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

  • STATUS
    Recruiting
  • End date
    Feb 11, 2024
  • participants needed
    200
  • sponsor
    Columbia University
Updated on 11 May 2022
behavior therapy
sleep disturbances
cognitive behavioral therapy for insomnia
chronic insomnia

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.

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.

Details
Condition Insomnia
Treatment Minimally Enhanced Usual Care (MEUC), Digital cognitive behavioral therapy for insomnia (CBT-I) program, Somryst (culturally adapted)
Clinical Study IdentifierNCT05353296
SponsorColumbia University
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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