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

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05353296

Collaborator

(none)

200

Enrollment

Location

Arms

21.8

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: Digital cognitive behavioral therapy for insomnia (CBT-I) program Behavioral: Minimally Enhanced Usual Care (mEUC) Device: Somryst (culturally adapted)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a parallel-group, single-site, 2-arm Hybrid trial Type-1 effectiveness-implementation studyThis is a parallel-group, single-site, 2-arm Hybrid trial Type-1 effectiveness-implementation study

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcome assessors will be blinded to treatment condition

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Apr 7, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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. Device: Somryst (culturally adapted) FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Device: Somryst (culturally adapted)

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

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

Change in mean insomnia severity index score (ISI) [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.
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

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)

Other Outcome Measures

Change in mean Sleep quality Pittsburgh Sleep Quality Index (PSQI) [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)
Change in mean self-reported wake after sleep onset [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)
Change in mean actigraphy assessed wake after sleep onset [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)
Change in mean self-reported sleep onset latency [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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