the following:
1. What type of data and/or events will be reviewed under the monitoring plan, e.g. adverse events,
protocol deviations, aggregate data?
At each visit, participants will be asked about any adverse events which may have occurred since the last
visit. Information about adverse events (including any injuries, illnesses, hospitalizations, etc.; this
would include any adverse effects on sleep caused by study procedures) is collected at each visit by the
interviewer. Any potentially serious problem is brought immediately to the Principal Investigator for
review.
2. Identify who will be responsible for Data and Safety Monitoring for this study, e.g. Stanford
Cancer Institute DSMC, an independent monitoring committee, the sponsor, Stanford investigators
independent of the study, the PD, or other person(s).
The Protocol Director is the monitoring entity.
3. Provide the scope and composition of the monitoring board, committee, or safety monitor, e.g.,
information about each member's relevant experience or area of expertise. If the Monitor is the
Stanford Cancer Center DSMC or the PD, enter N/A.
n/a
4. Confirm that you will report Serious Adverse Events (SAEs), Suspected Unexpected Serious
Adverse Reactions (SUSARs), or Unanticipated Problems (UPs) to the person or committee
monitoring the study in accordance with Sponsor requirements and FDA regulations.
The Protocol Director will review all Adverse Events and Serious Adverse Events as soon as possible
after the occurrence. SAEs are reported and forwarded to IRB as appropriate.
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 23 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

5. If applicable, how frequently will the Monitoring Committee meet? Will the Monitoring
Committee provide written recommendations about continuing the study to the Sponsor and IRB?
Information about adverse events is collected at each visit by the interviewer. Any potentially serious
problem is brought immediately to the Protocol Director. All data entered into the database is monitored
by the senior research associate and the database manager.
6. Specify triggers or stopping rules that will dictate when the study will end, or when some action
is required. If you specified this in Section 2g [Study Endpoints], earlier in this application enter
'See 2g'.
Criteria for discontinuation of a patient in the study will include an increase in bothersome nightmares
for a week under treatment. We have not seen consistent reporting of nightmares with the proposed
treatments, however that is always possible, hence again we would want to make sure that that occurred
for at least a week before a patient was discontinued. Patients will be allowed to continue in the protocol
after an SAE independent of treatment, e.g. hospitalization following a fall. All treatments are
considered active and patients will be allowed to continue their treatment as a courtesy. However, data
from such subjects will not be included in statistical analyses since such SAEs may affect sleep. Patients
will not be restarted if their sleep deteriorates meeting the above criteria and they are discontinued from
the protocol.
7. Indicate to whom the data and safety monitoring person, board, or committee will disseminate
the outcome of the review(s), e.g., to the IRB, the study sponsor, the investigator, or other officials,
as appropriate.
Serious Adverse Events are reported to the IRB using the standard reporting forms.
8. Select One:
Y
The Protocol Director will be the only monitoring entity for this study.
This protocol will utilize a board, committee, or safety monitor as identified in question #2 above.
10. Benefits
a)
Describe the potential benefit(s) to be gained by the participants or by the acquisition of important
knowledge which may benefit future participants, etc.
Some participants may find that their sleep is improved.
11. Privacy and Confidentiality
Privacy Protections
a)
Describe the setting and method (e.g. crowded waiting room, patient exam room, telephone or email
communication) in which interactions will occur and how the privacy interests of participants will be
maintained. Note, high risk data such as PHI must be sent via "Secure:" email per Stanford policy.
During screening, participants will meet in a private interview room
or via a private Telehealth session with a member of the study team
to sign the consent form, discuss the protocol, and determine suitability for enrollment. All interviews and
treatment sessions will be done in a private setting. Samples will be obtained in a private setting.
With the participants consent, short email or text message
communications without PHI/PII will be sent as appointment reminders,
per VA privacy guidelines.
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 24 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

With the participants consent, MyHealtheVet secure messaging will be
used by registered and trained research personnel. This is a portal
approved by the VA for secure messaging of PHI/PII in by clinicians
and research staff. Communication through regular USPS mail will be
presented as an alternative.
Confidentiality Protections
b)
Specify PHI (Protected Health Information). PHI is health information linked to HIPAA identifiers
(see above). List BOTH health information AND HIPAA identifiers. If you are using STARR, use the
Data Privacy Attestation to ensure that your request will match your IRB-approved protocol. Be
consistent with information entered in section 15a.
We are collecting the following identifiable information or PHI:
* full name,
* social security number (for VA hospital registration and payment),
* telephone number (for communication),
* mailing address (for appointment notices and to mail payment),
* date of birth (study metric),
* date of visit,
* VA CPRS medical record
* Medical history and physical examination information,
* Demographic information (gender, ethnicity, education, occupation)
* Progress notes,
* Biological specimens (e.g. blood, urine, spinal fluid),
* Diagnostic/Laboratory test results,
* Discharge summary,
* Survey/Questionnaire responses,
* Cognitive and Psychological test results.
c)
You are required to comply with University Policy that states that ALL electronic devices: computers
(laptops and desktops; OFFICE or HOME); smart phones; tablets; external hard disks, USB drives,
etc. that may hold identifiable participant data will be password protected, backed up, and encrypted.
Stanford University IT approved platforms (https://uit.stanford.edu/guide/riskclassifications
https://uit.stanford.edu/guide/riskclassifications) should be used for data management. Consult with
your Department IT representative for more information.For data security policies and links to
encrypt your devices see http://med.stanford.edu/irt/security and
target=_blankhttp://www.stanford.edu/group/security/securecomputing/mobile_devices.html.
Additionally, any PHI data on paper must be secured in a locked environment.
By checking this box, You affirm the aforementioned. Y
Paper data / PHI will be kept in locked file cabinets and electronic
data with PHI will be stored on physically secure and password
protected computer servers behind a firewall at the VAPAHCS.
Computer data backups will be stored in locked cabinets. Computers
will be password protected. Laptops, cell phones and removable hard
drives will be encrypted. The WRIISC is located in a lockable area of
Building 5 at the VAPAHCS. Offices are locked when not occupied.
All samples are stored in a locked laboratory at VAPAHCS. De-
identified data are stored internally and are off-loaded to a PC via
a USB cable. Some questionnaires will be administered via computer
using REDcap behind the VA firewall. The CANTAB cognitive test data
will be collected via password-protected iPad with participants
identified only by their study code. No PHI will be transmitted by
the CANTAB program.
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 25 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

All contact with participants will be encrypted if PHI is to be
disclosed.
The study therapist will conduct Telehealth via a VA encrypted VA
Video Connect software on a VA issued desktop or laptop.
Participants will use their personal computers or study provided
iPads in a private location. No PHI will be entered during their use
of the device.
Survey data collected via Stanford's Redcap site will include PHI.
Links to these surveys will be sent to participants via their secure
MyHealtheVet messaging portal, where they will click the link to
access the surveys. Surveys responses will only be associated with
the participant's study ID. Their name, contact info and some demographics will be collected.
Data storage on VA's Redcap will not include any PII including no names, contact information
or
identifiable demographic information.
The VA Video Connect telehealth program is encrypted and secure and will be the main
method
of conducting Telehealth appointments with participants.
Zoom, FaceTime, or Skype will be used temporarily in accordance with
VA recommendations during the COVID-19 outbreak with participants
consent.
d)
Describe how data or specimens will be labeled (e.g. name, medical record number, study number,
linked coding system) or de-identified. If you are de-identifying data or specimens, who will be
responsible for the de-identification? If x-rays or other digital images are used, explain how and by
whom the images will be de-identified.
Data, specimens, and computer files will be given a code and
information linking code and PHI will be kept on a secure, password
protected computer behind a firewall. The PI has the code key. The
Data Manager is responsible for de-identification.
e)
Indicate who will have access to the data or specimens (e.g., research team, sponsors, consultants) and
describe levels of access control (e.g., restricted access for certain persons or groups, access to linked
data or specimens).
Members of the research team will have access to all data. The data
manager has no access to any subject names or contact information.
Off-site collaborators will not have access to PHI or sensitive data.
If the subject requests it explicitly (in writing), we will send
information about certain test results to his/her personal physician.
De-identified data will be shared with collaborating researchers at
Stanford University and at other institutions. De-identified data may
also be shared with collaborating researchers at other institutions
in the future. No names, social security numbers, or other
identifying data will be shared with anyone outside of the research
team at VA.
Blood samples are collected and analyzed at various timepoints during
in-person appointments by the VA Phlebotomy lab, and results are
accessible through the VA's secure medical records system, CPRS.
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 26 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

Blood samples for future use are labeled with the appropriate sample
ID. Samples are pipetted and stored in a locked, secure freezer, and
the sample ID and location is logged in the sample logbook.
Urine samples are collected at the VA and analyzed by the VA specimen
collection laboratory. Urine results are accessible through the VA's
secure medical records system.
f)
If data or specimens will be coded, describe the method in which they will be coded so that study
participants' identities cannot be readily ascertained from the code.
A study code is assigned to a subject after they sign a consent form.
This code is independent of any identifying information. A separate
code is assigned to each blood sample. The participants ID and the
sample ID are linked only through a password protected document on a
secure, password protected computer at the VA Palo Alto.
g)
If data or specimens will be coded, indicate who will maintain the key to the code and describe how it
will be protected against unauthorized access.
The code will be maintained by the PI, and will be available to
appropriate members of the research team but kept in a locked file
cabinet or on a physically secure, password protected computer at VA
Palo Alto.
h)
If sharing data with others, describe how data will be transferred or transmitted (e.g., file transfer
software, file sharing, email). If transmitted via electronic networks, confirm a Stanford University IT
approved platform will be used (see https://uit.stanford.edu/guide/riskclassifications
https://uit.stanford.edu/guide/riskclassifications) or that data will be encrypted while in transit.
Additionally, confirm appropriate agreements are in place to allow for the sharing (see
https://ico.stanford.edu/stanford-researchers/who-will-handle-my-agreement
https://ico.stanford.edu/stanford-researchers/who-will-handle-my-agreement). If using or sharing PHI,
refer to the following policies: https://uit.stanford.edu/security/hipaa
https://uit.stanford.edu/security/hipaa.
No PHI will be transferred to anyone outside the VA/Stanford Redcap. Any electronic transfer of
study information will be done using approved VA methods.
i)
How will you educate research staff to ensure they take appropriate measures to protect the privacy of
participants and the confidentiality of data or specimens collected (e.g. conscious of oral and written
communications, conducting insurance billing, and maintaining paper and electronic data)?
All research staff will complete and remain current with all required
VA and Stanford training prior to working with human subjects. The
Protocol Director will also reinforce the importance of maintaining
confidentiality.
12. Potential Conflict of Interest
Investigators are required to disclose any outside interests that reasonably appear to be related/li to this protocol.
Outside Interest Tasks
Investigators
Role
Potential
Date
Date OPACS
COI Review
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 27 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

COI?
Outside
Interest
Answered
Disclosure
Submitted
Determination
Ansgar Furst
PD
N
06/28/2024
N/A
Jamie Marc
Zeitzer
OP
N
06/14/2024
N/A
Odette Althea
Harris
OP
N
06/25/2024
N/A
Rachel Manber OP
N
06/28/2024
N/A
Jerome A
Yesavage
OP
N
06/04/2024
N/A
13. Consent Background
13. 1
Waiver of Documentation
Phone screen - Telehealth 021323
Check if VA related
Y
a)
Describe the informed consent process. Include the following.
i) Who is obtaining consent? (The person obtaining consent must be knowledgeable about the study.)
ii) When and where will consent be obtained?
iii) How much time will be devoted to consent discussion?
iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to
participate and sign the written consent?
v) What steps are you taking to minimize the possibility of coercion and undue influence?
vi) If consent relates to children and if you have a reason for only one parent signing, provide that
rationale for IRB consideration.
Study personnel listed in the personnel section of this protocol will be the persons who obtain consent.
Consent form will be presented in a private interview room. The potential participant will be given as much
time as they would like to review the material prior to signature. They will be advised that they may take the
form to discuss with a trusted family member, health care provider or other trusted person prior to signature.
These steps along with moderate payment for participation are intended to minimize any undue influence to
participate. No minors are participating.
b)
What is the Procedure to assess understanding of the information contained in the consent? How will
the information be provided to participants if they do not understand English or if they have a hearing
impairment? See HRPP Chapter12.2 for guidance.
All participants must speak and read English to participate. Please see exclusion criteria for more detail.
c)
What steps are you taking to determine that potential participants have the capacity to participate in
the decision-making process? If your study may enroll adults who are unable to consent, describe (i)
how you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains
the capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what
provisions will be made for the assent of the participant.
All participants will be able minded adults. Basic psychological screening will take place and if there are
doubts as to ability to consent then another study member will be called for consult and if doubt remains we
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 28 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

will forgo participation until such time as the potential participant is deemed capable of consent. Only direct
consent will be obtained, no LRA consent will be obtained.
Additional VA questions:
i)
List the people to whom you have formally delegated responsibility to obtain informed consent, and
state whether they have the appropriate training to perform this activity.
Study personnel listed in that section of this protocol will be authorized to obtain consent. Every person has
completed human subjects training and will be further trained on the specific consent for this study.
ii)
Will legally effective informed consent be obtained from the participant or the participant's legally
authorized representative (LAR) or both? If LAR, is it clear who can serve as LAR?
Direct consent only. No LRA.
iii)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence
and provide the prospective participant or their representative sufficient opportunity to consider
whether to participate?
We have limited payment to help prevent undue influence or coercion. Also, participants will be encouraged
to take any time they need and review the consent with their own doctor or other trusted health care
provider, friend or family member before deciding to participate.
iv)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence?
Yes. See above.
v)
Will the information being communicated to the participant or the representative during the consent
process exclude any exculpatory language through which the participant or the representative is made
to waive or appear to waive the participant's legal rights, or release or appear to release the
investigator, the sponsor, the institution, or its agent from liability for negligence (e.g. I give up any
property rights I may have in bodily fluids or tissue samples obtained in the course of the research)?
Yes.
vi)
Please confirm the following:
a. A witness to the participant's signature or the participant's legally authorized representative's
signature will sign and date the consent document.
b. If the sponsor or the IRB requires a witness to the consenting process in addition to the witness to
the participant's signature and if the same person is needed to serve both capacities, a note to that
effect is placed under the witness's signature line.
c. A copy of the signed and dated consent document will be given to the person signing the consent
document.
d. The consent form is on the VA Form 10-1086.
Select ALL applicable regulatory criteria for a Waiver of Documentation and provide a protocol-specific
justification:
1)
45 CFR 46.117(c)(1)(i)., that the only record linking the participants and the research would be
the consent document, and the principal risk would be potential harm resulting from a breach
of confidentiality; each participant (or legally authorized representative) will be asked whether
he/she wants documentation linking the participant with the research, and the participant's
wishes govern.
2)
Y
45 CFR 46.117(c)(1)(ii)., that the research presents no more than minimal risk of harm to
participants and involves no procedures for which written consent is normally required outside
of the research context.
3)
45 CFR 46.117(c)(1)(iii)., if participants or legally authorized representatives (LAR) are
members of a distinct cultural group in which signing forms is not the norm, the research
presents no more than minimal risk and there is an appropriate alternative mechanism for
documenting that informed consent was obtained.
4)
21 CFR 56.109(c)(1)., presents no more than minimal risk of harm to participants and involves
no procedures for which written consent is normally required outside of the research context.
Rationale for above selection:
The phone screen to determine eligibility is no more than minimal risk.
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 29 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

13. 2
Waiver of Documentation
Consent Form 032823
Check if VA related
Y
a)
Describe the informed consent process. Include the following.
i) Who is obtaining consent? (The person obtaining consent must be knowledgeable about the study.)
ii) When and where will consent be obtained?
iii) How much time will be devoted to consent discussion?
iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to
participate and sign the written consent?
v) What steps are you taking to minimize the possibility of coercion and undue influence?
vi) If consent relates to children and if you have a reason for only one parent signing, provide that
rationale for IRB consideration.
i. Trained study personnel will be obtaining consent. All will be trained and knowledgeable about the study.
ii. Consent will be obtained in a private room at the study center or orally during a Telehealth appointment
prior to Screening procedures. Consent will be the first component of participation in this study. iii. 30
minutes is allotted to consent discussion, but it is possible that consent could take up to 60 minutes if
needed. iv & v. First, the information contained in the written informed consent document is explained
verbally to prospective participant in a language they can understand. Repetition is required during any
learning process and is incorporated into the informed consent procedures. Special care is taken to
repeatedly inform prospective participants that their participation is entirely voluntary and that they may
withdraw at any time and for any reason without penalty or loss of currently existing benefits. Prospective
participants are then asked to carefully read the written informed consent form, and any questions are
answered. Next, the prospective participant is asked to summarize the consent form with special focus on
the discomforts, risks, and confidentiality sections. When prospective participants have demonstrated (by
stating in their own words) that they understand the purposes, risks, and benefits of the study, they are asked
to sign and date the last page, or verbally consent (if via Telehealth). The Study Staff and a witness also sign
and date informed consent document, and the participant is given a copy for their records. The emphasis on
the voluntary nature of participation is designed to minimize the possibility of coercion or undue influence
on participation. vi. n/a
b)
What is the Procedure to assess understanding of the information contained in the consent? How will
the information be provided to participants if they do not understand English or if they have a hearing
impairment? See HRPP Chapter12.2 for guidance.
Prospective participants are then asked to carefully read the written informed consent form, and any
questions are answered. Next, the prospective participant is asked to summarize the consent form with
special focus on the discomforts, risks, and confidentiality sections. When prospective participants have
demonstrated (by stating in their own words) that they understand the purposes, risks, and benefits of the
study, they are asked to sign and date the last page, or give verbal consent. Understanding English is a
requirement for this study.
c)
What steps are you taking to determine that potential participants have the capacity to participate in
the decision-making process? If your study may enroll adults who are unable to consent, describe (i)
how you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains
the capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what
provisions will be made for the assent of the participant.
All participants in this study must be able to independently consent to participate.
Additional VA questions:
i)
List the people to whom you have formally delegated responsibility to obtain informed consent, and
state whether they have the appropriate training to perform this activity.
N/A - PI only at this time. Once study personnel is hired and trained: The persons obtaining consent will be
one of the investigators, the study coordinator, or a research assistant, all of whom have been trained to give
informed consents. All staff will have completed the required training in Human Subjects, Good Clinical
Practice, and HIPAA.
ii)
Will legally effective informed consent be obtained from the participant or the participant's legally
authorized representative (LAR) or both? If LAR, is it clear who can serve as LAR?
All participants in this study must be able to independently consent to participate. LAR is not applicable.
iii)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence
and provide the prospective participant or their representative sufficient opportunity to consider
whether to participate?
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 30 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

Potential participants will be encouraged to take as much time as they feel they need to make a decision
about participation and to review the document with anyone whose advice they would like with regards to
participation. Potential participants will be informed that choosing not to participate will in no way effect
their clinical care at the VA and that participation is absolutely voluntary.
iv)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence?
Potential participants will be encouraged to take as much time as they feel they need to make a decision
about participation and to review the document with anyone whose advice they would like with regards to
participation. Potential participants will be informed that choosing not to participate will in no way effect
their clinical care at the VA and that participation is absolutely voluntary.
v)
Will the information being communicated to the participant or the representative during the consent
process exclude any exculpatory language through which the participant or the representative is made
to waive or appear to waive the participant's legal rights, or release or appear to release the
investigator, the sponsor, the institution, or its agent from liability for negligence (e.g. I give up any
property rights I may have in bodily fluids or tissue samples obtained in the course of the research)?
Yes. No exculpatory language will be used.
vi)
Please confirm the following:
a. A witness to the participant's signature or the participant's legally authorized representative's
signature will sign and date the consent document.
b. If the sponsor or the IRB requires a witness to the consenting process in addition to the witness to
the participant's signature and if the same person is needed to serve both capacities, a note to that
effect is placed under the witness's signature line.
c. A copy of the signed and dated consent document will be given to the person signing the consent
document.
d. The consent form is on the VA Form 10-1086.
Select ALL applicable regulatory criteria for a Waiver of Documentation and provide a protocol-specific
justification:
1)
45 CFR 46.117(c)(1)(i)., that the only record linking the participants and the research would be
the consent document, and the principal risk would be potential harm resulting from a breach
of confidentiality; each participant (or legally authorized representative) will be asked whether
he/she wants documentation linking the participant with the research, and the participant's
wishes govern.
2)
45 CFR 46.117(c)(1)(ii)., that the research presents no more than minimal risk of harm to
participants and involves no procedures for which written consent is normally required outside
of the research context.
3)
45 CFR 46.117(c)(1)(iii)., if participants or legally authorized representatives (LAR) are
members of a distinct cultural group in which signing forms is not the norm, the research
presents no more than minimal risk and there is an appropriate alternative mechanism for
documenting that informed consent was obtained.
4)
Y
21 CFR 56.109(c)(1)., presents no more than minimal risk of harm to participants and involves
no procedures for which written consent is normally required outside of the research context.
Rationale for above selection:
This study's procedures present minimal risk of harm to participants. This research is not FDA
regulated, involves no investigational devices or drugs, collects low risk data and provides a short,
low risk cognitive/behavioral intervention.
14. Assent Background (less than 18 years of age)
15. HIPAA Background
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 31 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

15. 1
Waiver of Authorization for
Recruitment
phone screen hipaa
a)
Describe the protected health information (PHI) needed to conduct screening or recruitment. PHI is
health information linked to HIPAA identifiers. List BOTH health information AND HIPAA
identifiers. If you are using STARR, use the Data Privacy Attestation to ensure that your request will
match your IRB-approved protocol.
We are collecting the following identifiable information or PHI: * full name, * social security number (for
VA hospital registration and payment), * telephone number (for communication), * mailing address (for
appointment notices and to mail payment), * date of birth (study metric), * date of visit, * VA CPRS
medical record * Medical history and physical examination information, * Demographic information
(gender, ethnicity, education, occupation) * Progress notes, * Biological specimens (e.g. blood, urine, spinal
fluid), * Diagnostic/Laboratory test results, * Discharge summary, * Survey/Questionnaire responses, *
Cognitive and Psychological test results.
b)
Please Answer:
Y
Do you certify that the use or disclosure of protected health information involves no more than a
minimal risk to the privacy of individuals?
Y
Do you certify that the research could not practically be conducted with out the waiver?
Y
Do you certify that you have adequate written assurances that the protected health information will
not be reused or disclosed to any other person or entity, except as required by law, for authorized
oversight of the research project, or for other research for which the use or disclosure of protected
health information would be permitted?
Y
Do you certify that the research could not practically be conducted with out access to and use of the
protected health information?
c)
Please describe an adequate plan to protect any identifiers from improper use and disclosure.
Information from the telephone screening will be protected from breach of confidentiality through several
safeguards including password protected computers, locked offices, doors, and file cabinets, and secure
computer networks as described previously in the IRB application.
d)
Please describe an adequate plan to destroy the identifiers at the earliest opportunity consistent with
conduct of the research, unless there is a health or research justification for retaining the identifiers
or such retention is otherwise required by law.
If potential participants are found to be ineligible for or uninterested in participation in the study, records
will be securely maintained until such time as their destruction is allowed by an approved and published VA
schedule of record retention.
15. 2
Waiver of Authorization
waiver of authorization
a)
Describe the Protected Health Information (PHI) needed to conduct the research. PHI is health
information linked to HIPAA identifiers. List BOTH health information AND HIPAA identifiers. If
you are using STRIDE, use the Data Privacy Attestation to ensure that your request will match your
IRB-approved protocol.
We are collecting the following identifiable information or PHI: * full name, * social security number (for
VA hospital registration and payment), * telephone number (for communication), * mailing address (for
appointment notices and to mail payment), * date of birth (study metric), * date of visit, * VA CPRS
medical record * Medical history and physical examination information, * Demographic information
(gender, ethnicity, education, occupation) * Progress notes, * Biological specimens (e.g. blood, urine, spinal
fluid), * Diagnostic/Laboratory test results, * Discharge summary, * Survey/Questionnaire responses, *
Cognitive and Psychological test results.
b)
Please Answer:
Y
Do you certify that the use or disclosure of protected health information involves no more than a
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 32 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

minimal risk to the privacy of individuals?
Y
Do you certify that the research could not practically be conducted with out the waiver?
Y
Do you certify that you have adequate written assurances that the protected health information will
not be reused or disclosed to any other person or entity, except as required by law, for authorized
oversight of the research project, or for other research for which the use or disclosure of protected
health information would be permitted?
Y
Do you certify that the research could not practically be conducted with out access to and use of the
protected health information?
c)
Please describe an adequate plan to protect any identifiers from improper use and disclosure.
Identifiers will be protected as described in section 11 of the protocol application
d)
Please describe an adequate plan to destroy the identifiers at the earliest opportunity consistent with
conduct of the research, unless there is a health or research justification for retaining the identifiers
or such retention is otherwise required by law.
Identifiers will be maintained until December 31, 2075 or when the research project is complete, whichever
is sooner.
16. Attachments
Attachment Name
Attached Date
Attached By
Submitted Date
TBI-CBTi final submission
07/28/2017
ajfurst
VARQs Furst 41040
07/28/2017
ajfurst
VA Business Card
10/15/2018
lienlwu
Directions & Contact
10/15/2018
lienlwu
Q&A
10/15/2018
lienlwu
Acute_Unstable_Chronic_Illn
ess_Checklist
10/25/2018
rayma
BerlinSleepApnea
10/25/2018
rayma
Boston_Lifeteime_Assessmen
t_TBI_Questionnaire
10/25/2018
rayma
Boston_Lifetime_Assessment
_TBI
10/25/2018
rayma
Brief_Pain_Inventory
10/25/2018
rayma
Credibility_Expectancy_Ques
tionnaire
10/25/2018
rayma
Epworth_Sleepiness_Scale
10/25/2018
rayma
Functional Outcomes of Sleep
Questionnaire
10/25/2018
rayma
Insomnia_Severity_Index
10/25/2018
rayma
MedicationList
10/25/2018
rayma
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 33 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

MINI 7.0.2 Standard
10/25/2018
rayma
Penn_State_Worry_Questionn
aire
10/25/2018
rayma
PTSD_Checklist_DSM5
10/25/2018
rayma
Sleep Diary - Consensus E
10/25/2018
rayma
Treatment_Satisfaction
10/25/2018
rayma
Veteran's Rand 36 Item
Health Survey
10/25/2018
rayma
Working_Alliance_Inventory
for Participant
10/25/2018
rayma
Working_Alliance_Inventory
for Therapist
10/25/2018
rayma
DUKE
10/25/2018
rayma
CANTAB Cognitive Test
Security Info
10/25/2018
rayma
PSG - Compumedics Siesta
Brochure
10/25/2018
rayma
PSG - Compumedics
Quik-Cap Brochure
10/25/2018
rayma
Morningness Eveningness
Questionnaire
10/25/2018
rayma
CANTAB Cognitive Test
Overview
10/25/2018
rayma
CBTI - A Guide to
Overcoming Insomnia
10/25/2018
rayma
CBTI - Behavioral
Experiments record sheet
10/25/2018
rayma
CBTI - Brief Positive and
negative beliefs about
sleep-related worry quaire
10/25/2018
rayma
CBTI - Case
Conceptualization Form
10/25/2018
rayma
CBTI - Cognitive
restructuring questions
10/25/2018
rayma
CBTI - Definition of
automatic thoughts
10/25/2018
rayma
CBTI - Management of
unwanted thought
handout_vic
10/25/2018
rayma
CBTI - monitoring examples
10/25/2018
rayma
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 34 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

handout
CBTI - Monitoring for
information about sleep
10/25/2018
rayma
CBTI - Monitoring for
monitoring form
10/25/2018
rayma
CBTI - Personalized case
conceptualization
10/25/2018
rayma
CBTI - Questions and
Answers about Guidelines
10/25/2018
rayma
CBTI - Reasons for Feeling
Tired
10/25/2018
rayma
CBTI - Safety behaviors
examples handout
10/25/2018
rayma
CBTI - safety behaviors
correction form
10/25/2018
rayma
CBTI - safety behaviors
questionnaire_32 items
10/25/2018
rayma
CBTI - SAMI_quaire for
monitoring attentional bias
10/25/2018
rayma
CBTI - Sleep Alteration
Instructions
10/25/2018
rayma
CBTI - Sleep and Wake and
the Daily Temperature Pattern
10/25/2018
rayma
CBTI - Sleep Hygiene
10/25/2018
rayma
CBTI - Sleep regulation slide
10/25/2018
rayma
CBTI - Sleep Restriction
figure
10/25/2018
rayma
CBTI - Spielman_Three P
Model
10/25/2018
rayma
CBTI - Staying Awake Until
Your Scheduled Bedtime
10/25/2018
rayma
CBTI - Things to do if you are
awake_update
10/25/2018
rayma
CBTI - Thinking traps
handout
10/25/2018
rayma
CBTI - Thought Control
Questionnaire Insomnia
10/25/2018
rayma
CBTI - Treatment Goals Form 10/25/2018
rayma
CBTI - Trouble with
estimating sleep handout
10/25/2018
rayma
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 35 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

CBTI - Why questions
handout
10/25/2018
rayma
Study Visual Diagram - For
Participants
10/25/2018
rayma
Participant Contact -
Appointment letters
10/25/2018
rayma
Participant Contact -
Appointment schedules
10/25/2018
rayma
Treatment_Adherence_Questi
onnaire_ABTI
10/29/2018
rayma
Treatment_Adherence_Questi
onnaireCBT
10/29/2018
rayma
CBTI - Sleep Need
Questinnaire
10/29/2018
rayma
CBTI - Action plan for
addressing future insomnia
10/29/2018
rayma
ABTI - 8_Item_Hierarchy
10/29/2018
rayma
ABTI -
Brief_Assessment_form
10/29/2018
rayma
ABTI -
Brief_Initial_Assessment_Scr
ipt
10/29/2018
rayma
ABTI - Healthy_Sleep_Habits 10/29/2018
rayma
ABTI -
Instructions_For_Practicing_
Desensitization
10/29/2018
rayma
ABTI -
Rationale_for_Treatment
10/29/2018
rayma
ABTI - Sleep_Education
10/29/2018
rayma
Marijuana_Use_Discussion_T
ool
10/29/2018
rayma
Understanding alcohol effects
on the body
10/29/2018
rayma
Debriefing Script 10/30
10/30/2018
rayma
Duke - annotated
11/02/2018
rayma
Trail_Making Instructions
11/02/2018
rayma
Trail_Making_AB_scoring_a
nd_sheets
11/02/2018
rayma
Columbia_Suicide_Severity
Rating Scale
11/02/2018
rayma
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 36 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

Recruitment Form with
Consent for Chart Review
12/11/2018
rayma
Introductory Letter
02/04/2019
rayma
NewspaperAd
02/04/2019
rayma
Recruitment Letter Cosigned
by Provider
02/04/2019
rayma
Recruitment letter from Dr
Bayley
04/01/2019
rayma
Duke screening form
04/01/2019
rayma
Caffeine chart
04/01/2019
rayma
VA Flyer v2
05/07/2019
rayma
VA postcard
05/07/2019
rayma
Waiver of HIPAA
Authorization for Research
05/07/2019
rayma
Study Business card - 053119
06/03/2019
rayma
Sleep Diary - One night PSG
06/03/2019
rayma
PSG participant info sheet
06/03/2019
rayma
Study postcard 060619
06/06/2019
rayma
PSG Disconnect Form
06/10/2019
rayma
Participant Eligibility Form
06/11/2019
rayma
CBTI - Things to do if you are
awake
07/31/2019
rayma
CBTI - Changing your
thoughts about sleep
07/31/2019
rayma
Brochure_v2
01/07/2020
rayma
Information_Card_Participant
s
01/07/2020
rayma
Alternative_Treatments_Lette
r
01/07/2020
rayma
Introductory
Letter_Concussion_v2
01/17/2020
rayma
PHQ9_noScore
01/17/2020
rayma
Headache_Impact_Test_noSc
ore
01/17/2020
rayma
DBAS
01/17/2020
rayma
Duke Checklists
02/11/2020
rayma
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 37 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

ImportantInfo_forParticipants 03/16/2020
rayma
VA Telehealth Memo -
COVID19
03/25/2020
rayma
FinalContactLetter
06/25/2020
rayma
Suicidality Protocol -
Telehealth
06/25/2020
rayma
Suicidality Protocol - Phone
calls
06/25/2020
rayma
AdverseEvents - 062520
06/25/2020
rayma
WebAdvertisingMockups
06/25/2020
rayma
Web_PreScreen
07/06/2020
rayma
ImportantInfo_ForTelehealth
07/06/2020
rayma
VAVideoConnectHandout
07/06/2020
rayma
HIPAA Waiver of Consent
07/24/2020
rayma
Participant_Telehealth_Instru
ctions
09/11/2020
rayma
Telehealth Recruitment Letter
from Wes
09/11/2020
rayma
Telehealth_Introductory_lette
r
09/11/2020
rayma
Text Email Secure Message
templates
11/09/2020
rayma
01042021SleeplessWarriorsSt
udyCampaignCreative
01/06/2021
rayma
Text Email Secure Message
templates 010621
01/06/2021
rayma
Telehealth flyer 010621
01/06/2021
rayma
Alternative Treatment
Resources - National
08/10/2022
rayma
Sleep Diary - updated
02/09/2023
rayma
Demographics 2023
02/13/2023
rayma
Obligations
The Protocol Director agrees to:
•
Adhere to principles of sound scientific research designed to yield valid results
•
Conduct the study according to the protocol approved by the IRB
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 38 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

•
Be appropriately qualified to conduct the research and be trained in Human Research protection, ethical
principles, regulations, policies and procedures
•
Ensure all Stanford research personnel are adequately trained and supervised
•
Ensure that the rights and welfare of participants are protected including privacy and confidentiality of data
•
Ensure that, when de-identified materials are obtained for research purposes, no attempt will be made to
re-identify them.
•
Disclose to the appropriate entities any potential conflict of interest
•
Report promptly any new information, modification, or unanticipated problems that raise risks to
participants or others
•
Apply relevant professional standards.
Any change in the research protocol must be submitted to the IRB for review prior to the implementation of
such change. Any complications in participants or evidence of increase in the original estimate of risk should
be reported at once to the IRB before continuing with the project. Inasmuch as the Institutional Review
Board (IRB) includes faculty, staff, legal counsel, public members, and students, protocols should be written
in language that can be understood by all Panel members. The investigators must inform the participants of
any significant new knowledge obtained during the course of the research.
IRB approval of any project is for a maximum period of one year. For continuing projects and activities, it is
the responsibility of the investigator(s) to resubmit the project to the IRB for review and re-approval prior to
the end of the approval period. A Notice to Renew Protocol is sent to the Protocol Director 7 weeks prior to
the expiration date of the protocol.
https://stanfordmedicine.box.com/shared/static/qbsi8u8h47qsotxhdpuzz50xlrqa0sgo.pdf Report promptly any
new information, complaints, possibly serious and/or continuing noncompliance, or unanticipated problems
involving risks to participants or others.
All data including signed consent form documents must be retained for a minimum of three years past the
completion of the research. Additional requirements may be imposed by your funding agency, your
department, or other entities. (Policy on Retention of and Access to Research Data, Research Policy
Handbook,
http://doresearch.stanford.edu/policies/research-policy-handbook/conduct-research/retention-and-access-research-data)
APPROVAL LETTER/NOTICE NOTE: List all items (verbatim) that you want to be included in your
approval letter (e.g., Amendment date, Investigator's Brochure version, consent form(s) version(s),
advertisement name, etc.) in the box below.
Y
By checking this box, I verify that I, as the Protocol Director (PD) responsible for this research protocol,
have read and agree to abide by the above obligations, or that I have been delegated authority by the PD to
certify that the PD has read and agrees to abide by the above obligations.
Protocol # 41040 ( Continuing Review )
PROTOCOL
PD: Ansgar Furst
APPLICATION FORM
Page 39 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Approval Period:
07/31/2024 - 07/31/2025

Statistical Analysis Plan 
In testing Hypotheses 1 and 2, treatment response will be evaluated in terms of improvement in 
the Insomnia Severity Index (ISI) from baseline to end of the 6-week treatment.  
 
Primary Hypothesis 1: Efficacy of CBT-I compared to a manualized active control condition, 
Arousal Based Therapy for Insomnia (ABT-I). To test the hypothesis that CBT-I will show 
efficacy for insomnia in TBI patients at the end of the 6-week treatment period, compared to the 
control condition (ABT-I) we will regress change in ISI on treatment (CBT-I versus ABT-I; 6 
weeks vs. baseline). We will run analogous models to test for persistent treatment effects at the 
16 and 24-week follow-up points. In each set of models the dependent variable will first be the 
change relative to baseline in our primary outcome measure of insomnia change defined by the 
ISI scores. We will covary for comorbid PTSD severity and amount of medication use (SSRIs) 
as required, if the frequency of such differs by treatment group. 
 
Secondary Hypothesis 2: Moderators and Mediators of response. Our previous design 
separated Sleep Restriction (SR) and Cognitive Therapy (CT) components of CBT-I, however, 
we feel that although the design of the study has been changed, we can still gather some 
preliminary data on likely moderators and mediators of CBT-I, SR and CT while conducting the 
clinical trial and testing our Primary Hypothesis. Thus, we can still determine whether changes 
in potential moderators and mediators of SR and CT might also moderate or mediate the effects 
of the entire CBT-I package. 
 
Exploratory analyses will compare the predictive usefulness of all measures listed in Table 5. In 
more detail, we will fit regression models for change in ISI on treatment, the continuous 
moderator and the treatment by moderator interaction. Baseline Medication use and PTSD 
should be similar across groups due to randomization and use of the blocking procedures 
(Section 2.a.3.b.5). The analysis may be adjusted for other covariates (age and alcohol use) if 
they are significantly different between groups at baseline despite randomization. We will use 
percentile, bootstrap confidence intervals to determine the moderator value, if any, at which 
there is a change in the optimal choice of treatment (i.e. the point of intersection at which one 
treatment first surpasses another). Our results will allow us to choose the optimal treatment 
based on individual moderator values and estimate the comparative advantage of one treatment 
over another given a specific moderator value. The confidence intervals will also show the 
moderator values, if any, for which the difference between treatments is statistically or clinically 
insignificant. 
Secondary Hypothesis 2: Mechanisms of Action (Mediators). As in the case of moderators of 
treatment response, since our design has changed mediators of treatment response are 
reduced in prominence in this proposal. Nonetheless, we feel some exploratory analyses may 
be carried out. For example, we hypothesize that changes in TIB with its associated increase in 
homeostatic pressure for sleep may account for some of the effects of SR and that changes in 
measures of worry and pain may explain some of the effects of CT. In the package of combined 
SR plus CT (CBT-I) this may still be the case for the group as a whole. Therefore, we will 
conduct secondary analyses using the bootstrap strategy for mediator analysis formulated by 
Preacher and Hayes [98] to address this possibility. Specifically, we will fit three separate 
regression models to estimate the indirect effect of treatment through the mediator: 1) Change 
in ISI on treatment; 2) Change in mediator on treatment; and 3) Change in ISI on treatment plus 
change in mediator. Each model will be adjusted for the same covariates described above. We 
will estimate the indirect effect as the product of the treatment effect in (2) and the mediator  

effect in (3). We will compare the indirect effect to the total effect of treatment, estimated in (1), 
to determine how much of the total effect of treatment is accounted for by the mediator. Due to 
the non-normality of the estimates, percentile bootstrap confidence intervals for the mediator 
effects will be computed and their statistical significance assessed. We propose to use multiple 
imputation [99, 100] and an analyses based on total ISI change over the course of the study. 
Additional mediator analyses will be performed for relevant measures listed in Table 5. 
Likelihood of Obtaining Useful Results. For our primary hypothesis we considered a target 
power of 80% with a two-tailed test at 5% significance in an Intention-to-Treat (ITT) analysis. 
We will require 60 subjects per group (for a total of 120 in the two groups) to detect a main 
effect of treatment group with an effect size that increases R-squared by 6% or more, with 
respect to the continuous outcome variable (ISI improvement). Thus we feel that the sample of 
60 per group is adequate. Power analyses were computed using G*Power Version 3.1.9.2 
[101]. 
Considerations Regarding Sleep Medication Changes During the Study. Tentatively, we would 
consider patients who required a sleep medication increase a treatment failure and they would 
be scored accordingly. We would interpret a decrease in medications a sign that therapy was 
working and assume that the ISI ratings would reflect a treatment success. We plan to monitor 
these assumptions with our statistical team and adjust our analyses appropriately. 
Other analyses. The above is meant to be a brief outline of our analytic approach. Other 
analyses will be conducted including examination of secondary outcomes such as Quality of Life 
measures. 

 
RESEARCH CONSENT FORM 
 Title of Study:  Non-pharmacological treatments for insomnia in chronic traumatic brain injury     eProtocol #41040 
Principal Investigator:  Ansgar J. Furst, PhD 
VAMC: 
VA Palo Alto HCS 
 
VA Form 10-1086 
 
Page 1 of 13 
 
IRB Use Only 
Approval Date: July 31, 2023 
Expiration Date:  July 31, 2024 
Non-pharmacological treatments for insomnia inchronic 
traumatic brain injury 
PURPOSE OF RESEARCH  
You are invited to participate in a research study of non-drug treatments for insomnia in Veterans with 
chronic traumatic brain injury.  We hope to learn which of two treatments works best for adults with 
specific sleep problems.  Specifically, we will compare and contrast Cognitive Behavioral Therapy with 
Arousal-Based Therapy for Insomnia.  You were selected as a possible participant in this study because 
you may have insomnia. 
This project plans to enroll about 120 research study participants with insomnia to participate in this 
study. The study will be conducted at VA Palo Alto Health Care System by the Principal Investigator, 
Dr. Ansgar Furst. 
VOLUNTARY PARTICIPATION  
Your participation in this study is entirely voluntary.  Your decision not to participate will not have any 
negative effect on you or your medical care.  You can decide to participate now, but withdraw your 
consent later and stop being in the study without any loss of benefits or medical care you are entitled to. 
You have the right to refuse to answer particular questions.    
DURATION OF STUDY INVOLVEMENT  
Participation in this study will require two sessions for initial evaluation, six sessions for treatment - 
once per week for six consecutive weeks - one session at end of treatment and one session 
approximately six months after completion of the treatment for follow-up. Study participation will take 
place across a total of approximately eight months.   
PROCEDURES 
If you decide to participate in the study, you will go through a series of screening steps to determine the 
nature of your sleep problem.  The order of these steps may vary.  If at any point during the screening 
portion of this study, we determine that our treatments are not appropriate for your sleep problem, we 
will end your participation in this study and suggest possible referral resources.  
Screening Session 
The initial evaluation begins with a screening session to determine if you are a good fit for the study.  
During this screening session, we will ask you to complete several interviews and questionnaires to 
gather information about your sleep and general health You will also have a chance to bring up issues 
you believe are relevant to your sleep problem.   

 
RESEARCH CONSENT FORM 
 Title of Study:  Non-pharmacological treatments for insomnia in chronic traumatic brain injury     eProtocol #41040 
Principal Investigator:  Ansgar J. Furst, PhD 
VAMC: 
VA Palo Alto HCS 
 
VA Form 10-1086 
 
Page 2 of 13 
 
IRB Use Only 
Approval Date: July 31, 2023 
Expiration Date:  July 31, 2024 
Medications 
Participants may take medications, drugs, herbal remedies, or hormones specifically prescribed for treating 
sleep disturbances while participating in the study. Sleep medications are acceptable if stable (at least 3 
weeks of same dose/timing/formulation) at the time of recruitment. Other medications, including those 
with sleep side-effects, are acceptable if stable (at least 3 weeks of same dose/timing/formulation) at the 
time of recruitment.  
Once enrolled in the study, changes to these medication (starting, stopping or changing the dose) may 
result in delays in treatment or your withdrawal from this study. Please inform us immediately of any 
recent or expected changes to your medications. 
Your responses to questions concerning illegal drug use will be kept confidential by us, but could be self-
incriminating and harmful to you if they became known outside the study. As explained in the 
confidentiality statement of the consent, we do not intend to disclose this information. 
Other Psychological Therapies and Interventions 
Concurrent psychotherapy is allowed in most cases. If you decide to start another new therapy or research 
study at the time of your enrollment in this study, your participation may be delayed or you may be 
withdrawn from this study. Please inform us of any recent or expected changes to other therapies. 
Sleep Logs.  
During the first session, we will show you how to complete daily sleep reports.  A sleep report is designed 
to gather information about your daily sleep pattern. You will be asked to keep a daily sleep report for the 
two weeks of initial evaluation, the entire six-week treatment period and for one week at the six-month 
follow-up. 
When you have completed the screening session described above, we will determine if our study is 
appropriate for you. If so, you will have a fifty percent chance to be assigned to one of two treatments: 
Cognitive Behavioral Therapy or Arousal-Based Therapy for Insomnia. 
 Baseline Session 
Before treatment begins, you will meet with study staff to complete some additional interviews and 
questionnaires about the nature of your sleep problem and general health. We will also ask you to 
complete some tasks to test your memory and attention. Prior to this appointment, we will ship you an 
iPad for you to borrow which you will use to complete these memory and attention tasks. You can also 
use this iPad to fill out surveys and meet with study staff on video calls. The iPad will need to be 
returned at the end of treatment. 

 
RESEARCH CONSENT FORM 
 Title of Study:  Non-pharmacological treatments for insomnia in chronic traumatic brain injury     eProtocol #41040 
Principal Investigator:  Ansgar J. Furst, PhD 
VAMC: 
VA Palo Alto HCS 
 
VA Form 10-1086 
 
Page 3 of 13 
 
IRB Use Only 
Approval Date: July 31, 2023 
Expiration Date:  July 31, 2024 
Treatment 
You will have a fifty percent chance to be assigned to one of two treatments: Cognitive Behavioral 
Therapy for Insomnia (CBT-I) or Arousal-Based Therapy for Insomnia (ABT-I). The two therapies 
teach you different skills and techniques to help reduce insomnia symptoms.  
The treatment part of the study lasts six weeks and you will complete a sleep report for each day during 
treatment. During the treatment, you will meet with the therapist for a total of six sessions: once per 
week for six consecutive weeks. Each session lasts approximately 60 minutes.   
Cognitive Behavioral Therapy for Insomnia (CBT-I) 
This therapy addresses thoughts and behaviors that can interfere with sleep. Thoughts and behaviors that 
develop in response to insomnia can result in heightened anxiety about sleep and the development of 
coping strategies that can ultimately worsen insomnia. This therapy aims to alter behaviors that 
contribute to sleep problems, and correct the beliefs that drive those behaviors. Therapy will also include 
sleep education. 
Arousal-Based Therapy for Insomnia (ABT-I) 
This therapy addresses the heightened state of alertness or anxiety that can occur when experiencing 
difficulty sleeping. This heightened state of arousal develops over time in response to insomnia, and can 
make falling asleep more difficult. Since this response is learned, it can also be unlearned. This therapy 
teaches skills to reduce the heightened arousal that contributes to insomnia. Therapy will also include 
sleep education. 
Audio Recording. 
We will make an audio recording of each treatment session, which will be evaluated by a research 
psychologist for quality control. All audio recordings will be kept in a locked cabinet for the VA-
required period of 6 years after study closure, then destroyed.  
__________ Yes, I give permission for audio recordings to be made, as set forth above. 
__________ No, I do not give permission for audio recordings to be made. 
End of Treatment Follow-up 
At the end of the 6-week treatment period, you will be asked to complete a 7-day sleep log, and then 
attend another meeting to repeat some of the interviews and questionnaires that you completed at the 
beginning of the study. You will also be asked to complete the same memory and attention tasks at this 
appointment that you completed at the Baseline appointment. The iPad and charger shipped at the 
beginning of the study will need to be returned after you complete the End of Treatment Follow-up. 

 
RESEARCH CONSENT FORM 
 Title of Study:  Non-pharmacological treatments for insomnia in chronic traumatic brain injury     eProtocol #41040 
Principal Investigator:  Ansgar J. Furst, PhD 
VAMC: 
VA Palo Alto HCS 
 
VA Form 10-1086 
 
Page 4 of 13 
 
IRB Use Only 
Approval Date: July 31, 2023 
Expiration Date:  July 31, 2024 
6-Month Follow Up 
We expect the benefits of your treatment to continue and improve with time, thus we encourage you to 
continue practicing the treatment instructions to maintain your progress. Six months after you have 
completed the treatment, we will ask you to complete a 7-day sleep diary and an updated medication 
list. We will ask you to meet us to complete the interviews and questionnaires for a third and final 
time. An iPad will be shipped to you once more to use for the memory and attention tasks completed at 
this visit. The iPad and charger should be shipped back after completing the 6-Month Follow Up visit. 
PARTICIPANT RESPONSIBILITIES 
As a study participant, your responsibilities include:  
• Follow the instructions of the investigators and study staff. 
• Keep your study appointments.  If it is necessary to miss an appointment, please contact the 
investigators or research study staff to reschedule as soon as you know you will miss the 
appointment. 
• Tell the investigators or research study staff about any side effects, doctor visits, or 
hospitalizations that you may have. 
• Keep your sleep diaries as instructed. 
• Complete your questionnaires as instructed. 
• Ask questions as you think of them. 
• Tell the investigators or research staff if you change your mind about staying in the study. 
WITHDRAWAL FROM STUDY 
If you first agree to participate and then you change your mind, you are free to withdraw your consent 
and stop your participation at any time.  If you decide to withdraw from the study, you will not lose any 
benefits to which you would otherwise be entitled and your decision will not affect your ability to 
receive medical care for any condition.  
If you want to stop being in the study you should tell the investigators or study staff.  You can do this by 
phone by calling the research assistants at 650-852-3426 or the Principal Investigator, Dr. Ansgar Furst, 
at 650-493-5000 extension 68652. 
If you withdraw from the study for any reason, you must return any study-related equipment still in your 
possession. 
The investigators may also withdraw you from the study without your consent for one or more of the 
following reasons:   
• Failure to follow the instructions of the investigators and/or study staff. 

 
RESEARCH CONSENT FORM 
 Title of Study:  Non-pharmacological treatments for insomnia in chronic traumatic brain injury     eProtocol #41040 
Principal Investigator:  Ansgar J. Furst, PhD 
VAMC: 
VA Palo Alto HCS 
 
VA Form 10-1086 
 
Page 5 of 13 
 
IRB Use Only 
Approval Date: July 31, 2023 
Expiration Date:  July 31, 2024 
• The investigators decide that continuing your participation could be harmful to you. 
• You need treatment not allowed in the study. 
• The study is cancelled.  
• Other administrative reasons. 
• Unanticipated circumstances. 
 
POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES  
There are risks, discomforts, and inconveniences associated with any research study.  These deserve 
careful thought.  You should talk with the Principal Investigator if you have any questions. This study 
involves the following risks, discomforts, and possible inconveniences:  
Evaluation and testing. There are virtually no risks involved in the cognitive testing and psychological 
measurements other than the anxiety that can be associated with any test. It is possible that you might 
become tired or frustrated by some of our testing. You may find answering the questionnaires annoying, 
boring, or repetitive. If this happens, please tell us and we will take a break or skip a particularly 
difficult test. Evaluations of mood and mental status may be slightly frustrating or produce fatigue and 
boredom. If the research staff has reason to believe you may be having suicidal thoughts, you will be 
asked to speak to a clinician trained in suicidality risk assessment. 
Sleep Log and Questionnaires. There are no harmful effects to filling out the sleep log and 
questionnaires, but you may find answering the questionnaires annoying or boring. All paper data 
collected will be stored in a locked cabinet at the Palo Alto VA accessible only by study staff. De-
identified data from web-based surveys and tests will be stored on server to which only approved study 
staff will have access. 
There is always the possibility that your sleep might get worse during treatment. In general, most 
patients benefit from the proposed treatments, but it is always possible that an individual can experience 
unwanted changes in their sleep pattern.   
Non-pharmacological treatments for insomnia like Cognitive Behavioral Therapy and Arousal-Based 
Therapy may lead you to challenge some of your thoughts and concerns about the way you sleep. The 
treatment may lead you to adopt a more flexible cognitive stance regarding your sleep. Some people 
may find this uncomfortable. In addition, you may feel overly sleepy, cranky, or disoriented during the 
first few days of treatment. It is recommended that you avoid driving, operating machinery, or doing 
activities that require close attention for the first few days of therapy.  Sleep efficiency training has been 
known to trigger seizures in people with seizure disorders and to have possible negative effects on mood 
in people with bipolar disorder. For this reason, people with these disorders are not eligible for this 
study.  

 
RESEARCH CONSENT FORM 
 Title of Study:  Non-pharmacological treatments for insomnia in chronic traumatic brain injury     eProtocol #41040 
Principal Investigator:  Ansgar J. Furst, PhD 
VAMC: 
VA Palo Alto HCS 
 
VA Form 10-1086 
 
Page 6 of 13 
 
IRB Use Only 
Approval Date: July 31, 2023 
Expiration Date:  July 31, 2024 
POTENTIAL BENEFITS 
There may be no direct benefits to you for participation in this study. Your sleep may improve. Your 
participation may help us to learn more about the causes of insomnia.  
WE CANNOT AND DO NOT GUARANTEE OR PROMISE THAT YOU WILL RECEIVE ANY 
DIRECT BENEFITS FROM THIS STUDY.  
ALTERNATIVES 
You do not have to participate in this research study in order to receive treatment for any medical 
condition. There are other behavioral treatments for sleep problems, as well as various drug treatments 
for sleep problems, that are not included in this study. A study clinician can discuss any alternatives with 
you before you agree to participate in this study. 
PARTICIPANT’S RIGHTS 
Your participation is voluntary. You should not feel obligated to agree to participate.  Your questions 
should be answered clearly and to your satisfaction.  
You will be told of any important new information that is learned during the course of this research 
study, which might affect your condition or your willingness to continue participation in this study. 
ClinicalTrials.gov 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law.  This Web site will not include information that can identify you.  At most, the Web site will 
include a summary of the results.  You can search this Web site at any time. 
CONFIDENTIALITY 
We will keep your name and all the information you tell us in this study as confidential as possible.  We 
may publish the results of this study for others to read about, but you will not be identified in any 
articles about the study by name, social security number, address, telephone number, or any other direct 
personal identifier.  Also, other federal agencies as required, such as the VA Office of Research 
Oversight and the VA Office of the Inspector General may have access to your information.  
If you decide to participate in other studies at the VA or Stanford Sleep Center, data about you from this 
study may be combined with data about you collected for other studies.  
It is possible that, based on information gained from this study, the researchers may be required to report 
information (e.g., information relating to suicide, physical or sexual abuse) to the appropriate authorities. 

 
RESEARCH CONSENT FORM 
 Title of Study:  Non-pharmacological treatments for insomnia in chronic traumatic brain injury     eProtocol #41040 
Principal Investigator:  Ansgar J. Furst, PhD 
VAMC: 
VA Palo Alto HCS 
 
VA Form 10-1086 
 
Page 7 of 13 
 
IRB Use Only 
Approval Date: July 31, 2023 
Expiration Date:  July 31, 2024 
FUTURE USE OF PRIVATE INFORMATION 
Research using private information is an important way to try to understand human disease.  You are 
being given this information because the investigators want to save private information for future 
research.   
Identifiers might be removed from identifiable private information and, after such removal, the 
information could be used for future research studies or distributed to another investigator for future 
research studies without additional informed consent from you. 
FINANCIAL CONSIDERATIONS 
Payments. You will receive $25 for the screening session.  If you are determined to be eligible for the 
study, you will receive an additional $50 for completing the baseline session. You will receive stipends 
of $25 for all 6 treatment visits thereafter (6 x $25 = $150) and $50 each for the 2 follow up visits. If you 
complete all the study visits, you will receive a total of $325.  
You will need to provide your Social Security Number to receive payment. 
Costs. You will not have to pay anything to be in this study. 
Sponsor. The Department of Veterans Affairs is providing financial support for this study.  
COMPENSATION for Research Related Injury 
If you are injured as a direct result of being in this study, medical treatment will be available.  If you are 
eligible for Veteran’s benefits, the cost of such treatment will be covered by the VA.  If not, the cost of 
such treatments may still be covered by the VA depending on a number of factors.  In most 
circumstances, the treatment must be provided in a VA medical facility.  No other form of compensation 
for injuries is available.  However, by signing this form you have not released the VA from liability for 
negligence.  For further information, you may call the Human Protections Administrator at (650) 493-
5000, ext. 67593 or the V.A. Regional Counsel at (415) 750-2288. 
CONTACT INFORMATION  
Questions, Concerns, or Complaints:  If you have any questions, concerns or complaints about this 
research study, its procedures, risks and benefits, or alternative courses of treatment, you should ask the 
principal investigator, Dr. Ansgar Furst, at 650-493-5000 ext. 68652.  You should also contact the 
principal investigator or any member of the research staff at any time if you feel you have been hurt by 
being a part of this study.  
Appointment Contact: If you need to change your appointment, please contact the research assistants at 
650-852-3426. 

 
RESEARCH CONSENT FORM 
 Title of Study:  Non-pharmacological treatments for insomnia in chronic traumatic brain injury     eProtocol #41040 
Principal Investigator:  Ansgar J. Furst, PhD 
VAMC: 
VA Palo Alto HCS 
 
VA Form 10-1086 
 
Page 8 of 13 
 
IRB Use Only 
Approval Date: July 31, 2023 
Expiration Date:  July 31, 2024 
If in the event of a medical emergency that may or may not be related to participation in the study please 
call 911 and notify your primary care physician.  
Independent Contact:  If you are not satisfied with how this study is being conducted, or if you have any 
concerns, complaints, or general questions about the research or your rights as a participant, please 
contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research 
team at (650)-723-5244 or toll free at 1-866-680-2906.  You can also write to the Stanford IRB, 
Stanford University, 1705 El Camino Real, Palo Alto, CA 94306. 
 
EXPERIMENTAL PARTICIPANT’S BILL OF RIGHTS 
As a research participant you have the following rights.  These rights include but are not limited to the 
participant's right to: 
• be informed of the nature and purpose of the experiment;  
• be given an explanation of the procedures to be followed in the medical experiment, 
and any drug or device to be utilized;  
• be given a description of any attendant discomforts and risks reasonably to be 
expected;  
• be given an explanation of any benefits to the subject reasonably to be expected, if 
applicable;  
• be given a disclosure of any appropriate alternatives, drugs or devices that might be 
advantageous to the subject, their relative risks and benefits; 
• be informed of the avenues of medical treatment, if any available to the subject after 
the experiment if complications should arise;  
• be given an opportunity to ask questions concerning the experiment or the procedures 
involved;  
• be instructed that consent to participate in the medical experiment may be withdrawn 
at any time and the subject may discontinue participation without prejudice;  
• be given a copy of the signed and dated consent form; and  
• be given the opportunity to decide to consent or not to consent to a medical experiment 
without the intervention of any element of force, fraud, deceit, duress, coercion or 
undue influence on the subject's decision.   
 
 
 
 
 
 

 
RESEARCH CONSENT FORM 
 Title of Study:  Non-pharmacological treatments for insomnia in chronic traumatic brain injury     eProtocol #41040 
Principal Investigator:  Ansgar J. Furst, PhD 
VAMC: 
VA Palo Alto HCS 
 
VA Form 10-1086 
 
Page 9 of 13 
 
IRB Use Only 
Approval Date: July 31, 2023 
Expiration Date:  July 31, 2024 
Current Participation in Other Studies: 
Are you participating in any other research studies? _____ Yes _____No 
Contact for Future Research Studies: 
May we contact you (by phone or letter) about related studies that may be of interest to you? 
_______ Yes. I would like to be contacted for future research opportunities. 
_______ No. Do not contact me about future research opportunities. 
 
 
Signing your name means you agree to be in this study and that you were given a 
copy of this consent form. 
 
 
 
Print Name of Participant 
 
 
 
Date 
 
 
_______ Participant provided verbal consent in lieu of signature. 
 
 
Person Obtaining Consent: 
 
 
 
Signature of Person Obtaining Consent 
 
 
 
Date 
 
 
Print Name of Person