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

Not Applicable

Completed

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)	Somryst (culturally adapted)	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.
Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)	Digital cognitive behavioral therapy for insomnia (CBT-I) program	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.
Minimally Enhanced Usual Care (mEUC)	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.

Primary Outcome Measures

Name	Time	Method
Change in Mean Insomnia Severity Index Score (ISI)	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 Outcome Measures

Name	Time	Method
Change in Mean Quality of Life Score (Short-Form 12 [SF-12])	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.
Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS)	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.
Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC)	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)