Back to resultsDigital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)
Primary Purpose
Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital cognitive behavioral therapy for insomnia (CBT-I) program
Minimally Enhanced Usual Care (mEUC)
Somryst (culturally adapted)
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Behavioral Sleep Medicine, Digital Health, Hispanic, Latino, Sociocultural
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
Sites / Locations
- Columbia School of Social WorkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)
Minimally Enhanced Usual Care (mEUC)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05353296
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Behavioral Sleep Medicine, Digital Health, Hispanic, Latino, Sociocultural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a parallel-group, single-site, 2-arm Hybrid trial Type-1 effectiveness-implementation study
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to treatment condition
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)
Arm Type
Experimental
Arm Description
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.
Arm Title
Minimally Enhanced Usual Care (mEUC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digital cognitive behavioral therapy for insomnia (CBT-I) program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Minimally Enhanced Usual Care (mEUC)
Intervention Description
A minimally enhanced usual care, which will include usual care by patients' Primary Care Provider and a sleep hygiene brochure.
Intervention Type
Device
Intervention Name(s)
Somryst (culturally adapted)
Intervention Description
FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep.
Primary Outcome Measure Information:
Title
Change in mean insomnia severity index score (ISI)
Description
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)
Title
Change in mean insomnia severity index score (ISI)
Description
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 Outcome Measure Information:
Title
Change in mean quality of life score (Short-Form 12 [SF-12])
Description
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.
Time Frame
Baseline to post-intervention (9 weeks)
Title
Change in mean daytime sleepiness- Epworth Sleepiness Scale (ESS)
Description
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)
Title
Change in mean Satisfaction with Care Patient Assessment of Chronic Illness Care (PACIC)
Description
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)
Other Pre-specified Outcome Measures:
Title
Change in mean Sleep quality Pittsburgh Sleep Quality Index (PSQI)
Description
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)
Time Frame
Baseline to post-intervention (9 weeks)
Title
Change in mean self-reported wake after sleep onset
Description
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)
Time Frame
Baseline to post-intervention (9 weeks)
Title
Change in mean actigraphy assessed wake after sleep onset
Description
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)
Time Frame
Baseline to post-intervention (9 weeks)
Title
Change in mean self-reported sleep onset latency
Description
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)
Time Frame
Baseline to post-intervention (9 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria F Murillo, BS
Phone
212-853-0248
Email
mfm2187@columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carmela Alcantara, PhD
Phone
212-851-2187
Email
ca2543@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmela Alcantara, PhD
Organizational Affiliation
Columbia School of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia School of Social Work
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria F Murillo, BS
Phone
212-853-0248
Email
dormirmejor@columbia.edu
Phone
212-854-9220
Email
sleepmindhealth@columbia.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request, we plan to make available a de-identified database that includes ISI data, demographics and comorbidity characteristics of patients in our study.
IPD Sharing Time Frame
Within 1 year of publication of trial primary outcome results
IPD Sharing Access Criteria
De-identified database
Learn more about this trial
Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)
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