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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05353296
• Other study ID #: AAAS0318
• Secondary ID: R01HS024274
• Status: Completed
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: January 5, 2024

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Device:
• Somryst (culturally adapted)
FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep.

Locations

Country	Name	City	State
United States	Columbia School of Social Work	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in mean Sleep quality Pittsburgh Sleep Quality Index (PSQI)	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)	Baseline to post-intervention (9 weeks)
Other	Change in mean self-reported wake after sleep onset	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)	Baseline to post-intervention (9 weeks)
Other	Change in mean actigraphy assessed wake after sleep onset	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)	Baseline to post-intervention (9 weeks)
Other	Change in mean self-reported sleep onset latency	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)	Baseline to post-intervention (9 weeks)
Primary	Change in mean insomnia severity index score (ISI)	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.	Baseline to post-intervention (9 weeks)
Primary	Change in mean insomnia severity index score (ISI)	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.	Baseline to 6 months post intervention
Secondary	Change in mean quality of life score (Short-Form 12 [SF-12])	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.	Baseline to post-intervention (9 weeks)
Secondary	Change in mean daytime sleepiness- Epworth Sleepiness Scale (ESS)	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.	Baseline to post-intervention (9 weeks)
Secondary	Change in mean Satisfaction with Care Patient Assessment of Chronic Illness Care (PACIC)	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)	Baseline to post-intervention (9 weeks)