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

Browse trials for

• Sleep Initiation and Maintenance Disorders 1,856

Keywords

• Insomnia
• Behavioral Sleep Medicine
• Digital Health
• Hispanic
• Latino
• Sociocultural

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 7 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Study arms

• Experimental
  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.

  Behavioral: Digital cognitive behavioral therapy for insomnia (CBT-I) program · Device: Somryst (culturally adapted)

• Active comparator
  Minimally Enhanced Usual Care (mEUC)

  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.

  Behavioral: Minimally Enhanced Usual Care (mEUC)

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.

Primary outcomes

1. 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)

2. 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

1. 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)

2. 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)

3. 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)

Other outcomes

1. 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)

2. 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)

3. 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)

4. 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)

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · May 18, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Upon request, we plan to make available a de-identified database that includes ISI data, demographics and comorbidity characteristics of patients in our study.

Supporting information: Study protocol, Sap