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

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Digital cognitive behavioral therapy for insomnia (CBT-I) program; Device: Somryst (culturally adapted); Behavioral: Minimally Enhanced Usual Care (mEUC)

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst); 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; 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.; Device: Somryst (culturally adapted); FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep.
Active Comparator: Minimally Enhanced Usual Care (mEUC); 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); A minimally enhanced usual care, which will include usual care by patients' Primary Care Provider and a sleep hygiene brochure.

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 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)
Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score)	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. Reporting change in mean mental health component score.	Baseline to post-intervention (9 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Sleep Quality Pittsburgh Sleep Quality Index (PSQI)	PSQI is an 18-item questionnaire of sleep quality in the past month, summed scores range 0-21, where scores >5 are associated with poor sleep quality and <5 with good sleep quality)	Baseline to post-intervention (9 weeks)
Change in Mean Self-reported Wake After Sleep Onset	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. Range: 24 hours Minimum value = 0 minutes (better) Maximum value = 1440 minutes (worse)	Baseline to post-intervention (9 weeks)
Change in Mean Actigraphy Assessed Wake After Sleep Onset	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)	Baseline to post-intervention (9 weeks)
Change in Mean Self-reported Sleep Onset Latency	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)	Baseline to post-intervention (9 weeks)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Carmela Alcantara, PhD, Columbia School of Social Work

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Insomnia; Digital Health; Hispanic; Latino; Behavioral Sleep Medicine; Sociocultural
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: AAAS0318; R01HS024274 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request, we plan to make available a de-identified database that includes ISI data, demographics and comorbidity characteristics of patients in our study.
• IPD Sharing Time Frame: Within 1 year of publication of trial primary outcome results
• IPD Sharing Access Criteria: De-identified database
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No