Reduce Emotional Symptoms of Insomnia With Sleep Treatment
Phase: NA
Conditions: Insomnia, Rumination
Sponsor: Henry Ford Health System

 
 
 
 
 
 
 
 
Mindfulness-Augmented Cognitive Behavioral Therapy for 
Insomnia as a Phase 3 Treatment for Non-remittent Insomniacs 
- An Open-label Pilot Study 
NCT03724305 
March 8th 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Statistical Analysis Plan 
Study outcomes were downloaded directly from Qualtrics and all analyses were performed in SPSS 241 
version 26 (IBM Corp) with a significance value of .05. We first examined descriptive data for sample 242 
characteristics, including sociodemographics, insomnia treatment history, and presenting clinical 
symptoms. 243 Study hypotheses were tested using a complete case analysis approach, which included 
all patients enrolled in 244 MBTI. As the study was a single-arm proof-of-concept clinical trial, we 
conducted paired samples t-tests to test 245 acute pretreatment to posttreatment effects of MBTI on 
mindfulness, sleep symptoms, depression, and cognitive 246 arousal. To test long-term effects, we 
conducted paired samples t-tests comparing study outcomes at 247 pretreatment and 6-month follow-
up. Paired samples t-test effect sizes are expressed using Cohen’s dz; 248 small=.20, medium=.50, 
large=.80, very large ≥1.00. In addition, we conducted posthoc analyses to further 249 explore our data, 
which included examining frequency of Rx and OTC sleep aid use at posttreatment and 250 follow-up 
(note: reducing sleep aid use can be a goal of insomnia therapy, but this was not the case in the 251 
present study; rather we observed spontaneous changes in sleep aid use), as well as rates of insomnia 
remission 252 and major depression among patients with high vs low cognitive arousal at posttreatment 
and follow-up. 
 
2. Protocol 
1. STUDY AIM, BACKGROUND, AND DESIGN ABSTRACT  
Millions of people with untreated insomnia suffer from impaired daytime functioning, 
depression, and poor quality of life. Cognitive-behavioral therapy for insomnia (CBT-I) is a 
specialist-driven multicomponent treatment that is recommended as a first-line intervention 
with superior safety and durability relative to pharmacotherapy. Despite the demonstrated 
success of CBT-I, ~50% of patients do not achieve full remission. 
 
Our research (NINR R01 and others) suggests that inadequate CBTI response is linked to residual 
symptoms of cognitive-emotional arousal (i.e., rumination, worry) (Cheng et al., 2020; Kalmbach 
et al., 2019). Despite its role in insomnia etiology and maintenance, cognitive-emotional arousal 
is not a primary therapeutic target in standard CBTI, which has minimal effects on these 
symptoms. The link between residual cognitive-emotional arousal and treatment-resistance 
emphasizes a critical unmet need to address residual cognitive-emotional arousal symptoms in 
non-remitters. Though initial remission rates of 50-60% are good, this still leaves millions 
exposed to the harmful consequences of insomnia such as depression, daytime impairment, and 
decreased quality of life. 
 
To address this critical limitation of CBTI, researchers have placed the behavioral sleep strategies 
of CBTI into a mindfulness intervention framework to create mindfulness-based therapy for 
insomnia (MBTI).  Like CBTI, MBTI substantially reduces insomnia symptoms.  Unlike CBTI, MBTI 
also substantially alleviates cognitive arousal (Ong et al., 2008; Ong et al., 2014).  These data 
suggest that MBTI may be highly effective for treatment-resistant insomnia, which is marked by 
refractory cognitive arousal. 
 
In this internally funded pilot study, we propose to test whether MBTI significantly reduces 
symptoms of insomnia and cognitive arousal in patients with highly treatment-resistant 

insomnia.  Forty patients who did not remit after at least one round of CBTI will be recruited 
from an ongoing stepped care trial (IRB # 11586) and will receive telemedicine MBTI in this 
open-label trial.  Specifically, after patients in the stepped care trial do not fully remit after one 
(digital CBTI) or two (first-line digital CBTI followed by face-to-face in-person CBTI) rounds of 
treatment, we will invite them to participate in this trial in which all patients would receive 
telemedicine MBTI.  We will assess insomnia, cognitive arousal, and other relevant symptoms 
before and after the 8 sessions of MBTI and then again 6 months following the end of 
treatment. 
 
Aim 1: Determine whether MBTI reduces insomnia symptoms in highly treatment-resistant 
insomnia.  We predict that patients will report a significant decrease in insomnia symptoms 
from pre-MBTI to post-MBTI. 
 
Aim 2: Determine if MBTI reduces cognitive arousal in highly treatment-resistant insomnia.  We 
predict that patients will report a significant decrease in cognitive arousal symptoms from pre-
MBTI to post-MBTI. 
 
These findings would be important as they would support the hypothesis that sleep can be 
improved in a highly resistant population of insomnia patients and that this improvement may 
be due to a decrease in cognitive emotional arousal.  These findings would also allow clinicians 
to triage patients into more helpful therapies that better fit their cognitive emotional profiles 
and improve sleep and emotional well-being more quickly by targeting specific sleep issues. 
 
2. SUBJECT POPULATION AND ELIGIBILITY 
Subject Population – Inclusion criteria 
 
Previous participation in both Phase 1 and/or Phase 2 of the STRIDE (Sleep to Reduce 
Incident Depression Effectively, IRB 11586) clinical trial will serve as the recruitment 
entry point for this pilot study.  Insomnia patients (DSM-5) will have all received 
standardized digital CBTI (dCBTI) (Sleepio) (Phase1). Although most insomnia patients 
respond to dCBTI, only ~50% fully remit. dCBTI non-remitters (ISI >7) and participants 
who were then re-randomized to standard face-to-face CBTI (Phase 2), but were still 
non-remittent, will be offered mindfulness-augmented CBTI (MBTI) delivered by nurse 
via telemedicine real-time video (Phase 3). 
 
Patients who were non-remittent following face-to-face CBTI with a Behavioral Sleep 
Clinician are also eligible to participate in the study.  These would be identified using 
chart-review. 
 
No vulnerable populations will be involved, although participants who are Henry Ford 
employees will be offered the chance to participate if they meet the study criteria (still 
non-remittent for insomnia after dCBTI and/or face-to-face CBTI therapy). 
 
English literacy 
 
Participants must have access to a device (cell phone, computer, or tablet) with audio 
and video capability. 
 
Enrollment and/or Screening 
 
Participants will be identified by: 
o 2-year follow-up questionnaires from STRIDE (Sleep to Prevent Incident 
Depression Effectively, IRB 11586).  Participants must have an ISI (Insomnia 

Severity Index) > 7 at the 2-year follow-up to qualify for this pilot study. 
o Chart-review from HFHS Epic records 
 
Prospective participants will be approached by email and phone (Drake_MBTI-
STRIDE_Recruiting Materials).  No additional screening other than what has previously 
been described is necessary. 
 
    
3. STUDY PROCEDURES 
1. Potential participant is identified based on Insomnia Severity Index (ISI) score from STRIDE 
Timepoint 5 (2-year follow-up questionnaire), referral, or chart-review.  ISI score greater 
than 7. 
2. Prospective participant is contacted by email and/or phone and the additional study is 
described by the RN-Research Coordinator (RC) or Clinical Research Assistant (RA).  
Interested participants will be emailed the Informed Consent Form (ICF) in the form of a 
Qualtrics questionnaire. At the end of the Qualtrics questionnaire, the participant is given 
the option of a) Declining to participate, b) Agreeing to participate, or c) Expressing interest 
but would like more information.  A video visit will be scheduled for the latter two options. 
3. During the video visit, the RC or RA will review the ICF with the participant, explaining in 
detail the components of the study and answering all questions the participant has.  If the 
participant would still like to move forward and participate, a second ICF Qualtrics 
questionnaire will be emailed with a signature page for the participant to sign and submit.  A 
digital version of the HIPAA consent will also be discussed, and participants will be invited to 
sign.  Participants will be able to have digitally signed copies of both documents for their 
records. 
4. Once consent has been received, a baseline questionnaire (Drake_MBTI-
STRIDE_Questionnaires) will be sent by email to the participant through the Qualtrics 
platform. 
5. A tentative schedule for the 8 sessions will be determined and sent to the participant for 
reference.  Schedules are flexible and can be changed by either the participant or the nurse 
therapist as required. 
6. Eight sessions will be completed according to the Session Outlines (Drake_MBTI-
STRIDE_Session Guide).  Homework, consisting of a meditation log (Drake_MBTI-
STRIDE_Participant Handouts) and a sleep diary (Drake_MBTI-STRIDE_MBTI Sleep Diary), are 
assigned to the participant each week for completion.  Immediately prior to each session, a 
short Qualtrics questionnaire (Drake_MBTI-STRIDE_Treatment survey) will be emailed to the 
participant to complete; this questionnaire asks the participant questions about sleepiness, 
mood, and insomnia severity) to allow the clinician an opportunity to monitor the well-being 
of the participant each week. 
7. At the conclusion of the eight sessions an end-of-study questionnaire (Drake_MBTI-
STRIDE_Questionnaires) will be sent to the participant to complete. 
8. Six months after completion of the treatment sessions, a 6-month follow-up questionnaire 
(Drake_MBTI-STRIDE_Questionnaires) will be sent to the participant to complete. 
 
Additional Information 
 
Assessments will occur at baseline, at completion of the 8-week intervention, and 6 
months following completion of the intervention. 
 
Data will be collected using questionnaires on the Qualtrics survey platform for the 
following assessments at Pre-Treatment, Acute Post Treatment and then 6-Month 

Follow-up time points 
 
Insomnia Severity Index (ISI) 
 
PHQ9 
 
Five-Facet Mindfulness Questionnaire – a measure of mindfulness insight 
 
Pre-Sleep Arousal Scale (PSAS) – a measure of nocturnal cognitive arousal 
 
PSWQ – a measure of cognitive arousal 
 
RRS Brood – a measure of cognitive arousal 
 
Perseverative Thinking Questionnaire (PTQ) – a measure of repetitive negative 
thinking 
 
Epworth Sleepiness Scale (ESS) 
 
Daytime Insomnia Symptom Response scale (DISRS) 
 
COVID-19 Questions 
 
Data analysis plan: 
 
Power Analysis: Although MBTI produces large reductions in insomnia 
symptoms in prior trials (Cohen’s d > .80), patients in this study are treatment 
resistant.  Therefore, we anticipate that MBTI may have a reduced effect on 
insomnia symptoms.  Based on a medium anticipated effect (Cohen’s d = .50) 
for a two-tailed test with alpha = .05, a N = 34 sample size will have a .81 power 
to detect significant effects using within samples t-tests.  To account for 
potential subject attrition, we thus request to recruit a sample size of 40 
participants.  Notably, in many of our prior insomnia therapy trials, attrition 
rates were <5%, therefore we are confident that a N=40 sample size will provide 
sufficient power to detect symptom changes in our primary and secondary 
outcomes 
 
AIM 1: We will use an intent-to-treat approach using the last observation 
carried forward, which is a conservative method to address missing 
data/attritors in clinical trials.  We will test changes in insomnia symptoms using 
paired-samples t-tests from pre to post MBTI.  We will use a two-tailed test with 
significance set at alpha=0.05.  Cohen’s d will be used to describe effect size. 
 
AIM 2: Analyses for Aim 2 will be the same as those for Aim 1, except we will 
examine changes in cognitive arousal. 
 
The team member performing the statistical analysis will be provided with de-
identified demographic data and questionnaire answers. 
 
Therapy Content 
 
Session-by-session outlines –Drake_MBTI-STRIDE_Session Guide 
 
Participant handouts – Drake_MBTI-STRIDE_Participant Handouts 
 
 
Treatment Fidelity:   
 
For this project, Dr. Fellman-Couture will be supervised by the PI, Dr. Chris 
Drake, who is a licensed clinical psychologist with extensive training and clinical 
practice in CBTI, mindfulness-based interventions, and MBTI.  In addition, MBTI 
sessions will be audio-recorded as permitted by the participant.  After study 
completion, 5% of these sessions will be randomly selected (40*6*.05=10 
sessions) and rated for fidelity by Dr. Drake. 
 
Nurse Therapist: Cynthia Fellman-Couture, RN, PhD, is the therapist delivering the 
intervention to subjects.  In addition to providing Cognitive Behavioral Therapy for 
Insomnia as the research therapist since February, 2014, she has completed the 
following training in Mindfulness: 

 
Mindfulness-Based Stress Reduction (8-week course through the Beaumont 
Center for Mindfulness) 
 
Mindfulness-Based Cognitive Therapy (8-week course through Brown University 
School of Public Health) 
 
5-Day MBSR Silent Retreat through the Beaumont Center for Mindfulness 
 
MBSR Foundations to become a Mindfulness-Based Stress Reduction teacher (8-
week masters-level course through Brown University School of Public Health) 
which prepares individuals to begin teaching workshops in mindfulness-based 
interventions 
 
Additional certificate level training includes: 
 
MBSR: Mindfulness-Based Stress Reduction (PESI, a 2-day program) 
 
Integrating mindfulness-based stress reductions (MBSR) skills in clinical 
practice: A retreat (PESI) 
 
She has received direct training in Mindfulness-Based Therapy for Insomnia 
(MBTI) from Drs. Cheng and Drake. 
 
 
4. ANTICIPATED RISKS  
Risks include (1) excessive sleepiness and (2) rare mild emotional distress related to participants 
experiencing potentially distressing thoughts and emotions.  Mood and sleepiness are both 
monitored through weekly questionnaires, the therapy process, and sleep diaries.  Additional 
precautions include bi-weekly consultation with clinical psychologists who are part of the 
research team and one who is not directly involved in the study (P. Cheng).  Participants who 
show significant psychological distress will be removed from the study and referred to 
Behavioral Health.  Low risk-Medium benefit. 
 
5. ANTICIPATED BENEFITS 
Anticipated benefits include a new treatment option for people who have been shown to be 
resistant to sleep improvement from standard CBTI and an improvement in cognitive-emotional 
distress that may be contributing to poor sleep.  In turn, this may lower the risk of depression 
and other disorders related to poor sleep. 
 
An additional treatment option would be beneficial in that it offers hope to those who have not 
had success with other methods. 
 
 
6. RENUMERATION/COMPENSATION 
No monetary compensation will be provided. 
 
7. COSTS 
We do not anticipate there being any costs for participation. 
 
8. ALTERNATIVES 
Alternatives for taking part in this study include participants talking their doctor, getting 
treatment in a clinical setting, participating in another research study, or getting no treatment. 
 
9. CONSENT PROCESS AND DOCUMENTATION 
a. The consent will be presented in a Qualtrics questionnaire format.  At the end of the 
Qualtrics questionnaire, the participant is given the option of a) Declining to participate, b) 

Agreeing to participate, or c) Expressing interest but would like more information.  A video 
visit will be scheduled for the latter two options. 
b. During the video visit, the Research Coordinator (RC) or Research Assistant (RA) will review 
the ICF with the participant, explaining in detail the components of the study, the 
participant’s responsibilities, and answering all questions the participant has.  If the 
participant would still like to move forward and participate, the participant will be invited to 
sign the Qualtrics questionnaire.  A completed ICF will be emailed to the participant for their 
record. 
c. Prospective participants will have all the time they need to answer the questions so long as 
recruitment is still occurring. 
d. A digital copy of the consent will be stored in a password-protected folder on the HFHS 
shared drive. 
   
 
10. WITHDRAWAL OF SUBJECTS 
 
Participants may choose to withdraw from the study at any time. 
 
The PI may determine that the participant should be terminated from the study if he 
believes the study is not in the participant’s best interest. 
 
Participants may be asked to meet, virtually or in person, with study staff for safety 
reasons. 
 
If a participant withdraws or is terminated from the study, data gathered up until that 
point may be kept for analysis. 
 
11. PRIVACY AND CONFIDENTIALITY  
Research records will not include names, registration numbers, or other information that is 
likely to allow someone other than the researchers to link the information to the participant. 
The researchers will label research records with a unique code and keep any master key that 
links the participant’s name and data in a separate location. The researchers will maintain all 
study records (including any codes) in a locked, secure location. The participant’s research 
information will not be made a part of their regular medical record. All electronic files 
containing identifiable information will be password protected and only the members of the 
research staff will have access to the passwords. If researchers share the participant’s data with 
others, the information will be coded as described above to help protect the participant’s 
identity. At the conclusion of this study, the researchers may publish their findings. Information 
will be presented in summary format and the participant will not be identified in any 
publications or presentations. The participant’s identifiers will be destroyed upon completion of 
the final report. 
 
The participant’s identifiable private information or identifiable biospecimens may be stripped 
of identifiers and used for future research studies or distributed to another researcher for future 
research studies without their additional informed consent. 
 
12. DATA AND SAFETY MONITORING PLAN 
TRIAL SAFETY: All adverse events that are reported are monitored by the PI and will be 
determined for seriousness and relatedness to the study procedures.  Serious adverse events are 
immediately reported to the local IRB. 

(1) Potential Risks and Benefits for Participants 
Potential Risks: In a recent review of behavioral treatment of insomnia: “Psychological and 
Behavioral Interventions for Managing Insomnia Disorder: An Evidence Report for a Clinical Practice 
Guideline by the American College of Physicians,” psychological and behavioral interventions we 
considered low harm. However, rare and mild side effects of sleepiness, irritability, and headache 
may be reported. Thus, in order to ensure patient safety throughout the present treatment 
protocol, the following adverse event plan has been put in place to address side effects. 
Potential Benefits: The potential benefits to study participants include that participants may 
experience an improvement in their sleep and/or mood.  However, participation may not bring any 
direct participant benefit, but the medical knowledge regarding treatment of the sleep symptoms 
associated with insomnia will be advanced. 
(2)  Adverse Event, Serious Adverse Event, and Unanticipated Problem Collection and Reporting 
Definitions 
The definitions of events that will be used in this Program Project Include: 
Adverse Event (AE):   
Any untoward or unfavorable medical occurrence in a human study participant, including any 
abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally 
associated with the participants’ involvement in the research, whether or not considered related to 
participation in the research. 
Serious Adverse Event (SAE):   
Any adverse event that: 
 
Results in death 
 
Is life threatening, or places the participant at immediate risk of death from the event as it 
occurred 
 
Requires or prolongs hospitalization 
 
Causes persistent or significant disability or incapacity 
 
Results in congenital anomalies or birth defects 
 
Is another condition which investigators judge to represent significant hazards 
        Unanticipated Problem (UP):  
       Defined by DHHS 45 CFR part 46 as any incident, experience, or outcome that meets all of the 
following criteria: 
 
unexpected, in terms of nature, severity, or frequency, given (a) the research procedures that 
are described in the protocol-related documents, such as the IRB-approved research protocol 
and informed consent document; and (b) the characteristics of the study population 

 
related or possibly related to participation in the research (in this guidance document, possibly 
related means there is a reasonable possibility that the incident, experience, or outcome may 
have been caused by the procedures involved in the research) 
 
suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
       Classifying Events 
       All events occurring in this Program Project will be rated as follows:  
       Severity  
       Classifications will include the following:  
 
Mild: Awareness of signs or symptoms, but easily tolerated and are of minor irritant type 
causing no loss of time from normal activities. Symptoms do not require therapy or a medical 
evaluation; signs and symptoms are transient. 
 
Moderate: Events introduce a low level of inconvenience or concern to the participant and may 
interfere with daily activities, but are usually improved by simple therapeutic measures; 
moderate experiences may cause some interference with functioning 
 
Severe:  Events interrupt the participant’s normal daily activities and generally require systemic 
drug therapy or other treatment; they are usually incapacitating 
Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a 
severe headache is not necessarily an SAE.  However, mild chest pain may result in a day’s 
hospitalization and thus is an SAE. 
Expectedness  
AEs will be assessed as to whether they were expected to occur or unexpected, meaning not 
anticipated based on current knowledge found in the protocol or scientific literature. 
Categories are: 
 Unexpected - nature or severity of the event is not consistent with information about the 
condition under study or intervention in the protocol, consent form, product brochure, or 
investigator brochure. 
 Expected - event is known to be associated with the intervention or condition under study.   
Relatedness   
The potential event relationship to the study intervention and/or participation will be assessed by 
the site investigator. The comprehensive scale to categorize an event will be: 
 
Definitely Related:  The adverse event is clearly related to the investigational agent/procedure 
– i.e. an event that follows a reasonable temporal sequence from administration of the study 

intervention, follows a known or expected response pattern to the suspected intervention, that 
is confirmed by improvement on stopping and reappearance of the event on repeated 
exposure and that could not be reasonably explained by the known characteristics of the 
subject’s clinical state. 
 
Possibly Related:  An adverse event that follows a reasonable temporal sequence from 
administration of the study intervention, follows a known or expected response pattern to the 
suspected intervention, but that could readily have been produced by a number of other 
factors. 
 
Not Related:  The adverse event is clearly not related to the investigational agent/procedure, 
i.e. another cause of the event is most plausible; and/or a clinically plausible temporal 
sequence is inconsistent with the onset of the event and the study intervention and/or a causal 
relationship is considered biologically implausible.     
Reporting Responsibilities and Processes 
The PI, therapists, and study coordinator will be responsible for all event reporting for the project. 
They will report events to the Principal Investigator who will report events as outlined to an 
independent Data and Safety Monitoring Board. The standard definitions of AEs, SAEs, and UPs, as 
outlined above, will be used and all events will be reported to the appropriate local IRB and the 
Data Safety Monitoring Committee Chair. 
AEs, SAEs, and UPs will be collected on the enclosed forms and reported on events occurring from 
the time of consent to the time of exit interview debriefing for a given participant.  Reports will be 
conveyed by fax to the parties outlined above.  All AEs will be rated as to severity, expectedness, 
and relatedness, as defined above.  AEs will be reported within a week of the event being reported 
to the investigator, and SAEs reported within 24 hrs.  The initial SAE report will be followed up with 
a more detailed report indicating relevant additional information and event resolution when 
available.  UPs which are not SAEs will be reported within 48 hrs. of the event coming to the 
attention of the investigator and will be forwarded to OHRP within two weeks.  UP reports will 
include a corrective action plan and measures to prevent recurrence.  
(3) Protection against Study Risks 
Although the occurrence of any adverse events during MBTI is rare, participants will be asked to 
record any adverse events and will be given the phone number of the PI and study coordinator to 
report any significant concerns. In addition, at each visit all subjects will be questioned regarding any 
adverse events that have occurred since the previous contact, including sleepiness. Consenting 
procedures will also include a thorough review of the risks of performance impairment when sleepy. 
Per standard clinical and research procedures, all study participants will be advised not to drive or 
operate machinery if feeling sleepy. Participants reporting any adverse event will be followed by 
regular contact until resolution. 
All recruitment materials and the initial contact script will be submitted and approved by the 
appropriate IRB. The recruitment materials and initial contact are recognized as the first step in the 
consent process and these materials will clearly indicate that it is a research study for which 
participants are being recruited and contacted regarding study participation.  No likelihood of direct 
participant benefit will be offered in recruitment and contact materials, and the potential of risks 

will be indicated in the contacts. The participant will be given an opportunity to read the consent 
and then ask questions by phone or virtual visit about any study aspects they do not understand, at 
which point the investigator or designee will reiterate the study details and answer questions.   
Depression/suicidality: If a participant acknowledges suicidal ideation during their initial screening 
visit (i.e., via the PHQ-9), then a dedicated Henry Ford Health System process will be initiated to 
manage suicidal ideation. This protocol includes immediate assessment by an integrated behavioral 
health provider who determines the appropriate care pathway. Participants who endorse risk of 
suicide during the online study assessments will be contacted and provided an appropriate mental 
health referral and/or suicide hotline access by a Senior Staff member who is a licensed clinical 
psychologist. Thus, any high-risk participants will be provided the 24/7 crisis management hotline (1-
800-422-1183). Participants may also be referred directly to the emergency room for immediate 
admission and treatment. Additionally, we will notify the participant’s health provider (preferably 
behavioral health provider if he/she is receiving care in Behavioral Health Services). If we are unable 
to reach the participant within 24 hours of the initial phone call, we will dispatch security or law 
enforcement for a wellness check at the address provided by the participant. This protocol will be 
made clear to participants during the informed consent, which will also include the Henry Ford 
Health System’s 24/7 crisis number.  
In cases where there are clinically significant depressive symptoms present at any assessment 
participants will be contacted by sleep center clinical staff within 7 days and be directly referred to 
behavioral health services to receive care or referred to a prior mental health provider with an 
established relationship with the participant. 
Protecting the Confidentiality of Participant Data: The consent process will inform a volunteer 
about the study, indicate that their participation is voluntary and that he/she has the right to stop at 
any time. Risks will be enumerated in the informed consent document.  The informed consent 
document will be approved by the appropriate local IRB and will include all the appropriate 
elements listed in the HFHS informed consent checklist. 
Participants will be informed about all study specifics, including full confidentiality of all information, 
the security of information collected throughout the protocol, and compensation. Specifically, all 
HIPAA guidelines will be followed, including full data encryption.  Data will be analyzed and reported 
in aggregate.  Individual-level data will not be reported.  Only the PI and Research Coordinator will 
have access to these data. All PHI data will be kept in a HIPAA compliant secure password protected 
database on a secure HFHS computer. All contacts with participants will be conducted in a 
professional manner and will not impose undue pressure of any kind.  All identifying information will 
be handled with the highest degree of discretion and confidentiality. 
External: An assessment of external factors or relevant information (i.e., developments in the 
literature, results of related studies) that may have an impact on the safety of participants or on the 
ethics for the research study will be reviewed by study personnel at quarterly meetings as described 
above. Participants will be informed in a timely manner if new information becomes available that 

may be relevant to the subject’s willingness to continue participation in the study. The 
communication of this information will be documented. 
(4) INTERIM ANALYSIS 
Interim analyses of the proposed project are not planned.  The interventions used in this study are 
not investigational and present low risk to the study participants.  The behavioral treatments are 
treatments previously investigated with no AEs or SAEs reported in those studies or they are 
treatments with low risks used in clinical sleep centers throughout the US.  
 
13. QUALIFICATIONS OF THE INVESTIGATOR(S) 
a) Christopher Drake, PhD, (Principal Investigator) is a Clinical Psychologist at the Thomas 
Roth Sleep Disorders & Research Center and Associate Professor of Psychiatry and 
Behavioral Neuroscience, School of Medicine, Wayne State University in Detroit. Dr. Drake 
completed a two-year fellowship at the National Institute of Mental Health, Clinical 
Psychobiology Branch in 1994 and is board-certified in Sleep Medicine and Behavioral 
Sleep Medicine.  He is the Associate Editor for the journal SLEEP and serves on the editorial 
board for the journals Behavioral Sleep Medicine, World Journal of Neurology, and The 
Open Sleep Journal.  Dr. Drake has served as a member of the Board of Directors for the 
National Sleep Foundation.  As well as serving on other national committees, Dr. Drake 
served as Section Head of Sleep Disorders Research for the Sleep Research Society from 
2005 to 2006 and has been an advisor to the World Health Organization on sleep.  He has 
authored numerous publications in the field of sleep medicine and serves as a reviewer for 
18 scientific journals.  Dr. Drake recently completed a study funded by the National 
Institute of Health to study the efficacy of Cognitive Behavioral Therapy for Insomnia as a 
treatment for insomnia concurrent with menopause.  He has also recently completed a 
federally-funded study on predisposition to chronic insomnia. Currently, Dr. Drake is 
funded by the National Institute of Mental Health to investigate the efficacy of Cognitive 
Behavioral Therapy for Insomnia in preventing the development of depression. In addition 
to his federal funding, Dr. Drake has received numerous pharmaceutical grants from 
companies such as Pfizer, Cephalon Inc., Takeda Pharmaceuticals, and Sanofi-Synthelabo 
to conduct Phase 2, 3, and 4 clinical trials. His areas of expertise include insomnia, 
excessive sleepiness, and sleep deprivation. 
b) Philip Cheng, PhD, (Co-Investigator) is a well-published clinical psychologist who has 
maintained an active and federally funded research program  in sleep and circadian 
rhythms.  He took a leadership in the design, implementation, data collections, data 
anylisis, and publication of the previous trial that this research proposal is built on.  He has 
published numerous first author papers from the prior study, with additional manuscripts 
in preparation. 
 
14. REFERENCES 
 
Cheng, P., Kalmbach, D. A., Castelan, A. C., Murugan, N., & Drake, C. L. (2020). Depression 
prevention in digital cognitive behavioral therapy for insomnia: Is rumination a mediator? 
Journal of Affective Disorders, 273, 434-441. 
 
Kalmbach, D. A., Cheng, P., Arnedt, J. T., Anderson, J. R., Roth, T., Fellman-Couture, C., ... & 
Drake, C. L. (2019). Treating insomnia improves depression, maladaptive thinking, and 
hyperarousal in postmenopausal women: comparing cognitive-behavioral therapy for 

insomnia (CBTI), sleep restriction therapy, and sleep hygiene education. Sleep medicine, 55, 
124-134 
 
Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of 
mindfulness meditation for chronic insomnia. Sleep. 2014;37(9):1553-1563. 
 
Ong JC, Shapiro SL, Manber R. Combining mindfulness meditation with cognitive-behavior 
therapy for insomnia: a treatment-development study. Behavior therapy. 2008;39(2):171-
182. 
 
Zoccola, P. M., Dickerson, S. S., & Lam, S. (2009). Rumination predicts longer sleep onset 
latency after an acute psychosocial stressor. Psychosomatic Medicine, 71, 771–775. 
doi:10.1097/PSY.0b013e3181ae58e8