Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Program of Cognitive-Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients
Phase: NA
Conditions: Insomnia
Sponsor: Columbia University

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted 
Digital Program of Cognitive-Behavioral Therapy for Insomnia for Spanish 
Speaking Latina/o Primary Care Patients  
National Clinical Trial (NCT) Identified Number:  NCT05353296
Principal Investigator: Carmela Alcántara, PhD 
Sponsor: Columbia University 
Grant Title: Dormir Mejor Study: Randomized Controlled Trial of a Culturally 
Adapted Digital Program of Cognitive-Behavioral Therapy for Insomnia for 
Spanish Speaking Latina/o Primary Care Patients   
Grant Number: HS024274 
Funded by: Agency for healthcare Research and Quality/Department of 
Health and Human Services 
Protocol Date: 18 May 2022 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP) and the following:  
•
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).
All National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible 
for the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form. 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS 
Title: 
Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted 
Digital Program of Cognitive-Behavioral Therapy for Insomnia for Spanish 
Speaking Latina/o Primary Care Patients 
Grant Number: 
HS024274 
Study Description: 
This a parallel-group, single-site, 2-arm Hybrid Type-1 effectiveness-
implementation study . We will enroll 200 adults with positive chronic 
insomnia screen into a superiority randomized controlled trial to compare the 
effectiveness of a culturally-adapted Spanish-language digital program of CBT-I 
called Somryst (+ usual care, and sleep hygiene brochure) versus minimally 
enhanced usual care (mEUC) (usual care + sleep hygiene brochure). Follow-up 
assessments of insomnia symptoms and of secondary outcomes will be 
conducted at post-intervention (9 weeks) and 6 months follow-up by a staff 
member blinded to group assignment. Sleep duration and sleep efficiency will 
be assessed with actigraphy at baseline (prior to randomization) and at post-
intervention (9 weeks). Patients will be randomly assigned in a 1:1 ratio to 
either the Culturally Adapted digital CBT-I program (Somryst) or minimally 
Enhanced Usual Care (mEUC) condition. Randomization will be generated by a 
computerized random-number sequence and held by the study statistician. 
The sequence will be unknown to research assistants enrolling patients. Our 
primary hypothesis is that patients randomized to the Somryst treatment 
condition will experience a greater improvement (from baseline) in the 
Insomnia Severity Index (ISI) at post-intervention (9 weeks) compared to those 
randomized to mEUC, and scores will continue to be better than mEUC 
patients at 6 months post-intervention. The null hypothesis is that there will 
be no difference in the ISI scores between patients randomized to the Somryst 
treatment versus those assigned to mEUC. 
Objectives: 
The primary objective of the proposed study is to examine the effectiveness of 
a culturally adapted digital CBT-I program compared to minimally enhanced 
usual care (mEUC) on primary outcomes: reduction in insomnia symptoms at 9 
weeks, and 6 months post-intervention using a standard scale. Secondary 
outcomes will include quality of life, daytime sleepiness, satisfaction with care, 
sleep quality, and self-reported and actigraphy-assessed wake after sleep 
onset as well as self-reported sleep onset latency at post-intervention. 
Exploratory outcomes will include actigraphy-assessed sleep duration and sleep 
efficiency.  

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
Endpoints: 
Primary Endpoint: Insomnia symptoms will be assessed at baseline, at 9 weeks 
(post-intervention) and at 6 months post-intervention follow-up using the ISI. 
Secondary Endpoints: Health-related quality of life will be assessed through 
the validated Short-Form 12 (SF-12), Day time sleepiness will be measured 
with the 8-item Epworth Sleepiness Scale at baseline, at  9-weeks, and 6-
months; Satisfaction with care will be measured using a question adapted for 
this trial asking patients to rate the quality of professional care they have 
received for their symptoms of insomnia at post-intervention and 6 -months; 
Wake after sleep onset will be measured with self-report and actigraphy, and 
sleep onset latency will be measured with self-report at post-intervention.  
Sleep quality will be measured with the PSQI at baseline, 9 weeks, and 6-
months. Sleep duration and sleep efficiency will be measured continuously 
and unobtrusively for 14 days at baseline and for 14-days post-intervention 
using the ActiWatch SpectrumPRO, an actigraphy-based device. 
Study Population: 
Two hundred Latina/o adult patients from primary care clinics affiliated with 
Columbia University Irving Medical Center and New York Presbyterian Hospital 
(the Ambulatory Care Network) that serves underserved communities across 
New York City will be enrolled into the study. Patients will be Spanish speaking 
or bilingual (English and Spanish) adults with moderate to severe insomnia 
symptoms as documented on initial eligibility screen, who are interested in 
receiving digital care to improve their insomnia in Spanish.  
 
Phase III trial  
 
Phase or Stage: Description 
of Sites/Facilities Enrolling 
Participants: 
Patients will be recruited through flyers, email, telephone, and primary care 
provider referrals from primary care clinics affiliated with Ambulatory Care 
Network (ACN) of New York Presbyterian Hospital (NYPH). The catchment areas 
are the ACN clinics of NYPH, which serve 1.4 million individuals in NYC, including 
low socioeconomic and racially/ethnically diverse communities in NYC such as 
Washington Heights, Inwood, Harlem, and the Southwest Bronx, as well as 
geographically broader communities, including Queens. This is a single-site 
study and the site is not outside of the United States. 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
Description of Study 
Intervention/Experimental 
Manipulation: 
Study candidates who meet initial eligibility criteria and consent to participate 
will be invited for an online virtual or in-person visit  dependent on participant 
preference where they will complete a baseline sociodemographic and 
psychosocial survey battery, and be asked to complete a daily sleep diary for 
14 days and to wear an actigraph (Actiwatch) that will be mailed to them to 
capture continuous objective sleep data on sleep duration and sleep efficiency 
for 14 days. Participants will be asked to return their actiwatch via mail. After 
completing the baseline assessment, patients will be randomly assigned in a 
1:1 ratio to either the intervention condition (Somryst) or the comparator 
condition (Minimally Enhanced Usual Care (mEUC). Patients in the intervention 
group will receive the culturally adapted digital CBT-I (Somryst), usual care by 
their PCP and a sleep hygiene brochure. Patients will also be trained on how to 
record their daily sleep diaries using a smartphone diary; and will receive 
prompts on their smartphones or emails to remind them when to complete 
the daily sleep diaries. Patients randomized to the control group will receive 
minimally enhanced usual care (mEUC), which will include the usual care 
provided by their PCP, and an informational brochure on sleep hygiene. 
Patients in both groups will have their insomnia severity assessed again at  9-
weeks post-intervention and at 6-months follow-up. Patients in both groups 
will also wear the Actiwatch Spectrum Pro to objectively assess sleep for 2 
weeks after enrollment and again at the post-intervention assessment.  
8 months 
 
Study Duration: 
Participant Duration: 
8 months 
1.2 
SCHEMA 
Figure 1. Flow Diagram of RCT Study Design 
Pre-Screening 
Total N: 378 
Pre-screen potential participants by inclusion and exclusion criteria; schedule Visit 1. 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
Day -30 to Day 1 
Visit 1 
Day 1 
Visit 2 
Day 3 ± 2 
Visit 3 
Day 17 ± 2 
Visit 4 
Day 80 ± 2 
Visit 5 
Day 80 ± 2 
Visit 6 
Day 248 ± 2 
Conduct informed consent process. Perform baseline assessments  N: 
Refer to Section 1.3, Schedule of Activities 
Final 6 -month post-intervention 
follow-up Assessments 
refer to Section 1.3, Schedule of 
Activities 
mEUC 
N = 100 
digital CBT-I 
N = 100 
9-week post-intervention assessment 
Randomize 
Administer 14-day post-intervention assessment (actigraphy + sleep diary) 
Administer 14-day pre-treatment sleep assessment (actigraphy + sleep diary) 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
1.3 
SCHEDULE OF ACTIVITIES 
After the cultural adaptation of Somryst developed in study 1, we will then enroll 200 patients into the 
RCT to compare the effectiveness of the culturally adapted digital program of CBT-I (Spanish Somryst) to 
minimally enhanced usual care and to determine cost-effectiveness of the intervention. Summary data 
from our pilot study indicate that 94 people were screened over 6 months, 52% were found eligible, and 
71% completed the study. In particular, our screening in one primary care clinic over two months 
resulted in 22 people screened, 77% were eligible, and 71% completed the first focus group. Our pilot 
data indicate that we are able to screen 8 patients/month and enroll patients/month from one clinic and 
that an accrual rate of 12/month from multiple clinics is reasonable. The specific list of measures and 
schedules of activities are represented in Table 1.  
Table 1. List of Measures and Schedule of Activities 
Screening/ 
Enrollment 
Baseline 
Pre-Tx 
Treatment 
 Post-Tx 
(9 
weeks) 
 6-mo 
Follow
-Up 
Procedure/Assessment/Follow
-Up Windows 
Virtual  or in 
person 
Virtual or in 
person 
14 days 
before tx 
Through 
Week 9 of 
Study 
 Post-Tx 
(9 
weeks) 
 6-mo 
Post-
Tx 
Sociodemographic information 
X 
Insomnia Severity Index 
X 
X 
X 
X 
X 
Informed Consent/Enrollment 
X 
Permission for Future Contact 
and Use 
X 
Sleep and Depression 
Medicines 
X 
X 
X 
Sleep Disorder 
X 
CAGE Assessment 
X 
Assessment for 
Bipolar/Psychosis/ 
Schizophrenia 
X 
Health Care Coverage 
X 
Assessment for Cognitive 
Impairment 
X 
Language Proficiency 
X 
Technology Use 
X 
Referral/Contact Information 
X 
Randomization 
X 
Generalized Anxiety Disorder 
(GAD-7) 
X 
X 
X 
X 
Epworth Sleepiness Scale (ESS) 
 X 
X 
X 
X 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
Pittsburgh Sleep Quality Index 
(PSQI) 
X 
X 
X 
Quality of Life (SF-12) 
X 
X 
X 
Satisfaction with Care (PACIC) 
X 
X 
X 
Health Literacy 
X 
Penn State Worry 
Questionnaire (PSWQ) 
X 
Personal Health Questionnaire 
Depression Scale (PHQ-8) 
X 
X 
Health Care Utilization 
X 
X 
X 
Medical History 
X 
Dysfunctional Attitudes and 
Beliefs about Sleep (DBAS-16) 
X 
X 
X 
Hospitalization 
X 
X 
Acceptability and satisfaction 
with intervention 
X 
Actigraphy 
X 
X 
Usability and Net promoter 
questionnaire  
Xa 
Sleep Diary 
X 
X 
Adverse Events 
X 
X 
X 
Notes: aUsability and Net promoter questionnaire will be asked once at the beginning of the post-tx actigraphy 
assessment period and will only be included for those who were randomized for Somryst treatment  

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
2 
INTRODUCTION 
2.1 
STUDY RATIONALE 
Chronic insomnia—dissatisfaction with sleep quantity or sleep quality that is associated with difficulty 
initiating or maintaining sleep, or waking too early, and with impaired daytime functioning for at least 
three months— is a national public health problem.1,2 It is the most prevalent sleep disorder in the US and 
is associated with poor health, increased risk of death, and significant economic costs.3–5 Over 30 million 
US adults and nearly 20% of primary care patients suffer from chronic insomnia.6–9 Importantly, the 
prevalence of insomnia is significantly higher in Hispanics (26.5%) than non-Hispanic Whites (22.5%),10 
and this disparity is widening over time.10  
National polls suggest that 20% of adults seek treatment from a health care provider to manage their 
insomnia, and primary care providers commonly serve as the first source of treatment.11,12 Cognitive 
behavioral therapy for insomnia is a robustly effective psychological intervention for treatment of 
insomnia with sustained benefits,13,14 and is recommended over medications as the first-line treatment 
for chronic insomnia.15–17 Unfortunately, few receive this standard of care. Further, pharmacotherapy far 
exceeds use of CBT-I despite provider concerns about adverse effects from medications and patient 
preference for behavioral treatments.17–20 Hispanics, and particularly those with limited English 
Proficiency, are even less likely than non-Hispanic Whites to have access to high quality evidence-based 
behavioral health care such as CBT-I, 21–23 primarily because of the lack of available qualified bilingual 
behavioral providers trained to deliver CBT-I in Spanish and costs.24 Given the increasing prevalence of 
insomnia among Hispanics, and the linguistic realities of today’s behavioral healthcare work force, the 
demand for bilingual behavioral health providers equipped to deliver CBT-I in Spanish significantly 
outweighs the supply. Advances in health information technology such as self-guided digital treatments 
represent an innovative and scalable means to address the supply and demand imbalance that 
perpetuates mental health care disparities; however, its implementation in underserved communities 
remains elusive.  
Recent technological advances in ehealth or digital health demonstrate great promise for improving 
access to CBT-I: self-guided CBT-I delivered via an online web-based platform is as effective as CBT-I 
delivered in-person.25–32 However, the randomized controlled trials (RCTs) that tested the effectiveness of 
digital versions of CBT-I were conducted outside of the primary care context in English-fluent, high 
socioeconomic status (SES), high health literacy, and non-Hispanic White samples.33–35 As such, extant 
digital programs of CBT-I have not been adapted for use among these underserved patient populations. 
Further, data on the barriers and facilitators of implementation of these digital behavioral treatments in 
underserved racial/ethnic minority populations were rarely collected or used to support its integration 
into primary care. 
This proposed study will use a Hybrid trial type 1 effectiveness-implementation study design that 
leverages recent technological advances in digital health  to enroll 200 Spanish-speaking Hispanic primary 
care patients with chronic insomnia into an RCT that compares the effectiveness of a culturally adapted 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
digital program of CBT-I with enhanced usual care for insomnia. We will also concurrently assess the 
implementation context using a mixed methods approach. 
2.2 
BACKGROUND 
Chronic insomnia is a national public health problem. It is the most prevalent sleep disorder in the United 
States (US), and is defined as dissatisfaction with sleep quantity or sleep quality that is associated with 
difficulty initiating or maintaining sleep, or waking too early, and is accompanied by impaired daytime 
functioning for at least three months.1,2 Over 30 million Americans (10%),3,4 and nearly 20% of primary 
care patients6,7,36,37 suffer from chronic insomnia, which persists for at least 3 years in 50-85% of those 
with the condition.37–39 Chronic insomnia also exerts a significant toll on the US economy. Over $14 billion 
dollars are spent annually on direct costs associated with insomnia-attributable health care services or 
sleep aids,3,18 and insomnia is associated with higher rates of health care utilization (both medical and 
psychiatric care), daytime impairment, and occupational impairment.3,7,18 Indirect costs associated with 
insomnia are as high as $28 to $57 billion, when considering lost workplace productivity due to 
absenteeism and presenteeism (attending work even while sick, fatigued), accidents, and reduced quality 
of life.3,40–42 
Chronic insomnia is associated with poor health and increased risk of death. Insomnia is linked to 
increased risk of incident hypertension, metabolic syndrome, myocardial infarction, stroke,3,18,43–48 and 
cardiovascular and all-cause mortality.43,49 Insomnia also has a bidirectional association with psychiatric 
disorders. In many cases, insomnia co-occurs with, results from, or precedes the onset of depression and 
anxiety.50–54 For example, over 33% of people with insomnia also have a mental disorder.4 
Latina/os bear greater risk of chronic insomnia and sociocultural stressors may be important determinants 
of insomnia for Hispanic adults. Importantly, the prevalence of insomnia is significantly higher among 
Hispanics (26.5%) than non-Hispanic Whites (22.5%),55 and this disparity is widening over time.10 Temporal 
analyses using the National Health Interview Survey indicate that the age-adjusted prevalence of insomnia 
among Hispanic/Latino adults was 16.6% in 2002 compared to 19.3% in 2012.10 Additionally, analyses of 
over 5,000 participants in the Hispanic Community Health Study/Study of Latinos indicates that 
acculturative stress, or the stress associated with integration and adaptation to the US mainland, is 
strongly predictive of insomnia severity (Exp(b)=1.15 (95% CI: 1.11, 1.18).56 As such, resolution of 
acculturative stress may be an important intervention target in behavioral treatments for insomnia 
targeting Hispanics. 
Chronic insomnia is undertreated in the usual primary care setting. National polls suggest that 60% of 
adults take some action to manage their insomnia while the remaining 40% do nothing at all or assume it 
will go away with time.11,12 Only 20% of adults seek treatment from a health care provider for their 
insomnia, and primary care providers serve as the first source of treatment.11,12,40 However, primary care 
providers often consider insomnia to be secondary to other psychological or physical health issues, and 
behavioral treatments for insomnia are rarely considered or available.57,58 Indeed, a recent review 
identified a number of primary care provider barriers to insomnia treatment including: inadequate 
training, time-constrained office visits, lack of discussion of sleep issues, inaccurate beliefs by both 
patients and providers about the importance of sleep problems, the perception among providers that 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
insomnia treatments are ineffective and associated with significant risks, and the lack of a research base 
showing that treatment of insomnia improves outcomes and co-morbid conditions.18 These barriers 
contribute to an overall underdiagnosis and undertreatment of chronic insomnia in the primary care 
setting.18 
Cognitive behavioral therapy for insomnia (CBT-I), a robustly effective psychological treatment with large 
effect sizes and proven long-term benefit over medications, is the recommended first-line of treatment 
for insomnia. Pharmacotherapy (benzodiazepine receptor agonists and non-benzodiazepines [sedating 
antidepressants]) and CBT-I are two treatments with considerable evidence to support their effectiveness 
in the clinical management of insomnia.38 Numerous RCTs and meta-analyses have shown that, for the 
average patient included in these trials, pharmacotherapy and CBT-I are effective, at least in the short 
term.33,37,59–62 Pharmacotherapy offers more immediate symptom relief over the first 10 days, but does 
not, on average, maintain these improvements after medication is discontinued.38 In contrast, CBT-I, 
which combines cognitive therapy to address maladaptive beliefs and expectations about sleep, with 
behavioral treatments (e.g., sleep restriction, stimulus control), often implemented over 6-8 weeks, 
results in more sustained benefits over time; CBT-I also has large effect sizes (e.g., wake after sleep onset 
improved by 26 minutes (95%CI: 15.48, 36.52).13,14,38,63 Thus, clinical guidelines and systematic reviews 
encourage a trial of CBT-I first before pharmacotherapy is initiated.38,64 
Use of pharmacotherapy far exceeds use of CBT-I for the treatment of chronic insomnia in the primary 
care setting despite growing evidence for major adverse drug effects from sleep medications.16 Use of the 
commonly prescribed hypnotic, zolpidem tartrate (Ambien), was implicated in 11.5% of adult psychiatric 
medication adverse drug emergency department (ED) visits in 2009-2011, a rate which was markedly 
higher than that of any other drug.65 Zolpidem was also implicated in 32.1% of all psychiatric medication 
ED visits for falls or head injuries.65 Concerns about sleep medication side effects – dependence, and 
adverse drug events – loom large among both patients and primary care providers.18 Importantly, when 
offered a choice, up to 75% of patients prefer behavioral treatments over pharmacotherapy for the 
treatment of psychiatric disorders such as insomnia.17 Thus, there is an urgent need to expand access to 
evidence based and patient-preferred alternatives to pharmacotherapy for insomnia in the primary care 
setting. 
Latina/os are less likely to have access to high quality behavioral health care, such as CBT-I, and this is 
especially true for Spanish-speakers. On average, Hispanics receive lower quality mental health care than 
their non-Hispanic White counterparts.21–23 Limited English proficiency patients experience greater 
barriers to receipt of comprehensive behavioral health care. Indeed, 20% of Spanish speakers do not seek 
healthcare because of language barriers.22 Given the rise of insomnia among Hispanics, and the linguistic 
realities of today’s behavioral healthcare work force, the demand for bilingual behavioral health providers 
equipped to deliver CBT-I in Spanish significantly outweighs the supply. 
While cognitive-behavioral therapy for insomnia is a robustly effective treatment with structured core 
components that can be adapted and tailored for use among underserved populations, no extant studies 
of CBT-I have targeted Spanish speakers. We conducted a systematic review of behavioral treatments for 
sleep problems to determine whether these treatments were adapted for vulnerable populations. Of the 
22 studies included, 8 focused on insomnia and only 5 contained some form of adaptation. Modifications 
included accommodating the setting and length of the intervention. No modifications were made for 
Spanish language or other sociocultural factors. Yet, racial/ethnic and language minorities who receive a 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
culturally adapted intervention versus an unadapted intervention exhibit superior treatment and 
retention outcomes.66,67 
Limited access and high cost are key barriers to the wide implementation of in-person CBT-I in primary 
care. A lack of awareness, limited availability of qualified behavioral providers, and the high cost of CBT-I 
have impeded its uptake in primary care.18 Indeed, “could not afford cost” is often cited as the most 
common reason among adults aged 18 and older for not receiving mental health services.68 Primary care 
providers are also not well informed about how to refer their patients for behavioral interventions. Thus, 
there is a pressing need for low-cost, scalable behavioral interventions for chronic insomnia.  
The RCTs testing CBT-I excluded Spanish-speakers. Many of the RCTs testing CBT-I had stringent inclusion 
criteria and were conducted in academic research centers, among patients with high socioeconomic 
status (mean education is 16.4 years) and with high levels of health literacy and numeracy.33,34,69,70 The 
RCTs that were conducted in community settings 71–73 often did not include active comparators, were 
underpowered,71 or did not include Spanish speakers.35,74  
Although recent technological advances in e-health show great promise for improving access to CBT-I, 
most of these interventions have not been implemented in underserved racial/ethnic communities such 
as Hispanic communities. Internet-based CBT-I produces reductions in insomnia that are comparable to 
those achieved through in-person CBT-I.25,29–32 However, none of the extant digital CBT-I platforms are 
available in Spanish. Behavioral interventions that leverage recent advances in e-health may be able to 
capitalize on the increasing rates of Internet use among Hispanic US adults to close this behavioral 
healthcare access gap, and address mental health care disparities. Indeed, Internet penetration among 
Hispanics in the US is at an all-time high, with 51% of Spanish-speaking and English-speaking Hispanic 
adults aged 18 and older reporting accessing the Internet via broadband at home, compared to 66% of 
non-Hispanic Whites.75 Hispanics also have mobile devices such as smartphones and tablet computers in 
shares similar to Whites76 and Hispanics are more likely than Whites to use their smartphones to access 
health information.76 Advances in health information technology such as self-guided digital treatments 
represent an innovative and scalable means to address the supply and demand imbalance that 
perpetuates mental health care disparities; however its implementation in underserved communities 
remains elusive. 
The specific barriers and facilitators for the successful implementation of digital CBT-I for Spanish speakers 
in primary care are unknown. While recent efforts within the Veterans Health Administration have 
focused on the implementation of in-person CBT-I,24 no studies to date have conducted an assessment of 
the implementation context for digital treatments for insomnia. Further, data on the barriers and 
facilitators of implementation of these digital behavioral treatments in underserved racial/ethnic minority 
populations were rarely collected or used to support its integration into primary care. Emergent hybrid 
effectiveness-implementation study designs77 offer great promise for the formal conduct of comparative 
effectiveness research and the identification of organizational, provider, and patient implementation 
factors that may affect successful integration of digital CBT-I. For example, this study design will allow us 
to assess treatment acceptability, providers’ engagement with intervention implementation, patients’ 
intervention self-efficacy, and compatibility of intervention with healthcare setting priorities. 
2.3 
RISK/BENEFIT ASSESSMENT 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
2.3.1 KNOWN POTENTIAL RISKS 
This study poses low risk of physical harm to participants. There may be immediate risks stemming from 
minimal discomfort from answering surveys about topics that are sensitive and personal in nature, and 
from wearing the Actiwatch that tracks sleep, but these are generally mild and go away quickly. 
Additionally, participants may experience initial tiredness/fatigue from the sleep restriction component 
of the intervention. Lastly, in taking part in the study there is the possibility of a loss of confidentiality or 
privacy. 
2.3.2 KNOWN POTENTIAL BENEFITS 
Immediate and long-term potential benefits include that participants randomized to the treatment arm 
will receive an interactive digital intervention designed to primarily improve insomnia and secondarily, 
health-related quality of life. Participants randomized to the minimally enhanced usual care control group 
will initially receive more information about the diagnosis and symptoms of insomnia in addition to 
information on sleep hygiene.  
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
We are balancing the risk of discomfort in answering personal questions and from wearing the Actiwatch, 
the risk of increased sleepiness during sleep restriction for the intervention participants and risk of breach 
of privacy and confidentiality against testing a culturally adapted digital treatment for insomnia that could 
expand access to the gold standard of care for insomnia to Spanish-speaking adults at a reduced cost.  
The risks to participants in this study are low. All participants will be informed that their responses are 
confidential, that they may end their participation at any time without explanation, and that ending their 
participation will in no way affect their future interactions with their health care providers or the study. 
To protect against risk, we will first obtain permission to participate from patients’ PCPs before conducting 
study activities. We will emphasize to participants that they can discontinue the study interventions at 
any point during the trial.   
The risk of loss of confidentiality will be minimized by securely storing data and minimizing the use of PHI. 
To ensure confidentiality, all data containing personal identifiers, used to track contact with patients, will 
be kept in a secure, password-protected, encrypted tracking program developed by the Data 
Management Unit (DMU) in the Department of Biostatistics in Columbia University’s Mailman School of 
Public Health. DMU data systems have been certified by Columbia University Medical Center IT as secure 
for the storage of both research and patient care data. As part of this certification, the systems are audited 
regularly for security and regulatory compliance. Certification is based on HiTrust standards 
(https://hitrustalliance.net/benefits-hitrust-certification/). No paper documents with personal identifiers 
will be kept. Data collected via the smartphone app will be transmitted to a secured server that meets all 
HIPAA and other regulatory body requirements. Files downloaded from the web program will be stored 
on an encrypted study laptop and be password-protected. Study staff are assigned a user ID and password 
to assess the web program. Only the PI and research personnel listed on the study protocol will have 
access to the file password. No hardcopy data will be stored. The PI will be responsible for ensuring that 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
the confidentiality of the data is maintained at all times. All data will be obtained specifically and 
exclusively for research purposes. 
The knowledge gained will help determine whether the culturally adapted digital intervention is effective 
at reducing insomnia symptoms compared to usual care. If effective, the dissemination of this intervention 
will greatly increase access to the first-line, evidence-based insomnia treatment in a primary care setting 
serving underserved patients, will reduce the burden of disease from chronic insomnia, and will reduce 
unnecessary adverse consequences of sleep medications for one of the fastest growing segments of the 
US population. 
3 
OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary 
The primary objective of the 
proposed study is to examine 
the effectiveness of a culturally 
adapted digital CBT-I program 
compared to minimally 
enhanced usual care (mEUC) on 
reduction in insomnia symptoms 
at post-intervention (9 weeks), 
and 6 months post intervention 
using a standard scale.  
Change in insomnia 
symptoms 
(measured with the 
Insomnia Severity 
index) from baseline 
to post-intervention 
(9 weeks) and at 6 
months post-
intervention will 
serve as the primary 
endpoints. 
Insomnia symptoms is the 
primary endpoint given that the 
intervention targets amelioration 
of insomnia symptoms.   
Secondary 
Health-related quality of life 
Change in mean 
health-related 
quality of life score 
from baseline to 
post-intervention (9 
weeks) will serve as 
a secondary 
endpoint. Health 
related quality of life 
will be assessed 
through the 
validated Short-Form 
12 (SF-12), which is a 
12-item self-report 
Quality of life is included as a 
secondary endpoint because in 
Aim 2 Economic analyses will 
compare differences in mean 
health-related quality of life 
utilities (derived from SF-12 
scores).  

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
inventory that 
generically measures 
quality of life; it 
yields a measure of 
global health-related 
wellbeing as 8 
domain-specific 
subscores.82  
Daytime sleepiness 
Change in mean 
daytime sleepiness  
from baseline to  
post-intervention (9 
weeks) follow-up will 
serve as a secondary 
endpoint. Sleepiness 
will be measured 
with the 8-item 
Epworth Sleepiness 
Scale, a brief, 
validated self-report 
scale of daytime 
sleepiness with 
excellent 
psychometric 
properties.83  
Satisfaction with care 
Change in mean 
satisfaction with 
care from baseline 
to post-intervention 
(9 weeks) will serve 
as a secondary 
endpoint. 
Satisfaction with 
care will be 
measured using a 
question adapted for 
this trial asking 
patients to rate the 
quality of 
professional care 
they have received 
for their symptoms 
of insomnia.85  
Self-reported and actigraphy 
assessed wake after sleep onset. 
Change in mean 
wake after sleep 
onset from baseline 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
post-intervention (9 
weeks) will be a 
secondary endpoint. 
Self-reported wake 
after sleep onset will 
be recorded in a 14-
day sleep diary and 
refers to the self-
reported total 
number of minutes 
participants spent 
awake after they fell 
asleep. Actigraphy 
assessed wake after 
sleep onset will be 
measured with 14-
days of wrist-
actigraphy and 
refers to the total 
number of minutes 
participants spent 
awake after they fell 
asleep. Range: 24 
hours Minimum 
value = 0 minutes 
(better) Maximum 
value = 1440 
minutes (worse) 
Self-reported sleep onset 
latency 
Change in sleep 
onset latency from 
baseline to post 
intervention (9 
weeks). Sleep onset 
latency will be 
recorded in a 14-day 
sleep diary and 
refers to the number 
of minutes that it 
takes participants to 
fall asleep. Range: 24 
hours Minimum 
value = 0 minutes 
(better) Maximum 
value = 1440 
minutes (worse) 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Sleep quality 
Change in sleep 
quality from baseline 
to  post-intervention 
(9 weeks) will serve 
as a secondary 
endopoint. Sleep 
quality will be 
measured with the 
Pittsburgh Sleep 
Quality Index (PSQI), 
which has strong 
psychometric 
properties and is 
validated in Spanish. 
Tertiary/Exploratory 
Actigraphy assessed sleep 
duration and sleep efficiency 
Change in actigraphy 
assessed sleep 
duration and sleep 
efficiency from 
baseline to post-
intervention (9 
weeks). Sleep 
duration and sleep 
efficiency will be 
measured 
continuously and 
unobtrusively for 14 
days at baseline and  
post-intervention (9-
weeks) assessment 
using the ActiWatch 
SpectrumPRO, a 
waterproof, 
lightweight, 
actigraphy-based 
device that 
measures physical 
activity continuously 
and can be worn for 
24 hours daily. The 
validity of actigraphy 
for determining 
sleep duration in 
particular, compared 
with the gold 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
standard 
polysomnography, is 
excellent.59  
4 
STUDY DESIGN 
4.1 
OVERALL DESIGN 
We will use a Hybrid trial Type 1 effectiveness implementation study design77 and a mixed methods 
approach to compare the effectiveness of culturally adapted-Somryst (+ usual care and a sleep hygiene 
brochure)  vs. minimally enhanced usual care (mEUC; usual care plus sleep hygiene brochure). This is a 
parallel-group, single-site, 2-arm study. 
Patients will be recruited through flyers, email, telephone, and primary care provider referrals from 
primary care clinics affiliated with Ambulatory Care Network (ACN) of New York Presbyterian Hospital 
(NYPH). The catchment areas are the ACN clinics of NYPH, which serve 1.4 million individuals in NYC, 
including low socioeconomic and racially/ethnically diverse communities in NYC such as Washington 
Heights, Inwood, Harlem, and the Southwest Bronx (31% African American; 61% Hispanic descent), as well 
as geographically broader communities, including Queens (11% African American; 25% Hispanic; 11% 
Asian/Pacific Islander).  
We will enroll 200 adults who screen positive for chronic insomnia into an RCT that will compare the 
effectiveness the culturally-adapted digital CBT-I (Somryst) program versus minimally enhanced usual care 
(mEUC). Participants in the intervention arm will receive digital CBT-I, usual care by their PCP and a sleep 
hygiene brochure. Patients in the intervention group will also be trained on how to record their daily sleep 
diaries using a smartphone and will receive prompts on their smartphones or emails to remind them when 
to complete the daily sleep diaries. Patients randomized to the comparator group will receive minimally 
enhanced usual care, which will include usual care by their PCP and a sleep hygiene brochure. Patients in 
both groups will have their insomnia severity assessed again at post-intervention (9 weeks) and 6 months 
post-treatment. Patients in both groups will also wear the Actiwatch to objectively assess sleep for 2 
weeks before randomization and again for the 2 weeks preceding the post-intervention assessment.   
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
This is a single-site, parallel-group, 2-arm superiority randomized controlled trial of digital CBT-I (Somryst 
+ usual care + sleep hygiene brochure) vs. minimally enhanced usual care (mEUC). Patients randomized 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
to the minimally EUC condition will continue to receive the typical standard of care in that clinic from their 
primary care provider (which may include pharmacotherapy). We have labeled the condition “minimally 
enhanced” because participants will be provided with a sleep hygiene brochure. Minimally EUC was 
chosen as the comparator because it is of high clinical relevance, will allow us to determine if the adapted 
digital CBT-I is superior to usual care, and addresses ethical issues (i.e., identifying but not treating 
insomnia).78 
4.3 
JUSTIFICATION FOR INTERVENTION 
The digital CBT-I program used in this intervention (Somryst) is based off SHUTi , an interactive and 
tailored English-language web-based program modeled on the primary tenets of face-to-face CBT-I shown 
to be effective at reducing insomnia symptoms.26 Participants will be asked to complete six cores (main 
intervention content) during the 9-week intervention period (a new Core becomes available 7 days after 
completion of the previous one). After completing a Core, they can review that Core at any time, and 
access program worksheets from the My Stuff section of the mobile program. The six cores are based on 
the primary treatment components provided in face-to-face cognitive behavioral therapy for insomnia.6,14 
In order to expand access to the gold standard behavioral treatment for insomnia, adaptations of CBT-I to 
other languages and cultural contexts is necessary.  The digital CBT-I (Somryst) has been adapted using a 
rigorous cultural adaptation framework. We used Barrera et al.’s cultural adaptation framework79 to 
conduct formative qualitative research (N=18) and one-on-one personal interviews (N=13) with Spanish-
speaking Latinx adults from the NYC region with chronic insomnia about digital cognitive behavioral 
therapy for insomnia for funded hybrid Type 1 effectiveness-implementation R01  trial (HS024274). As 
part of this process, participant input and feedback about sleep hygiene guidelines and ways in which 
these guidelines could be adapted for their urban context was obtained. Participants identified the need 
for key deep-level content changes to traditional sleep hygiene education, including adaptations for 
socioeconomic status and urban settings such as living in multi-generational households, living in 
apartments and small spaces that required creating separate zones within one room, potential inability 
to regulate room temperatures, and limited control of noise or light pollution,  as well as adaptations to 
sleep hygiene guidelines for safety concerns. Other important adaptations that were made were related 
to the salience of immigrant identity, country of origin/heritage group, the importance of family, and 
adaptations for health literacy and numeracy.  
4.4 
END-OF-STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment, at least 4 intervention sessions, and the 6-month follow-up assessments.  
The end of the study is defined as completion of the 6-month follow-up assessment shown in the Schedule 
of Activities (SoA), Section 1.3. 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
5 
STUDY POPULATION 
5.1 
INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1.
Provision of signed and dated informed screening consent form
2.
Stated willingness to comply with all study procedures and lifestyle considerations (see Section
5.3, Lifestyle Considerations) and availability for the duration of the study (8 months)
3.
Males and females; Age 18-65
4.
Adults with moderate insomnia symptoms as documented on initial eligibility screen based on
validated cut-off for community samples (Insomnia Severity Index Score >10)
5.
Willingness to adhere to the digital therapeutic treatment (study-app based intervention) or
enhanced usual care study regimen
6.
Be Spanish-speaking or bilingual (English and Spanish) adults
7.
Self-identify as Hispanic or Latinx
8.
Report experience of sleep disturbances for at least 3x/week
9.
Report experience of sleep disturbances for at least 3 months
5.2 
EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1.
Participants who are pregnant
2.
Participants who are caregivers (e.g., mothers or fathers) of infants (< 3 months of age) or of adults
who require care at night
3.
Participants who are deemed unable to complete the study protocol as a result of cognitive
impairment, severe medical (i.e., unstable epilepsy or seizure disorder, treatment for cancer or
congestive heart failure, or a condition that may require hospitalizations, surgery, or new
treatments during the study period) or severe mental illness (schizophrenia, psychosis, bipolar I
disorder), or active substance use disorder
4.
Participation in another treatment or intervention study that would interfere with the current
study within the time period beginning from initial baseline assessment until the 6-month follow-
up assessment
5.
Participation in regular night shift work more than 1x/ week
6.
Patients with severe excessive daytime sleepiness ESS>=16
7.
Patients with self-reported previous diagnosis of untreated moderate-to-severe obstructive
sleep apnea
8.
Patients with self-reported or health professional diagnosis of narcolepsy
9.
Patients who have received specialty behavioral treatment for insomnia within the past 3 months
10. Change in prescribed depression medications within the past 3 months
11. Change in prescribed insomnia medications (e.g., hypnotics) within the past 1 month, or use of a
sedative hypnotic beyond the max therapeutic dose

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
12. Unavailable for follow-up during the study period (e.g., plan to leave the country for an
extended period of time without access to internet)
13. Absence of primary care provider consent for patient participation
14. Patients with non-standard sleep patterns (bedtimes outside of 8pm-2am or awakenings outside
of 4am-10am)
15. Patients who have full-time transportation and moving occupations (e.g., full-time motor vehicle
operators, drivers [e.g., Ubers, Lyfts, taxis, trucks], pilots)
Children under 18 years will not be included in the study. They will not be included as chronic insomnia 
is much less common in children than in adults.  
5.3 
LIFESTYLE CONSIDERATIONS 
During this study, participants are asked to: 
•
Refrain from starting specialty behavioral treatment or pharmacotherapy for insomnia.
•
Should not be planning on becoming pregnant in the 8-month duration of the study.
•
Remain available during the study period, and as such should refrain from leaving the country
for an extended period of time
If a participant has used prohibited medications, if they become pregnant during the study duration, or 
leave the country for extended periods of time, that will result in early study intervention discontinuation 
by the study investigator.  
5.4 
SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Individuals who do not meet the 
criteria for participation in this trial (screen failure) because of meeting one or more exclusion criteria that 
are likely to change over time may be rescreened. Examples include participation in night shift work, 
pregnancy, change in psychotropic medications for depression in past 3 months or insomnia in past 1 
month, caregiving for infant <3 months of age or unavailability during the study period. Rescreened 
participants will be assigned the same participant number as for the initial screening. 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
We will enroll 200 Hispanic/Latinx women and men in equal proportion (50% women, 50% men). 
Participants will be from several racial groups (27% American Indian, 15% Black or African American, and 
58% other races or multiple). Participants will be ages 18-65 years old. Participants will be recruited 
through flyers, email, telephone, and primary care provider referrals from the primary care clinics 
affiliated with Columbia University Irving Medical Center and New York Presbyterian Hospital (the 
Ambulatory Care Network) that serves underserved communities across New York City by providing high 
quality and affordable patient-centered care. Recruitment will be conducted remotely or in person 
ensuring safety measures are in line with COVID-19 safety guidelines provided by Centers for Disease 
Control and Prevention and Columbia School of Social Work. All interested patients will complete a 
standard insomnia questionnaire (the Insomnia Severity Index) to determine study eligibility according 
to severity of insomnia, and only those patients with a positive insomnia screen who are eligible to 
participate will be invited for a remote study visit, or an in-person visit dependent on participant 
preference.  
For Spanish-speaking patients: We also have developed a range of strategies aimed at racial/ethnic 
minority patient populations from which we recruit and consent. In particular, we are sensitive to the 
cultural diversity of our population and appreciative of language barriers, issues that must be addressed 
for successful recruitment and retention of participants. To accommodate the Hispanic/Latinx 
community in New York City and the surrounding boroughs, the consent and research participant forms 
will be in Spanish and written at a 6th grade reading level to ensure suitability across literacy levels. In 
addition, our hiring practices have been informed by the needs of our population. For our current 
studies, approximately 75% of our research staff is bilingual and we intend to keep our proportion of 
Spanish speaking staff at about the same proportion in this project. Hispanic/Latinx participants will be 
provided with a copy of the consent form and HIPAA form in Spanish. A verbal explanation by a bilingual 
research member will be provided as well. All ensuing questions will be answered, and participants will 
then be allowed to sign the consent form and HIPAA form.  
Participant incentives 
There are no direct benefits to completing the screener. All adult participants have the opportunity to 
receive up to $180 for their participation depending on which study group they are assigned to. 
Participants will be informed that they are able to stop participation at any time. The participant 
incentives are consistent with going rate for study participation in NYC and are not viewed as coercive.   
A. Somryst Treatment Group (up to $180 total): 
1.
$20 in cash/giftcard for completing the baseline visit
2.
$20 giftcard for wearing the Actiwatch and completing sleep diaries for 14 days at the
group assignment visit.
3.
$20 for wearing the Actiwatch and completing sleep diaries for 14 days after treatment
is complete.
4.
$40 giftcard for a the post-intervention (9 weeks) telephone call.

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
5.
$80 giftcard for a 6-month telephone call.
B. Minimally enhanced usual care (up to $180 total): 
1.
$20 in cash/giftcard for completing the baseline visit
2.
$20 giftcard for wearing the Actiwatch and completing sleep diaries for 14 days at the
group assignment visit.
3.
$20 giftcard for wearing the Actiwatch and completing sleep diaries for 14 days after
treatment is complete.
4.
$40 giftcard for a post-intervention (9 weeks) telephone call.
5.
$80 giftcard for a 6-month telephone call.
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
Intervention Arm: digital CBT-I (Somryst), usual care, and sleep hygiene brochure.  
Patients who are randomized to Somryst will receive the Spanish-language version of the culturally 
adapted Somryst, a self-guided digital program of CBT-I, the usual care provided by their PCP, and a sleep 
hygiene brochure. Somryst, is an interactive and tailored mobile-based program modeled on the primary 
tenets of face-to-face CBT-I, the web version has been shown to be effective at reducing insomnia 
symptoms.25,26  
Patients will be asked to complete six cores (main intervention content) during the 9-week intervention 
period (a new Core becomes available 7 days after completion of the previous one). After completing a 
Core, they can review that Core at any time, and access program worksheets from the My Stuff section of 
the mobile program (App). 
The six cores are based on the primary treatment components provided in face-to-face cognitive 
behavioral therapy for insomnia.6,14 The Behavioral Cores incorporate sleep restriction and stimulus 
control, providing patients with a variety of “rules” to follow in order to retrain their bodies to associate 
sleep with bed. Stimulus control aims to reduce the anxiety or conditioned arousal individuals may feel 
when attempting to go to bed. Sleep restriction is a form of systematic mild sleep deprivation in which a 
sleep window is maintained to allow the body to relearn proper sleeping dynamics and increase sleep 
efficiency. The Educational Core (also called Sleep Hygiene) focuses on general education about sleep 
(e.g., understanding the different types of sleep problems) and improving sleep hygiene and other 
maladaptive behaviors (e.g., establishing regular sleeping schedules, eliminating napping, and avoiding 
nicotine, caffeine, exercise, and drinking alcohol before bedtime). The Cognitive Core (also called 
Cognitive Restructuring) attempts to address and change the negative beliefs and thoughts about sleep 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
that may exacerbate sleep difficulties. In addition to these main Cores, there are two other Cores: the 
Overview and Consolidation/Relapse Prevention Cores. These are critical for each user to receive in order 
to introduce intervention content and provide a rationale for the intervention (Overview); and integrate 
the educational, behavioral, and cognitive elements, promote adherence, generalize the information, 
help the user identify risk situations, and incorporate strategies to reduce relapse (Relapse Prevention). 
Somryst relies on user-entered online Sleep Diaries to track progress and to tailor treatment 
recommendations (i.e., assign a “sleep restriction” window). Intervention content is enhanced through a 
variety of interactive features, including personalized goal-setting, graphical feedback based on inputted 
symptoms, animations/illustrations to enhance comprehension, quizzes to test user knowledge, patient 
vignettes, and video-based expert explanation.  
The primary outcome, insomnia symptoms, will be assessed using the ISI at baseline, at post-intervention 
(9 weeks), and at a 6-month follow-up. Health-related quality of life, sleep quality,  secondary outcomes, 
will also be assessed at the same endpoints as ISI. Daytime sleepiness, another secondary outcome will 
also be assessed at baseline and at the post-intervention (9 weeks), and 6-month follow-up visit. 
Satisfaction with care and sleep quality will be assessed at baseline and at post-intervention (9 weeks) 
and 6-months, and sleep duration and efficiency will be assessed 14 days prior to randomization and at 
post-intervention (9 -weeks). 
Comparator Arm: minimally Enhanced Usual Care (mEUC)- (usual care + sleep hygiene brochure) 
Patients randomized to the mEUC condition will continue to receive the typical standard of care in that 
clinic from their primary care provider (which may include pharmacotherapy). We have labeled the 
condition “minimally enhanced” because patients will be provided with a sleep hygiene brochure. 
Minimally EUC was chosen as the comparator because it is of high clinical relevance, will allow us to 
determine if the adapted digital CBT-I is superior to usual care, and addresses ethical issues (i.e., 
identifying but not treating insomnia).78 Patients randomized to mEUC will complete assessments on the 
same schedule as those randomized to the intervention arm. 
6.1.2 ADMINISTRATION AND/OR DOSING 
Somryst is self-guided as it is a mobile or digital program. Intervention content is metered out over time 
through 6 “Cores:” psychoeducation, sleep restriction, stimulus control, cognitive restructuring, sleep 
hygiene, and relapse prevention. Users obtain access to a new Core 7 days after completion of previous 
Core. Participants will complete the program in 6-9 weeks. A Core is expected to take 45 – 60 minutes to 
review online. Reviewing and implementing program recommendations will take most participants 30 – 
45 minutes per week. Thus, in total, participants in the Somryst group should expect a time commitment 
of up to 12 hours, total. Somryst relies on user-entered online daily Sleep Diaries to track progress and to 
tailor treatment recommendations (i.e., assign a “sleep restriction” window). A complete dose is 
considered completion of 6 cores. We will also collect information about number of sleep diaries 
completed, number of notifications sent, number of days to complete intervention.  
6.2 
FIDELITY 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
Because Somryst is self-guided and delivered completely via mobile App, fidelity to the intervention 
content will be 100% since there are no interventionists. Study personnel will train participants on the use 
of Somryst via a virtual Zoom meeting at the randomization visit.  A checklist for the training session will 
be developed for study personnel which will include a standard set of app functions to review such as how 
to sign on and off of the app, how to navigate the app, and where to find help information on the app. 
Study videos related to downloading the app and completing sleep diaries will be available to participants 
and posted on the study website.  
Protocol compliance will be reviewed during weekly meetings between Dr. Alcantara, TBN (Project 
Coordinator) and the research assistants, as well as at monthly meetings (more frequent if required) 
between Dr. Alcantara and the other co-Is (Drs. Kronish, Schwartz, Moise). Finally, the Project 
Coordinator will perform a random audit of 5% of study visits, and provide continual feedback to 
improve the quality of informed consent and data collection. 
We have a number of strategies to ensure the quality of the data. First, the web-based electronic data 
entry system we will use “forces” responses to most questionnaire items before allowing progression 
through the particular interview’s template, thereby avoiding problems with missing data. For some 
items, delayed data entry is possible. Further, each time the research coordinator logs into the secure 
data entry system, it prompts pop up on the initial screen showing what data elements remain 
incomplete, to encourage complete data capture. After enrollment of the first 5 participants, the 
Steering Committee, led by PI Dr. Alcantara will examine the data to ensure adequacy and accuracy of 
data collection. Finally, as mentioned above, the DSMB will also review data completeness, accuracy, 
and timeliness. 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
Randomization. After completing the baseline assessment, patients will be randomly assigned in a 1:1 
ratio to either the Culturally Adapted Somryst or minimally Enhanced Usual Care (mEUC) condition. 
Randomization will be generated by a computerized random-number sequence programmed by the 
study statistician and implemented in the  secure, password-protected, encrypted data tracking 
program. The sequence will be unknown to research assistants enrolling patients.  
Blinding. One research staff member (TBN)  will be responsible for randomizing participants and so this 
research assistant and the PI will be unblinded to study condition. Participants will also be unblinded to 
study condition since treatment conditions will be obvious to them. Research assistants conducting the 
post-intervention (9 weeks) and 6-month outcome assessments will be blinded to participants’ 
treatment condition, as this is preferred to minimize risk of bias in outcome ascertainment.  
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
Participants will be asked to complete daily sleep diaries and weekly Cores (6 total) over a 9-week (63 
days) period. Research staff will receive weekly information about participant engagement with the digital 
treatment, including number of log-ins, number of minutes to complete core, number of sleep diaries 
completed, and time elapsed since completion of core. In the event that participants have not started the 
App, a notification reminder is sent every day for 8 days. Also, periodic notifications are sent after a set 
period of non-activity. Please see Appendix of Administrative forms for example notification log.   
6.5 
CONCOMITANT THERAPY 
For this protocol, participants may not begin any specialized behavioral treatment or pharmacotherapy 
for insomnia for the duration of the study.  
6.5.1 RESCUE THERAPY 
N/A 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
When a participant discontinues from Somryst but not from the study, remaining study procedures will 
be completed as indicated by the study protocol.  If a clinically significant finding is identified (including, 
but not limited to changes from baseline) after enrollment, the investigator or qualified designee will 
determine if any change in participant management is needed. Any new clinically relevant finding will be 
reported as an adverse event (AE). 
The data to be collected at the time of study intervention discontinuation will include the following: 
•
The reason(s) for discontinuing the participant from the intervention, and methods for
determining the need to discontinue 
•
If the participant is due to complete assessments within 2 weeks of being discontinued from the
study intervention, those assessments will be administered at the time of discontinuation; if the next 
scheduled assessments are more than 2 weeks from the discontinuation date, the discontinued 
participant will wait for the next scheduled assessment. Thereafter, the participant will be included in all 
future scheduled assessments, even though not participating in the intervention. 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
•
Any event or medical condition or situation occurs such that continued collection of follow-up
study data would not be in the best interest of the participant or might require an additional
treatment that would confound the interpretation of the study
•
The participant meets an exclusion criterion (either newly developed or not previously
recognized) that precludes further study participation
The reason for participant discontinuation from the study will be recorded on the  Case Report Form (CRF) 
accessed through the data management platform. Participants who sign the informed consent form and 
are randomized but do not receive the study intervention may be replaced.  Participants who sign the 
informed consent form, and are randomized and receive the study intervention, and subsequently 
withdraw, or are discontinued from the study, will not be replaced. 
7.3 
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if he or she fails to return for 3 scheduled visits and study 
staff are unable to contact the participant after at least 3 attempts.  
The following actions must be taken if a participant fails to return to the clinic/virtual meeting for a 
required study visit: 
•
The site will attempt to contact the participant, reschedule the missed visit within 14 days, counsel
the participant on the importance of maintaining the assigned visit schedule and ascertain if the
participant wishes to and/or should continue in the study
•
Before a participant is deemed lost to follow-up, the investigator or designee will make every
effort to regain contact with the participant (where possible, 3 telephone calls and texts, if
necessary, a certified letter to the participant’s last known mailing address, email, or local
equivalent methods). These contact attempts will be documented in the participant’s study file.
8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Overview: 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
Study candidates who meet initial eligibility criteria and consent to participate will be invited for an 
office visit or a virtual visit where they will complete a baseline sociodemographic and psychosocial 
survey battery, and be asked to complete a daily sleep diary for 14 days and to wear an actigraph 
(Actiwatch) to capture continuous objective sleep data on sleep duration and sleep efficiency for 14 
days. Participants will be asked to return their actiwatch via mail. After completing the baseline 
assessment, patients will be randomly assigned in a 1:1 ratio to either the Culturally Adapted Somryst 
intervention condition or to minimally Enhanced Usual Care (mEUC) condition. Patients in the 
intervention group receive digital CBT-I, usual care, and a sleep hygiene brochure. Patients will also be 
trained on how to record their daily sleep diaries using a smartphone diary; and will receive prompts on 
their smartphones or emails to remind them when to complete the daily sleep diaries. Patients 
randomized to the control group will receive minimally enhanced usual care, which will include usual 
care provided by their PCP and a sleep hygiene brochure. Patients in both groups will have their 
insomnia severity assessed again at a post-intervention (9 weeks) and 6-months. Patients in both groups 
will also wear the ActiwatchSpectrum Pro to objectively assess sleep for 2 weeks after enrollment and 
again for 2 weeks post-intervention (9 weeks). 
All study surveys will be administered by research staff remotely via a teleconference platform or in-
person dependent on participant preference. 
Screening & Primary Endpoint: 
All interested patients will complete a standard screening questionnaire to determine study eligibility 
according to severity of insomnia. Basic sociodemographic and technological literacy information will be 
collected. Insomnia symptoms in the past 2 weeks will be measured with the Insomnia-Severity Index 
(ISI) in order to assess severity of insomnia.80  The ISI has excellent psychometric properties, and is 
reliable and valid in English,80 and adapted for use in Spanish-speaking populations.81 Changes in 
insomnia symptoms will also serve as the primary outcome. 
Baseline:  
Study candidates who meet initial eligibility criteria and consent to participate will be invited to a virtual 
online visit where they will complete a baseline sociodemographic and psychosocial survey battery.  
Secondary Outcomes: 
Health-related quality of life will be assessed through the validated Short-Form 12 (SF-12), which is a 12-
item self-report inventory that generically measures quality of life; it yields a measure of global health-
related wellbeing as 8 domain-specific subscores.82 This will be assessed at baseline and at post-
intervention (9 weeks) and 6-month follow-up.  
Sleepiness will be measured with the 8-item Epworth Sleepiness Scale, a brief, validated self-report scale 
of daytime sleepiness with excellent psychometric properties.83 This will be assessed at baseline and at 
post-intervention (9 weeks) and 6-month follow-up. 
Satisfaction with care will be measured using a question adapted for this trial asking patients to rate the 
quality of professional care they have received for their symptoms of insomnia.84 This will be assessed at 
baseline and at the post-intervention visit (9 weeks). Based on current best practices66 of cultural 
adaptation of evidence-based interventions, we will also ask participants in the intervention group to 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
rate their satisfaction with, as well as their difficulties with program content or activities after each 
online session.  
Self-reported and actigraphy assessed wake after sleep onset and self-reported sleep onset latency will 
be assessed at baseline and at post-intervention for 14 days.  
Sleep duration and sleep efficiency will be measured continuously and unobtrusively for 14 days 
following the baseline visit and post-intervention using the ActiWatch SpectrumPRO, a waterproof, 
lightweight, actigraphy-based device that measures physical activity continuously and can be worn for 
24 hours daily. The validity of actigraphy for determining sleep duration in particular, compared with the 
gold standard polysomnography, is excellent.85  
Sleep quality will be measured at baseline, post-intervention, and at 6-months follow-up with The 
Pittsburgh Sleep Quality Index (PSQI),86 which has excellent psychometric properties, and established 
validity among Spanish-speakers.87  
Other Measures: Sociodemographic Information will be collected at screening including, age, sex, 
race, country of origin, educational attainment, nativity status, household income, employment status, 
and health insurance status. Direct health care costs will consist of the retail costs of Somryst (payer’s 
costs plus patient out-of-pocket costs). Structured interviews will gather information about health care 
utilization (primary care, other ambulatory care, emergency department, or hospital visits). Indirect 
costs will include patients’ lost productivity due to 1) participating in Somryst sessions, and 2) lost 
productivity related to poor sleep quality.  
8.2 
SAFETY ASSESSMENTS 
Safety assessments will include inquiries into experience of adverse events through semi-structured 
interviews during the post-intervention (9 weeks) and 6-month assessments. There will also be a creation 
of a Data Safety and Monitoring Board that will monitor and review adverse events and safety.  
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered intervention-
related. 
An adverse event will be defined as any undesirable symptom, accident, or medical condition 
considered related or possibly related to the intervention. Medical conditions present before the 
intervention will be considered adverse events only if they worsen after starting the study and that 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
worsening is considered to be related to the study intervention. An adverse event is also any 
undesirable and unintended effect of research occurring in human subjects as a result of the collection 
of identifiable private information under the research. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
Serious adverse event: The adverse event will be deemed serious if it is determined to be associated or 
possibly associated with study involvement, and results in any of the following outcomes: death, a life-
threatening adverse experience, in-subject hospitalization or prolongation of existing hospitalization, a 
persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical 
events that may not result in death, be life-threatening, or require hospitalization may be considered a 
serious adverse experience when, based upon appropriate medical judgment, they may jeopardize the 
subject and may require medical or surgical intervention to prevent one of the outcomes listed above.  
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.  
•
No adverse event or within normal limits
•
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily
activities.
•
Moderate – Events result in a low level of inconvenience or concern with the therapeutic
measures. Moderate events may cause some interference with functioning.
•
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug
therapy or other treatment. Severe events are usually potentially life-threatening or
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.
•
Life-threatening or disabling adverse event
•
Fatal adverse event
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately-trained clinician (PI and study physician Co-I) based on temporal relationship 
and his/her clinical judgment. The degree of certainty about causality will be graded using the categories 
below.  

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
•
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test
result, occurs in a plausible time relationship to study procedures administration and cannot be
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the
study procedures should be clinically plausible. The event must be pharmacologically or
phenomenologically definitive.
•
Probably Related – There is evidence to suggest a causal relationship, and the influence of other
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a
reasonable time after administration of the study procedures, is unlikely to be attributed to
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on
withdrawal.
•
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event
occurred within a reasonable time after administration of study procedures). However, other
factors may have contributed to the event (e.g., the participant’s clinical condition, other
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it
can be flagged as requiring more information and later be upgraded to “probably related” or
“definitely related”, as appropriate.
•
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose
temporal relationship to study procedures administration makes a causal relationship improbable
(e.g., the event did not occur within a reasonable time after administration of the study
procedures) and in which other drugs or chemicals or underlying disease provides plausible
explanations (e.g., the participant’s clinical condition, other concomitant treatments).
•
Not Related – The AE is completely independent of study procedures administration, and/or
evidence exists that the event is definitely related to another etiology. There must be an
alternative, definitive etiology documented by the clinician.]
8.3.3.3 EXPECTEDNESS 
A clinician (general internist) with appropriate expertise in insomnia will be responsible for determining 
whether an adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the 
nature, severity, or frequency of the event is not consistent with the risk information previously described 
for the study procedures. 
Anticipated or expected adverse events will include: initial discomfort/embarrassment from discussion 
of topics of a sensitive nature or wearing the actigraph, initial tiredness/fatigue from the sleep 
restriction component of the intervention, and participant confidentiality and privacy concerns about 
sharing personal information on a digital platform.  
Potentially intervention related serious adverse events will include fatigue-related accidents (motor 
vehicle accidents, work-related accidents). 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care, or 
upon review by a study monitor. 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form 
(CRF). Information to be collected includes event description, time of onset, clinician’s assessment of 
severity, relationship to study procedures (assessed only by those with the training and authority to make 
a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
Research Staff will record events with start dates occurring any time after informed consent is obtained 
until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.  At each study 
visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit.  Events will be 
followed for outcome information until resolution or stabilization. 
8.3.5 ADVERSE EVENT REPORTING 
Any adverse event (AE) or unanticipated problem will be identified, responded to, recorded by the PI. If 
the AE or problem is unexpected, related to study involvement, and puts the participant at increased 
risk, it will be reported to the Columbia IRB immediately, in accordance with local policies, in addition to 
the Data Safety and Monitoring Board (DSMB) and if necessary, AHRQ. All other AEs and problems will 
be reported at the time of continuing renewal. 
8.3.6 SERIOUS ADVERSE EVENT REPORTING 
In consultation with the PI, a trained member of the study team (study physicians, Moise, Kronish) will be 
responsible for conducting an evaluation of a serious adverse event and shall report the results of such 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
evaluation to the NIH and the reviewing Institutional Review Board (IRB) as soon as possible, but in no 
event later than 10 working days after the investigator first learns of the event 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
The PI and study team will follow DSMB guidance regarding reporting of adverse events to participants. 
8.3.8 EVENTS OF SPECIAL INTEREST 
N/A 
8.3.9 REPORTING OF PREGNANCY  
Pregnancy is not reported as an adverse event. In the event of a pregnancy during trial participant, 
participants will be asked to discontinue the study intervention.  
8.4 
UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, 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 Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the
participant population being studied;
•
Related or possibly related to participation in the research (“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); and
•
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.
8.4.2  UNANTICIPATED PROBLEMS REPORTING 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the Data Safety and Monitoring Board/AHRQ. The UP report will include the following 
information: 
•
Protocol identifying information: protocol title and number, PI’s name, and the IRB project
number
•
A detailed description of the event, incident, experience, or outcome
•
An explanation of the basis for determining that the event, incident, experience, or outcome
represents an UP
•
A description of any changes to the protocol or other corrective actions that have been taken or
are proposed in response to the UP
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
•
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the Data Safety and
Monitoring Board/AHRQ immediately within 24 hours of the investigator becoming aware of the
event
•
Any other UP will be reported to the IRB and to the DCC/study sponsor/funding agency within 14
days of the investigator becoming aware of the problem
•
All UPs should be reported to appropriate institutional officials (as required by an institution’s
written reporting procedures), the supporting agency head (or designee), and the Office for
Human Research Protections (OHRP) within 30 days of the IRB’s receipt of the report of the
problem from the investigator
These 
policies 
are 
informed 
by 
https://www.nhlbi.nih.gov/grants-and-training/policies-and-
guidelines/nhlbi-adverse-event-and-unanticipated-problem-reporting-policy.  
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
The PI and study team will follow DSMB guidance regarding reporting of unanticipated problems to 
participants.  
9 
STATISTICAL CONSIDERATIONS 
We will post or pre-register our planned analysis plan in clinicaltrials.gov. Information will be provided on 
the analysis plan for the primary endpoint.   
9.1 
STATISTICAL HYPOTHESES 
[Primary endpoint] Our primary hypothesis is that patients randomized to the Somryst treatment will 
experience a greater improvement (from baseline) in the Insomnia Severity Index (ISI) at post-
intervention (9 weeks)  compared to those randomized to mEUC, and scores will continue to be better 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
than mEUC patients at 6 months post-intervention. The null hypothesis is that there will be no 
difference in the ISI scores between patients randomized to the Somryst treatment versus those 
assigned mEUC. 
[Secondary endpoints] Our secondary hypothesis is that Somryst will result in greater improvement in 
quality of life, as captured by the more general SF-12 that will be assessed pre- and post-intervention in 
both the Somryst and mEUC participants. We will use the validated method of Brazier et al. to calculate 
utilities (QALY penalties) from baseline and post-intervention (9 weeks) SF-12 data by first mapping 
responses to the simpler SF-6D scale and then using a regression model to estimate single index 
scores.92, 108 Additionally patients in the Somryst treatment will exhibit greater improvement in scores 
for self-reported daytime sleepiness, satisfaction with care, actigraphy-assessed sleep duration and 
actigraphy-assessed sleep efficiency, and self-reported sleep quality compared to mEUC patients. 
9.2 
SAMPLE SIZE DETERMINATION 
Prior studies suggest that CBT-I yields approximately an 8-point reduction in the ISI, our primary 
measure of insomnia, with the standard deviation (SD) of post-intervention change scores being 4 to 5 
points. Our expectation is that the improvement in patients assigned to the intervention condition 
(Somryst) will be 8 points or greater, and that those assigned to minimally enhanced usual care (mEUC) 
will exhibit a 5-point improvement. Typically, we expect the SD of change scores to increase for longer 
intervals (e.g., 6 or 12 months), and have therefore conservatively based our power calculations on a SD 
(change) of 6.0. Accordingly, randomization of 200 patients to Somryst versus mEUC (1-to-1 ratio) will 
provide 90% power to detect a differential reduction (post-intervention and 6-month follow-up) in ISI of 
3 points or larger, using a 2-tailed Wald chi-square test of the appropriate contrast. This sample size 
estimate allows for up to 15% attrition, such that we have baseline data on all 200 patients (collected 
prior to randomization), but follow-up data on only 170.  
9.3 
POPULATIONS FOR ANALYSES 
All primary analyses will be conducted according to the intent-to-treat principle, with all randomized 
patients included in the analysis and their group classification (Somryst versus  minimally EUC) based on 
the condition to which they were randomly assigned. 
9.4 
STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
The distributions of all clinical measures will be reviewed for outliers. Those exhibiting substantial 
skewness will be transformed (e.g., log or square root) to make their distribution more appropriate for 
parametric procedures. Independent-sample t-tests and chi-square analyses will be used to examine 
baseline differences between the two treatment groups (Somryst vs. mEUC) in clinical and 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
sociodemographic characteristics. All primary analyses will be conducted according to the intent-to-treat 
principle, with all randomized patients included in the analysis and their group classification (Somryst 
versus mEUC) based on the condition to which they were randomly assigned. 
. 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
Mixed-model RM-ANOVA will be used to estimate and compare the changes in the primary endpoint 
(ISI) and other patient-important outcomes (e.g., insomnia symptom severity, daytime sleepiness) 
between Somryst and mEUC. The RM-ANOVA model will include Group (Somryst versus mEUC), Time 
(baseline, post-intervention and 6-month follow-up), and the Group × Time interaction as fixed factors 
with an unstructured residuals covariance matrix. This will yield estimates of the within-group means 
and standard errors at each assessment. Specific interaction contrasts (e.g., Group × Pre-vs-Post 
Intervention) will be estimated to estimate the magnitude and test the statistical significance of the 
differential change in insomnia symptoms using the Wald χ2 statistic. We will plot the mean insomnia 
scores across assessments, stratified by treatment group, to elucidate the nature of the interaction (i.e., 
whether Somryst resulted in significantly greater improvements [or lesser worsening] than mEUC). If, 
despite randomization, the two groups differ substantially (p<0.10 after stepdown Bonferroni 
correction) on one or more sociodemographic or clinical factors assessed at baseline, sensitivity analyses 
will be performed in which these factors are included as covariates in the RM-ANOVA, in order to rule 
out the possibility that the results from the primary analyses are attributable to group differences on 
these factors. The same analyses will be repeated to estimate and compare changes in the primary 
endpoint and secondary endpoints between Somryst and mEUC at 6-months.  
Significance will be evaluated with a two-tailed p value of 0.05. To control for multiplicity, post-
intervention will be evaluated first and if significant timepoints post-intervention and 6-months follow-
up will be evaluated.  In addition, estimated marginal means ± 95% confidence intervals will be 
calculated for each assessment point and Cohen’s d will be used as an estimate of effect size for the 
change from baseline to each assessment point.  
Missing Data: We will use multilevel mixed models to perform intent-to-treat RM-ANOVA. There will be 
no missing data at baseline, because we will only randomize patients who have successfully completed 
the baseline assessment, and therefore all 200 patients will be included in the analyses. The software used 
to estimate the mixed models yields full-information maximum-likelihood parameter estimates that are 
robust with respect to data that are “missing at random”. This will appropriately handle the possibility 
that attrition (or missing data) is related to either baseline level of the outcome measure, group 
assignment, or their interaction. However, if we discover that attrition is associated with some other 
characteristic (e.g., sex or age), we will use multiple imputation (chained equation approach104, 105) and 
include the associated characteristic in the imputation model.106 We will do everything possible to collect 
data on the reasons for dropout, who decided the participant should drop out (e.g., their PCP), and 
whether the dropout involves any aspect of participation in the study. Even if the patient drops out of the 
intervention, we will still seek to collect their key outcome information. We will compare key 
characteristics of participants with and without missing data. In cases where there are large differences 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
in missing data, we will cautiously interpret our findings and will consider limitations in generalizability 
that might have been introduced by these differences. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
For secondary endpoints, , we will follow Hochberg’s step-up approach as outlined in Figure 2. 
Coupled  with our primary hypothesis that CBT-I will result in improved ISI scores, a secondary hypothesis 
is that CBT-I will result in greater improvement in quality of life, as captured by the more general SF-12 
that will be measured pre- and post-intervention in both the CBT-I and mEUC participants. We will use 
the validated method of Brazier et al. to calculate utilities (QALY penalties) from baseline and post-
intervention SF-12  data by first mapping responses to the simpler SF-6D scale and then using a regression 
model to estimate single index scores.97, 98 The cost-effectiveness analysis will compare incremental 
costs  and quality-adjusted life years (QALYs) gained in the CBT-I arm compared with mEUC. The primary 
cost-effectiveness analysis will be from the payer’s point of view (government, insurer, or health 
Figure 2.  Decision structure for hypothesis testing of primary and secondary endpoints
H1a: patients randomized to the 
Somryst treatment will experience 
greater improvement (from 
baseline) in the Insomnia Severity 
Index (ISI) at post-intervention (9 
weeks) compared to those 
randomized to mEUC (α=0.05)
Supported
No further 
hypothesis testing
Secondary endpoints tested using 
Hochberg’s step-up approach (α=0.05)
H1b: patients randomized to the 
Somryst treatment will experience 
greater improvement (from 
baseline) in the Insomnia Severity 
Index (ISI) at 6 months post-
intervention compared to those 
randomized to mEUC (α=0.025)
Not supported
Supported
Not supported
Secondary endpoints tested using 
Hochberg’s step-up approach (α=0.025)

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
organization). The secondary cost-effectiveness analysis will be from the patient’s point of view and 
include out-of-pocket medical costs and costs of lost productivity (both due to participation in Somryst 
sessions and due to poor sleep quality).  For the main analysis from the payer’s point of view, we will 
include cumulative CBT-I costs for the intervention arm payers and patients’ combined costs to access and 
complete the web-based CBT-I intervention), and  for both CBT-I and mEUC we will gather cumulative 
utilization data on medications, office visits, emergency department visits, and hospitalizations over the 
follow up period. We anticipate that most of these data can be gathered from EPIC the electronic health 
record (EHR) used in the AIM Clinic and New York Presbyterian Hospital, but participant follow up 
interviews will both validate electronic record data and capture any health care utilization at outside 
clinics and hospitals. Health facility visit costs will be entered as the reimbursement for that visit type 
specified by the Centers for Medicare and Medicaid Services99 fee schedule. Mean wholesale medication 
prices will be estimated from the most recent “Redbook” listing of wholesale drug costs. For the secondary 
analysis from the patient’s point of view, we will analyze data from participant interviews data on out-of-
pocket medication costs, office visit co-pays, and lost compensation and missed work. Productivity losses 
will be estimated by multiplying age-specific labor force participation rates by average age-specific U.S. 
adult annual earnings for the participant’s time observed in in the trial. Sources for average annual 
earnings (Current Population Survey 2014), labor force participation rate (Bureau of Labor Statistics, BLS), 
and consumption costs (BLS Consumer Expenditure Survey) were summarized in the Second Panel of Cost-
Effectiveness. 
Cost-effectiveness will be assessed based on the study observation period (9 weeks)  in the main 
analysis, but micro- simulation analyses will simulate sustaining the insomnia prevention effects of 
CBT-I and EUC for years into the future, up to 10 years. Incremental cost-effectiveness ratios (ICERs) 
will be calculated as incremental change in costs divided by incremental change in QALYs comparing 
Somryst  to mEUC).). ICERs will be assessed as follows (in 2021 $U.S.): <$50,000 per QALY gained will 
be considered cost-effective, ≥$50,000 and <$150,000 of intermediate value, and ≥$150,000 of low 
value. Non-parametric bootstrapping with 1,000 random samples of all QALY and cost distributions 
will be used to generate 95% uncertainty intervals for cost- effectiveness ratios.100 Sensitivity 
analyses will test the robustness of the cost-effectiveness estimate to a range of inputs regarding 
intervention costs, productivity and quality of life losses related to chronic insomnia, size of quality of 
life improvement effect, and durability of intervention effect (ranging from one month to ten years). 
Cost-effectiveness analyses will be carried out and reported according to the Consolidated Health 
Economic Evaluation Reporting Standards (CHEERS).101 Cost-effectiveness analyses will be carried 
out in TreeAgesoftware (TreeAge Inc., Williamstown, MA) 
9.4.4 SAFETY ANALYSES 
N/A 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
Independent-sample t-tests and chi-square analyses will be used to examine baseline differences between 
the two treatment groups (Somryst vs. mEUC) in clinical and sociodemographic characteristics.  
9.4.6 PLANNED INTERIM ANALYSES 
N/A.  
9.4.7 SUB-GROUP ANALYSES 
In secondary analyses, we will repeat the primary analyses stratified by age, gender, nativity status, 
number of medical comorbidities, socioeconomic status, employment status, language proficiency, 
psychological profile [depression, anxiety, stress scores.  The results (point estimates and 95% 
confidence intervals) will be displayed in a Forest plot, where marked subgroup differences will be 
visually evident and used for hypothesis generation about whether one or more of these factors 
influences treatment response.  
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Individual participant data will be listed by measure and time point. 
9.4.9 EXPLORATORY ANALYSES 
We will also conduct an exploratory analysis of treatment effect modification by baseline comorbidity 
level, a sensitivity analysis in which those using sleep medications are excluded, and a test of whether 
there were any group differences in the initiation/use of sleep medications (prescribed or over the 
counter)  
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to 
the participant and written documentation of informed consent will be completed prior to starting the 
study intervention. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Patients who are eligible to participate will be invited for a remote or in-person study visit at which we 
will obtain verbal informed consent after explaining the study and ensuring that patients understand all 
study components including the nature of their participation, the meaning of randomization, 
and equipoise between the two arms of the trial. Participants will receive consent form via email or in 
the mail prior to the remote visit. Participants who attend in-person visits will receive a copy of the 
consent form. Before consenting patients for the trial, permission for patients’ participation will be 
obtained from their primary care providers (PCPs). Consent and all research participant forms will be 
translated into Spanish given that this study focuses on the Spanish speaking  Hispanic/Latinx 
community in New York City and the surrounding boroughs. Our research staff is bilingual and will 
facilitate consent in Spanish with Spanish-speaking participants. All staff involved in this study will 
have completed and passed GCP and HIPAA training, and will have been provided with materials and 
instruction in the proper and ethical manner in which consent should be obtained. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to  study participants, investigators, AHRQ, and regulatory 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
authorities. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the Institutional Review Board (IRB), and sponsor/funding agency and 
will provide the reason(s) for the termination or suspension. Study participants will be contacted, as 
applicable, and be informed of changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
•
Determination of unexpected, significant, or unacceptable risk to participants
•
Demonstration of efficacy that would warrant stopping
•
Insufficient compliance of study staff to the protocol   (ie, significant protocol violations)
•
Data that are not sufficiently complete and/or evaluable
•
Determination that the primary endpoint has been met
•
Determination of futility
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, Food and Drug Administration (FDA), or other relevant 
regulatory or oversight bodies (OHRP, DSMB). 
10.1.3 CONFIDENTIALITY AND PRIVACY 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency.  
All research activities will be conducted in as private a setting as possible. 
The study monitor, other authorized representatives of the sponsor or funding agency, representatives of 
the Institutional Review Board (IRB), regulatory agencies or representatives from companies or 
organizations supplying the product, may inspect all documents and records required to be maintained 
by the investigator, including but not limited to, survey records for the participants in this study. The PI 
will permit access to such records. 
The study participant’s contact information will be securely stored on a virtual data management platform 
for internal use during the study. At the end of the study, all records will continue to be kept in this secure 
virtual data management platform for as long a period as dictated by the reviewing IRB, Institutional 
policies, or sponsor/funding agency requirements. 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be stored in an encrypted study laptop. This will not include the participant’s contact or identifying 
information. Rather, individual participants and their research data will be identified by a unique study 
identification number. The study data entry and study management systems used by clinical sites and by 
Columbia University research staff will be secured and password protected. 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies  
It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate.  
Certificate of Confidentiality 
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical 
or other human subjects research funded wholly or in part by the federal government.  Recipients of NIH 
funding for human subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set forth 
in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research covered 
by this Policy are required to establish and maintain effective internal controls (e.g., policies and 
procedures) that provide reasonable assurance that the award is managed in compliance with Federal 
statutes, regulations, and the terms and conditions of award. It is the NIH policy that investigators and 
others who have access to research records will not disclose identifying information except when the 
participant consents or in certain instances when federal, state, or local law or regulation requires 
disclosure. NIH expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy. 

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
11 REFERENCES 
1.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed.
American Psychiatric Publishing; 2013.
2.
Medicine Aa. International Classification of Sleep Disorders, 2nd Ed.: Diagnostic and Coding
Manual. 2nd ed.; 2005.
3.
Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. National Academy of the
Sciences; 2006.
4.
Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep
Medicine Reviews. 2002;6(2):97-111. doi:10.1053/smrv.2002.0186
5.
Crimmins EM, Kim JK, Alley DE, Karlamangla A, Seeman T. Hispanic paradox in biological risk
profiles. American journal of public health. 2007;97(7):1305-1310.
6.
Hohagen F, Rink K, Käppler C, et al. Prevalence and treatment of insomnia in general practice.
European archives of psychiatry and clinical neuroscience. 1993;242(6):329-336.
7.
Simon GE, VonKorff M. Prevalence, burden, and treatment of insomnia in primary care. American
Journal of Psychiatry. 1997;154(10):1417-1423.
8.
Singh GK, Siahpush M. Ethnic-immigrant differentials in health behaviors, morbidity, and cause-
specific mortality in the United States: an analysis of two national data bases. Human biology.
Published online 2002:83-109.
9.
Bild DE, Detrano R, Peterson DO, et al. Ethnic differences in coronary calcification: the Multi-Ethnic
Study of Atherosclerosis (MESA). Circulation. 2005;111(10):1313-1320.
10.
Ford ES, Cunningham TJ, Giles WH, Croft JB. Trends in insomnia and excessive daytime sleepiness
among US adults from 2002 to 2012. Sleep Medicine. 2015;16(3):372-378.
doi:10.1016/j.sleep.2014.12.008
11.
Foundation N. Sleep in America Poll.; 2010.
12.
Foundation N. Sleep in American Poll.; 2002.
13.
Morin CM, Vallières A, Guay B, et al. Cognitive behavioral therapy, singly and combined with
medication, for persistent insomnia: a randomized controlled trial. Jama. 2009;301(19):2005-2015.
14.
Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for
insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health
Psychology. 2006;25(1):3.

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
15.
Parker Frisbie W, Cho Y, Hummer RA. Immigration and the health of Asian and Pacific Islander
adults in the United States. American journal of epidemiology. 2001;153(4):372-380.
16.
Cascade EF, Kalali AH, Reites J. Current status of hypnotic prescribing habits in the United States.
Psychiatry (Edgmont). 2007;4(9):24.
17.
McHugh RK, Whitton SW, Peckham AD, Welge JA, Otto MW. Patient preference for psychological
vs pharmacologic treatment of psychiatric disorders: a meta-analytic review. The Journal of clinical
psychiatry. 2013;74(6):595-602.
18.
Benca RM. Diagnosis and treatment of chronic insomnia: a review. Psychiatric services.
2005;56(3):332-343.
19.
Shah AD, Vittinghoff E, Kandula NR, Srivastava S, Kanaya AM. Correlates of prediabetes and type II
diabetes in US South Asians: findings from the Mediators of Atherosclerosis in South Asians Living
in America (MASALA) study. Annals of epidemiology. 2015;25(2):77-83.
20.
Medina-Inojosa J, Jean N, Cortes-Bergoderi M, Lopez-Jimenez F. The Hispanic paradox in
cardiovascular disease and total mortality. Progress in cardiovascular diseases. 2014;57(3):286-
292. 
21.
Gonzalez HM, Vega WA, Williams DR, Tarraf W, West BT, Neighbors HW. Depression care in the
United States: too little for too few. Archives of general psychiatry. 2010;67(1):37-46.
22.
Nelson AR. Unequal treatment: report of the Institute of Medicine on racial and ethnic disparities
in healthcare. The Annals of thoracic surgery. 2003;76(4):S1377-S1381.
23.
Office of the Surgeon General (US), Center for Mental Health Services (US), National Institute of
Mental Health (US). Mental Health: Culture, Race, and Ethnicity: A Supplement to Mental Health: A
Report of the Surgeon General. Substance Abuse and Mental Health Services Administration (US);
2001. Accessed June 24, 2021. http://www.ncbi.nlm.nih.gov/books/NBK44243/
24.
Manber R, Carney C, Edinger J, et al. Dissemination of CBTI to the non-sleep specialist: protocol
development and training issues. Journal of Clinical Sleep Medicine. 2012;8(2):209-218.
25.
Ritterband LM, Thorndike FP, Gonder-Frederick LA, et al. Efficacy of an Internet-based behavioral
intervention for adults with insomnia. Archives of general psychiatry. 2009;66(7):692-698.
26.
Ritterband LM, Thorndike FP, Ingersoll KS, et al. Effect of a web-based cognitive behavior therapy
for insomnia intervention with 1-year follow-up: a randomized clinical trial. JAMA psychiatry.
2017;74(1):68-75.
27.
Ye Y, Zhang Y, Chen J, et al. Internet-based cognitive behavioral therapy for insomnia (ICBT-i)
improves comorbid anxiety and depression—a meta-analysis of randomized controlled trials. PLoS
One. 2015;10(11):e0142258.

(+&"+#(+-.26'(&"3('-+(%%+"%(.%-.+%%2)-" "-%+-&'-(( '"-"/:
!/"(+%!+)2(+
',(&'"(+)'",!)$"' -"'9(+"&+2+-"'-,
@G2A?AA

	3050!0,#-1,5#&03#(7)03,."0!),!)#.!#4#4#3!(
[aE
#:&&#35B')4#55:B."'3&B#5,E
.5#3.#5J"#,)7#3#"!0'.)5)7# #(7)03,5(#31:5053#5
).40-.)D4:45#-5)!3#7)#8."-#5J.,:4)4E$''&E[YZ_CZZO[PD#YZ]bZ\bE
[bE
3.#"5B6"")(:B8.40.B)!+#55B)+#.4B(#37).E."0-);#"!0.530,,#"53),0&
5#,#1(0.#J"#,)7#3#"!0'.)5)7# #(7)03,5(#31:&03!(30.)!).40-.)E$(E[YZ\C\_O\PD\^\J\_[E
\YE
	0,-27)45B).!#.5B,4(E# J745#,#(#,5(J 4#""#,)7#3:0&!0'.)5)7# #(7)03,
5(#31:&03).40-.)D3."0-);#"!0.530,,#"53),E$(%!!&E[YZ]CZ^O[PDZa`JZb^E
\ZE
41)#B:,#B),,)-4B#5,E3."0-);#"B1,!# 0J!0.530,,#"53),0&0.,).#!0'.)5)7#
 #(7)03,5(#31:&03!(30.)!).40-.)")403"#3"#,)7#3#"7).650-5#"-#")J3)!(8# 
11,)!5)0.E$(E[YZ[C\^O_PD`_bJ`aZE
\[E
45)#.	B03).B6#,,#5JB,)4B06!(3"E0'.)5)7#J #(7)03,5(#31:&03
).40-.)D!0-13)40.0&).")7)"6,5(#31:B'30615(#31:B."5#,#1(0.#!0.46,55)0.4E',)&$
''&*,$+!&&$!&!$(*0 '$'0E[YY]C`[O]PD_^\E
\\E
41)#B!(0.B#,,:	JB#5,E."0-);#"!,).)!,#&&#!5)7#.#4453),0&.634#J
"-).)45#3#"4-,,J'3061!0'.)5)7# #(7)035(#31:&031#34)45#.5).40-.)).'#.#3,13!5)!#E
$(E[YY`C\YO^PD^`]J^a]E
\]E
05(#,)64B:(,#B41)#B30-.JE.6,J'6)"#"!0'.)5)7#K #(7)063,5(#31:&03
).40-.)"#,)7#3#" :03").3:13)-3:!3#1#340..#,).'#.#3,-#")!,13!5)!#D3."0-);#"
!0.530,,#"#&&#!5)7#.#4453),E',)&$'*$()*) E[YZ\C[[O_PD_aaJ_b_E
\^E
!633:B(0353##"B0.03&&B#5,E(0 #.#&)54&30-&03).40-.)).13)-3:
!3# 
-1035.515)#.54#,#!5)0.."53),"#4)'.,#440.4&30-,0.')56").,3#46,540&5(#)&#45:,#4
53),E$(E[YZ]C\`O[PD[bbJ\YaE
\_E
(0!(5B-1(3#44B
43#,B.!0,)J
43#,E
.40-.)).13)-3:!3#15)#.54E$(2',)&$
'$(*) 8$(!!&E6 ,)4(#"0.,).#ZbbbE
\`E
03).B005;).B6:44#B").'#3B41)#B)!(45#).E4:!(0,0')!,." #(7)03,
53#5-#.50&).40-.)D61"5#0&5(#3#!#.5#7)"#.!#OZbbaJ[YY]PE$(E[YY_C[bOZZPDZ\baJZ]Z]E
\aE
!(655#J0").B30!(B6:44#B034#:B5#)E,).)!,'6)"#,).#&035(##7,65)0.."
-.'#-#.50&!(30.)!).40-.))."6,54E',)&$'$!&!$*$(%!!&E[YYaC]O^PD]a`J^Y]E
\bE
03).B%,.'#3B#,.!B#5,E(#.563,()4503:0&).40-.)D1016,5)0.J 4#"\J:#3
,0.')56").,456":E) !-*'!&+)&$%!!&E[YYbCZ_bO^PD]]`J]^\E
]YE
%'#3B:0.E0!)#5,!04540&).40-.)E$(%!!&)-!.*E[YZYCZ]O_PD\`bJ\abE
]ZE
364B ).E,##1-#3)!D-.').'5(#!3)4)40&"6,5!(30.)!).40-.)."440!)5#"
!0.")5)0.4E',)&$'+!-!*'))*E[YZ[CZ\aO\PDZb[J[Z[E

(+&"+#(+-.26'(&"3('-+(%%+"%(.%-.+%%2)-" "-%+-&'-(( '"-"/:
!/"(+%!+)2(+
',(&'"(+)'",!)$"' -"'9(+"&+2+-"'-,
@G2A?AA

	3050!0,#-1,5#&03#(7)03,."0!),!)#.!#4#4#3!(
][E
6,)5:&	E-!&5*)+!&+)0*+%!-!.)'+''$)'"+!+$2!&'*!*
&)+%&+'
&*'%&!!*'))EC[YZ]E
]\E
)B(.'B).+#,-.B#5,E440!)5)0. #58##.).40-.)4:-150-4."-035,)5:D
13041#!5)7#456":0&-#.E!),$+!'&E[YZ]CZ[bO`PD`\`J`]_E
]]E
(),,)14B..).0E0).40-.)!0-1,).54!64#(:1#35#.4)0.03!3")074!6,3")4#4#
',)&$'$!&!$$(!!&E[YY`C\O^PD]abJ]b]E
]^E
6+B04()"B6')-03)	E#34)45#.5).40-.))413#")!5030&(:1#35#.4)0.).1.#4#-,#
803+#34E',)&$'',(+!'&$ $+ E[YY\C]^O_PD\]]J\^YE
]_E
03+07#!B0 ).40.B36;).4+:B#3##E3#,)-).3:#91,035)0.0&8033:D0-#
!(3!5#3)45)!4."130!#44#4E -!',))*) &+ )(0EZba\C[ZOZPDbJZ_E
]`E
309#,B6:44#B55(#84B#5,E,##14:-150-413#")!55(#"#7#,01-#.50&5(#
-#5 0,)!4:."30-#E$(E[YZYC\\OZ[PDZ_\\JZ_]YE
]aE
6'4."B55#.B,506B.4;+:
E
.40-.)."5(#3)4+0&!65#-:0!3"),).&3!5)0.D
1016,5)0.456":E!),$+!'&E[YZZCZ[]OZbPD[Y`\J[YaZE
]bE
0"	B(5#3B#45#3,6."	B#5,E,##1")4563 .!#4."!64#J41#!)&)!-035,)5:D3#46,54
&30-5(#!0(035456":E%)!&"',)&$'(!%!'$'0E[YZZCZ`\O\PD\YYJ\YbE
^YE
46.0B#44#5B)5!()#E,##1.""#13#44)0.E',)&$'$!&!$(*0 !+)0E[YY^C__OZYPDZ[^]J
Z[_bE
^ZE
',)0.)B55',)#4#B#)'#B#5,E
.40-.)413#")!5030&"#13#44)0.D-#5J.,:5)!
#7,65)0.0&,0.')56").,#1)"#-)0,0')!,456")#4E+!*')E[YZZCZ\^OZJ\PDZYJZbE
"0)DZYEZYZ_I*E*"E[YZZEYZEYZZ
^[E
)#-..B0"#3(0,;#3E3)-3:).40-.)D3)4+&!50350"#7#,01"#13#44)0. ',)&$'
+!-!*'))*E[YY\C`_OZJ\PD[^^J[^bE
^\E
(#.'BE4#-#.5B(#.JB	0&&-..B3-)5'#B#,").E,##1J")403"#3#"
 3#5().').-*03"#13#44)7#")403"#3E',)&$'*$()*) E[YZ\C[[O]PD]^bJ]_[E
^]E
,730B0 #354B	33)4E:45#-5)!#7)#844#44).')")3#!5)0.,)5: #58##.,##1
)4563 .!#4B.9)#5:B."#13#44)0.E$(E[YZ\C\_O`PDZY^bJZY_aE"0)DZYE^__^I4,##1E[aZY
^^E
(#.B.'B##B#5,E!),I5(.)!)&&#3#.!#4).,##1)4563 .!#4D(#6,5)J5(.)!
56":0&5(#304!,#304)4OPE$(E[YZ^C\aO_PDa``JaaaE"0)DZYE^__^I4,##1E]`\[
^_E
,!.53B5#,B3.#5(0.B#5,E53#44.",##1D#46,54&30-5(#	)41.)!0--6.)5:
	#,5(56":I56":0&5).040!)0!6,563,.!),,3:56":E'(,$	$+ E[YZ`C\D`Z\J`[ZE
"0)DZYEZYZ_I*E44-1(E[YZ`EYaEYY]

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
57.
Davy Z, Middlemass J, Siriwardena AN. Patients’ and clinicians’ experiences and perceptions of the
primary care management of insomnia: qualitative study. Health Expectations. 2015;18(5):1371-
1383. 
58.
Dyas JV, Apekey TA, Tilling M, Ørner R, Middleton H, Siriwardena AN. Patients’ and clinicians’
experiences of consultations in primary care for sleep problems and insomnia: a focus group study.
British Journal of General Practice. 2010;60(574):e180-e200.
59.
Morin CM, Colecchi C, Stone J, Sood R, Brink D. Behavioral and pharmacological therapies for late-
life insomnia: a randomized controlled trial. Jama. 1999;281(11):991-999.
60.
Smith MT, Perlis ML, Park A, et al. Comparative meta-analysis of pharmacotherapy and behavior
therapy for persistent insomnia. American Journal of Psychiatry. 2002;159(1):5-11.
61.
Jacobs GD, Pace-Schott EF, Stickgold R, Otto MW. Cognitive behavior therapy and
pharmacotherapy for insomnia: a randomized controlled trial and direct comparison. Archives of
internal medicine. 2004;164(17):1888-1896.
62.
Morin C, Culbert J, Schwartz S. Nonpharmacological intervetnions for insomnia: A meta-analysis of
treatment efficacy. Am J Psychiatry. 1994;(151):1172-1180.
63.
Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for
Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015;163(3):191-204.
doi:10.7326/m14-2841
64.
Mitchell MD, Gehrman P, Perlis M, Umscheid CA. Comparative effectiveness of cognitive
behavioral therapy for insomnia: a systematic review. BMC Family Practice. 2012;13(1):40.
doi:10.1186/1471-2296-13-40
65.
Hampton LM, Daubresse M, Chang HY, Alexander GC, Budnitz DS. Emergency department visits by
adults for psychiatric medication adverse events. JAMA Psychiatry. 2014;71(9):1006-1014.
doi:10.1001/jamapsychiatry.2014.436
66.
Hall GCN, Ibaraki AY, Huang ER, Marti CN, Stice E. A meta-analysis of cultural adaptations of
psychological interventions. Behavior therapy. 2016;47(6):993-1014.
67.
Griner D, Smith TB. Culturally adapted mental health intervention: A meta-analytic review.
Psychotherapy (Chic). 2006;43(4):531-548. doi:10.1037/0033-3204.43.4.531
68.
Admnistration Sa. Results from the 2012 National Survey on Drug Use and Health: Mental Health
Findings.; 2013.
69.
Espie CA, Fleming L, Cassidy J, et al. Randomized controlled clinical effectiveness trial of cognitive
behavior therapy compared with treatment as usual for persistent insomnia in patients with
cancer. Journal of clinical oncology. 2008;26(28):4651-4658.

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
70.
Espie CA, Inglis SJ, Harvey L. Predicting clinically significant response to cognitive behavior therapy
for chronic insomnia in general medical practice: Analyses of outcome data at 12 months
posttreatment. Journal of consulting and clinical psychology. 2001;69(1):58.
71.
Trockel M, Karlin BE, Taylor CB, Manber R. Cognitive behavioral therapy for insomnia with
veterans: evaluation of effectiveness and correlates of treatment outcomes. Behaviour research
and therapy. 2014;53:41-46.
72.
Manber R, Steidtmann D, Chambers AS, Ganger W, Horwitz S, Connelly CD. Factors associated with
clinically significant insomnia among pregnant low-income Latinas. J Womens Health (Larchmt).
2013;22(8):694-701. doi:10.1089/jwh.2012.4039
73.
McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research evaluating brief behavioral sleep
treatments for rural elderly (RESTORE): A preliminary examination of effectiveness. The American
Journal of Geriatric Psychiatry. 2007;15(11):979-982.
74.
Vitiello MV, McCurry SM, Shortreed SM, et al. Cognitive-behavioral treatment for comorbid
insomnia and osteoarthritis pain in primary care: The lifestyles randomized controlled trial. Journal
of the American Geriatrics Society. 2013;61(6):947-956.
75.
Zickuhr K, Smith A. Digital differences. Pew Research Center: Internet, Science & Tech. Published
2012. Accessed June 24, 2021. https://www.pewresearch.org/internet/2012/06/25/digital-
differences-3/
76.
Perrin A. Smartphones help balcks, hispanics bridge some- but not all- digital gaps with whites.
77.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs:
combining elements of clinical effectiveness and implementation research to enhance public
health impact. Medical care. 2012;50(3):217.
78.
Freedland KE, Mohr DC, Davidson KW, Schwartz JE. Usual and unusual care: existing practice
control groups in randomized controlled trials of behavioral interventions. Psychosomatic
medicine. 2011;73(4):323.
79.
Barrera M, Castro FG, Strycker LA, Toobert DJ. Cultural Adaptations of Behavioral Health
Interventions: A Progress Report. J Consult Clin Psychol. 2013;81(2):196-205.
doi:10.1037/a0027085
80.
Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: Psychometric Indicators to
Detect Insomnia Cases and Evaluate Treatment Response. Sleep. 2011;34(5):601-608.
doi:10.1093/sleep/34.5.601
81.
Fernandez-Mendoza J, Rodriguez-Muñoz A, Vela-Bueno A, et al. The Spanish version of the
Insomnia Severity Index: A confirmatory factor analysis. Sleep Medicine. 2012;13(2):207-210.
doi:10.1016/j.sleep.2011.06.019

Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Treatment of  Cognitive-
Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients  
18 May 2022 
NIH Protocol Template for Behavioral and Social Sciences Research 
82.
Turner-Bowker D, Hogue SJ. Short Form 12 Health Survey (SF-12). In: Michalos AC, ed.
Encyclopedia of Quality of Life and Well-Being Research. Springer Netherlands; 2014:5954-5957.
doi:10.1007/978-94-007-0753-5_2698
83.
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. sleep.
1991;14(6):540-545.
84.
Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation
of the patient assessment of chronic illness care (PACIC). Medical care. Published online 2005:436-
444. 
85.
Kushida CA, Chang A, Gadkary C, Guilleminault C, Carrillo O, Dement WC. Comparison of
actigraphic, polysomnographic, and subjective assessment of sleep parameters in sleep-disordered
patients. Sleep medicine. 2001;2(5):389-396.
86.
Buysse DJ, Reynolds III CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a
new instrument for psychiatric practice and research. Psychiatry research. 1989;28(2):193-213.
87.
Tomfohr LM, Schweizer CA, Dimsdale JE, Loredo JS. Psychometric characteristics of the Pittsburgh
Sleep Quality Index in English speaking non-Hispanic whites and English and Spanish speaking
Hispanics of Mexican descent. J Clin Sleep Med. 2013;9(1):61-66. doi:10.5664/jcsm.2342