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

Columbia University7 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Insomnia

Interventions

Digital cognitive behavioral therapy for insomnia (CBT-I) programBEHAVIORAL

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)BEHAVIORAL

A minimally enhanced usual care, which will include usual care by patients' Primary Care Provider and a sleep hygiene brochure.

Somryst (culturally adapted)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Columbia School of Social Work

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to post-intervention (9 weeks)

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.

Time frame: Baseline to 6 months post intervention

Secondary Outcomes

Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score)

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. Reporting change in mean mental health component score.

Time frame: Baseline to post-intervention (9 weeks)

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.

Time frame: Baseline to post-intervention (9 weeks)

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)

Time frame: Baseline to post-intervention (9 weeks)

Data from ClinicalTrials.gov

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