| 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. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to post-intervention (9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-6.7(-15.4 to 2.0)
- OG001-3.9(-12.5 to 4.7)
|
|
| |
| 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. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to 6 months post intervention | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to post-intervention (9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. 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. Somryst (culturally adapted): FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep. |
|
| 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. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to post-intervention (9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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) | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to post-intervention (9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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) | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to post-intervention (9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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) | This outcome is not able to be analyzed because data not collected. | Posted | | | | | | Baseline to post-intervention (9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. 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. Somryst (culturally adapted): FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep. |
|
| 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) | | Posted | | Mean | 95% Confidence Interval | minutes | | Baseline to post-intervention (9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. 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. Somryst (culturally adapted): FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep. | | OG001 |
|
| 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) | | Posted | | Mean | 95% Confidence Interval | minutes | | Baseline to post-intervention (9 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. 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. Somryst (culturally adapted): FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep. | | OG001 |
|