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

Columbia University

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Digital cognitive behavioral therapy for insomnia (CBT-I) program; Device: Somryst (culturally adapted); Behavioral: Minimally Enhanced Usual Care (mEUC)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05353296

R01HS024274 (U.S. AHRQ Grant/Contract)

AAAS0318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: Somryst (culturally adapted)

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

Minimally Enhanced Usual Care (mEUC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Minimally Enhanced Usual Care (mEUC)