Insomnia
Conditions
Keywords
Insomnia, Behavioral Sleep Medicine, Digital Health, Hispanic, Latino, Sociocultural
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.
Interventions
BEHAVIORALDigital 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.
BEHAVIORALMinimally Enhanced Usual Care (mEUC)
A minimally enhanced usual care, which will include usual care by patients' Primary Care Provider and a sleep hygiene brochure.
DEVICESomryst (culturally adapted)
FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to treatment condition
Intervention model description
This is a parallel-group, single-site, 2-arm Hybrid trial Type-1 effectiveness-implementation study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score) | 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. Reporting change in mean mental health component score. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. Participants 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. | 3 |
| Minimally Enhanced Usual Care (mEUC) Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment. | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst) | Total | Minimally Enhanced Usual Care (mEUC) |
|---|---|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 12.1 | 49.2 years STANDARD_DEVIATION 14.6 | 52.4 years STANDARD_DEVIATION 17.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 3 participants | 7 participants | 4 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
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.
Time frame: Baseline to post-intervention (9 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst) | Change in Mean Insomnia Severity Index Score (ISI) | -6.7 score on a scale |
| Minimally Enhanced Usual Care (mEUC) | Change in Mean Insomnia Severity Index Score (ISI) | -3.9 score on a scale |
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.
Time frame: Baseline to 6 months post intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst) | Change in Mean Insomnia Severity Index Score (ISI) | -5.7 score on a scale |
| Minimally Enhanced Usual Care (mEUC) | Change in Mean Insomnia Severity Index Score (ISI) | -1.6 score on a scale |
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.
Time frame: Baseline to post-intervention (9 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst) | Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS) | -2.3 score on a scale |
| Minimally Enhanced Usual Care (mEUC) | Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS) | 0.5 score on a scale |
Secondary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst) | Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score) | 10.8 score on a scale |
| Minimally Enhanced Usual Care (mEUC) | Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score) | 0.8 score on a scale |
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)
Time frame: Baseline to post-intervention (9 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst) | Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC) | 17.4 score on a scale |
| Minimally Enhanced Usual Care (mEUC) | Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC) | -8.2 score on a scale |
Other Pre-specified
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)
Time frame: Baseline to post-intervention (9 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst) | Change in Mean Actigraphy Assessed Wake After Sleep Onset | -2.5 minutes |
| Minimally Enhanced Usual Care (mEUC) | Change in Mean Actigraphy Assessed Wake After Sleep Onset | -4.8 minutes |
Other Pre-specified
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)
Time frame: Baseline to post-intervention (9 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst) | Change in Mean Self-reported Sleep Onset Latency | -53.3 minutes |
| Minimally Enhanced Usual Care (mEUC) | Change in Mean Self-reported Sleep Onset Latency | -16.9 minutes |
Other Pre-specified
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)
Time frame: Baseline to post-intervention (9 weeks)
Population: This outcome is not able to be analyzed because data not collected.
Other Pre-specified
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)
Time frame: Baseline to post-intervention (9 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst) | Change in Mean Sleep Quality Pittsburgh Sleep Quality Index (PSQI) | -1.0 score on a scale |
| Minimally Enhanced Usual Care (mEUC) | Change in Mean Sleep Quality Pittsburgh Sleep Quality Index (PSQI) | -0.7 score on a scale |