Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)

Study Overview
=================
Brief Summary
-----------------
The primary objective of the proposed study is to examine the effectiveness of a culturally adapted digital program of cognitive behavioral therapy for insomnia (CBT-I) 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 among Spanish-Speaking Latina/o adults with chronic insomnia.

Detailed Description
-----------------
Chronic insomnia is associated with significant public health burden and most adults seek care for insomnia in the primary care setting. While Latina/os are at greater risk for insomnia than non-Hispanic Whites, access to the recommended first-line of treatment, cognitive behavioral therapy for insomnia, is limited especially for Spanish-speakers. Recent advances in health information technology such as self-guided digital health treatments represent an innovative and scalable means to address the supply and demand imbalance that perpetuate mental health care disparities, however its implementation in underserved communities remains elusive. The purpose of this study is to compare the effectiveness of a culturally adapted digital version of Cognitive Behavioral Therapy for Insomnia with minimally enhanced usual care on reduction of insomnia symptoms among Spanish-speaking Latina/os adults with chronic insomnia. The study will also examine barriers and facilitators to implementation, and examine cost-effectiveness of the intervention.

Official 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

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Behavioral: Digital cognitive behavioral therapy for insomnia (CBT-I) program
* Behavioral: Minimally Enhanced Usual Care (mEUC)
* Device: Somryst (culturally adapted)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insomnia Severity Index Score for moderate insomnia symptoms (score>10 on ISS) Spanish-speaking or bilingual (English and Spanish) and self-identify as Hispanic or Latina/o Report experience of sleep disturbances for at least 3x/week and for at least 3 months Exclusion Criteria: Pregnancy Excessive sleepiness (score>=16 on ESS) Caregivers of infants (< 3 months) and/or of adults who require care at night Participants who are deemed unable to complete the study protocol due to dementia, severe cognitive impairment, severe medical or mental illness, or active substance use disorder Untreated moderate to severe obstructive sleep apnea or self-reported narcolepsy Unstable depression or insomnia medication regimen Patients who have full-time transportation/moving occupations Participation in another treatment/intervention study within the time period of initial baseline until the 6-month follow-up assessments Participation in regular night shift work, more than 1x/week, or non-standard sleep patterns

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a parallel-group, single-site, 2-arm Hybrid trial Type-1 effectiveness-implementation study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)<br>Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Group will have access to this culturally-adapted Somryst, along with the usual care provided by their primary care provider, and will be provided a sleep hygiene brochure during group assignment. | Behavioral: Digital cognitive behavioral therapy for insomnia (CBT-I) program<br>* A self-guided digital program of CBT-I (Somryst) that has been culturally adapted for Spanish-language speakers. Somryst is an interactive and tailored mobile-based program modeled on the primary tenets of face-to-face CBT-I. Patients will be asked to complete six cores (main intervention content) during the 9-week intervention period. The cores provide key content across six domains including behavioral (sleep restriction, stimulus control), cognitive (cognitive restricting), educational (sleep hygiene), overview, and consolidation/relapse prevention.<br>Device: Somryst (culturally adapted)<br>* FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep.<br>|
| Active Comparator: Minimally Enhanced Usual Care (mEUC)<br>Usual care by their primary care provider and a sleep hygiene brochure. Group will continue their typical standard care with their primary care provider, which may include pharmacotherapy. In addition, we will provide a sleep hygiene brochure during group assignment. | Behavioral: Minimally Enhanced Usual Care (mEUC)<br>* A minimally enhanced usual care, which will include usual care by patients' Primary Care Provider and a sleep hygiene brochure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean insomnia severity index score (ISI) | ISI is a 7-item self-report scale measuring insomnia symptom severity in the last 2 weeks; summed score ranges 0-28, increasing score associated with increasing severity. | Baseline to post-intervention (9 weeks) | 
| Change in mean insomnia severity index score (ISI) | ISI is a 7-item self-report scale measuring insomnia symptom severity in the last 2 weeks; summed score ranges 0-28, increasing score associated with increasing severity. | Baseline to 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean quality of life score (Short-Form 12 [SF-12]) | Short Form (SF)-12 is a 12-item self-report inventory that generically measures quality of life; yields a measure of global health-related wellbeing as 8 domain-specific subscores on a 0-100 scale, increasing score reflects less dysfunction, impairment, or pain. | Baseline to post-intervention (9 weeks) | 
| Change in mean daytime sleepiness- Epworth Sleepiness Scale (ESS) | ESS is an 8-item brief self-report scale of daytime sleepiness; summed scores range 0-24, where increasing scores constitute greater sleepiness, and a score > 11 represents elevated daytime sleepiness. | Baseline to post-intervention (9 weeks) | 
| Change in mean Satisfaction with Care Patient Assessment of Chronic Illness Care (PACIC) | PACIC is a 20-item scale containing 5 subscales, adapted for this trial to measure respondents' receipt of services in regards to insomnia in the past 6 months, 5-point scale, range of 20-100 with increasing score reflecting greater satisfaction with care) | Baseline to post-intervention (9 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Behavioral Sleep Medicine, Digital Health, Hispanic, Latino, Sociocultural