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

NCT05353296 | Completed Results DMC FDA Device

• 2 other identifiers: AAAS0318R01HS024274
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Behavioral Sleep Medicine; Digital Health; Hispanic; Latino; Sociocultural

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score)

  Baseline to post-intervention (9 weeks)

• Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS)

  Baseline to post-intervention (9 weeks)

• Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC)

  Baseline to post-intervention (9 weeks)

Other Outcomes (4)

• Change in Mean Sleep Quality Pittsburgh Sleep Quality Index (PSQI)

  Baseline to post-intervention (9 weeks)

• Change in Mean Self-reported Wake After Sleep Onset

  Baseline to post-intervention (9 weeks)

• Change in Mean Actigraphy Assessed Wake After Sleep Onset

  Baseline to post-intervention (9 weeks)

Study Arms (2)

Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)

EXPERIMENTAL

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; Device: Somryst (culturally adapted)

Minimally Enhanced Usual Care (mEUC)

ACTIVE COMPARATOR

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)

Interventions

Digital cognitive behavioral therapy for insomnia (CBT-I) program BEHAVIORAL

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.

Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)

Minimally Enhanced Usual Care (mEUC) BEHAVIORAL

A minimally enhanced usual care, which will include usual care by patients' Primary Care Provider and a sleep hygiene brochure.

Minimally Enhanced Usual Care (mEUC)

Somryst (culturally adapted) DEVICE

FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep.

Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Columbia School of Social Work

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Carmela Alcantara, PhD
• Organization: Columbia University

ca2543@cumc.columbia.edu

212-851-2187

Study Officials

• Carmela Alcantara, PhD

  Columbia School of Social Work

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a parallel-group, single-site, 2-arm Hybrid trial Type-1 effectiveness-implementation study

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 29, 2022
• Study Start: April 7, 2022
• Primary Completion: January 5, 2024
• Study Completion: July 15, 2024
• Last Updated: August 1, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 1 year of publication of trial primary outcome results
• Access Criteria: De-identified database

Locations

US (1)