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

NCT ID: NCT05353296

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-07
• Study Completion Date: 2024-07-15

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Somryst (culturally adapted)

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Minimally Enhanced Usual Care (mEUC)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Somryst (culturally adapted)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Carmela Alcantara

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmela Alcantara, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia School of Social Work

Locations

Columbia School of Social Work

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HS024274

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

AAAS0318

Identifier Type: -

Identifier Source: org_study_id