CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Digital cognitive behavioral therapy for insomnia (CBT-I) program +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05353296
NCT05353296N/ACompleted

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

Columbia University·interventional·Posted Apr 29, 2022·Updated Aug 1, 2025

In Brief

A clinical study evaluating Digital cognitive behavioral therapy for insomnia (CBT-I) program, Minimally Enhanced Usual Care (mEUC), and 1 other intervention for Insomnia. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 29, 2022
Enrollment StartApr 7, 2022
Primary CompletionJan 5, 2024
Study CompletionJul 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.2 years ago

Interventions

Digital cognitive behavioral therapy for insomnia (CBT-I) programbehavioral

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.

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.

Somryst (culturally adapted)device

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