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Completed

NCT Number: NCT05353296

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia School of Social Work

New York, 10027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Mean Insomnia Severity Index Score (ISI)

    Time frame: Baseline to post-intervention (9 weeks)

    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.

  2. Change in Mean Insomnia Severity Index Score (ISI)

    Time frame: Baseline to 6 months post intervention

    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.

Secondary outcomes

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

    Time frame: Baseline to post-intervention (9 weeks)

    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.

  2. Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS)

    Time frame: Baseline to post-intervention (9 weeks)

    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.

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

    Time frame: Baseline to post-intervention (9 weeks)

    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)

Other outcomes

  1. Change in Mean Sleep Quality Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline to post-intervention (9 weeks)

    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)

  2. Change in Mean Self-reported Wake After Sleep Onset

    Time frame: Baseline to post-intervention (9 weeks)

    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)

  3. Change in Mean Actigraphy Assessed Wake After Sleep Onset

    Time frame: Baseline to post-intervention (9 weeks)

    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)

  4. Change in Mean Self-reported Sleep Onset Latency

    Time frame: Baseline to post-intervention (9 weeks)

    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)

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2022
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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