Clinical trial NCT05353296: Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Behavioral Sleep Medicine
Digital Health
Hispanic
Latino
Sociocultural
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-04-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel-group, single-site, 2-arm Hybrid trial Type-1 effectiveness-implementation study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean Insomnia Severity Index Score (ISI)
timeFrame: Baseline to post-intervention (9 weeks)
measure: Change in Mean Insomnia Severity Index Score (ISI)
timeFrame: Baseline to 6 months post intervention
Secondary outcomes:
measure: Change in Mean Quality of Life Score (Short-Form 12 [SF-12])
timeFrame: Baseline to post-intervention (9 weeks)
measure: Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS)
timeFrame: Baseline to post-intervention (9 weeks)
measure: Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC)
timeFrame: Baseline to post-intervention (9 weeks)
Other outcomes:
measure: Change in Mean Sleep Quality Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to post-intervention (9 weeks)
measure: Change in Mean Self-reported Wake After Sleep Onset
timeFrame: Baseline to post-intervention (9 weeks)
measure: Change in Mean Actigraphy Assessed Wake After Sleep Onset
timeFrame: Baseline to post-intervention (9 weeks)
measure: Change in Mean Self-reported Sleep Onset Latency
timeFrame: Baseline to post-intervention (9 weeks)
Locations:
city: New York
country: United States
facility: Columbia School of Social Work
state: New York
Study officials:
affiliation: Columbia School of Social Work
name: Carmela Alcantara, PhD
role: PRINCIPAL_INVESTIGATOR
References: