Online Insomnia Treatment Program

Study Overview
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Brief Summary
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The purpose of this study is to investigate improvements in sleep by comparing two 6-week digital programs, either online or app-based, that deliver Cognitive Behavioral Therapy for Insomnia (CBT-I), the gold standard treatment for insomnia, with or without a bedside device to help track sleep.

Detailed Description
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Time needed from participant: 15 minutes per day to complete an app-based or online sleep diary and review information in an app-based or online CBT-I program. To qualify, you must: Be 18+ years old Have a diagnosis of insomnia or suspected insomnia Have access to the internet and an iphone, Android or other smart phone device Coordinator Contact: Cris Moreno (650) 721-7576 crismore@stanford.edu

Official Title
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A Study on Online Insomnia Treatment Programs

Conditions
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Insomnia, Sleep, Sleep Disturbance, Sleep Disorder, Sleep Hygiene, Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Behavioral: Full Sleep
* Behavioral: Path to Better Sleep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: insomnia diagnosis or measure-confirmed moderate to severity insomnia (Insomnia Severity Index = 15-28) access to an iPhone with iOS 11+ or Samsung, Google, HTC, LG, OnePlus, or Motorola phone with Android 10+ 18 years of age or older available 15 mins per day to participate Exclusion Criteria: Restless Legs Syndrome narcolepsy sleep apnea sleep walking bipolar disorder seizures disorder substance abuse frailty/risk of falling severe memory problems shift work change in antidepressant medication within past 2 months serious mental/physical health problem other ongoing psychological treatment w sleeping with pets. Participants should be aware that should they receive a device, its sound and light alerts could be disruptive to partners or others (e.g., children) that sleep in the same room.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full Sleep<br>With Full Sleep, the app provides daily lessons about sleep and skills that can help with sleep. In the app, participants also record information about each night's sleep in their sleep log. Every seven nights, they also complete the Sleep Needs Questionnaire. At the beginning, middle, and end of the study, they additionally complete the Insomnia Severity Inventory in the app. At the end of every week, a sleep schedule and weekly summary are calculated via automated formulas. The app also contains access to messaging a coach. The intent of coach access is for participants to ask questions about their daily lessons and application of the skills and to feel supported and accountable. The REST (Radar Enabled Sensing Technology) device in the Full Sleep program uses radar to passively track sleep patterns and nighttime awakenings. It also offers white noise options and audio guidance for relaxation techniques and stimulus control. | Behavioral: Full Sleep<br>* Daily lessons about sleep and skills that can help with sleep. Participants also record information about each night's sleep in their sleep log. Every seven nights, they also complete the Sleep Needs Questionnaire. At the beginning, middle, and end of the study, they complete the Insomnia Severity Inventory in the app. At the end of every week, a sleep schedule and weekly summary are calculated via automated formulas. The app also contains access to messaging a coach, for participants to ask questions about their daily lessons and application of the skills and to feel supported and accountable. The REST device in the Full Sleep program uses radar to passively track sleep patterns and nighttime awakenings. It also offers white noise options and audio guidance for relaxation techniques and stimulus control.<br>|
| Active Comparator: Path to Better Sleep<br>Path to Better Sleep is a self-management tool for insomnia. It is available as a web-based program at https://www.veterantraining.va.gov/apps/insomnia/index.html#dashboard. Path to Better Sleep is intended to be completed over six weeks, and includes weekly educational lessons about sleep which include videos, visual depictions, and interactive activities, in addition to sleep check-ins (e.g., knowledge checks, self reflections about sleep). It also includes sleep logging. Participants in this condition will be asked to share their sleep log weekly via email, as Stanford and Koko Labs do not receive access to the data. | Behavioral: Path to Better Sleep<br>* Path to Better Sleep is a self-management tool for insomnia. It is available as a web-based program at https://www.veterantraining.va.gov/apps/insomnia/index.html#dashboard. Path to Better Sleep is intended to be completed over six weeks, and includes weekly educational lessons about sleep which include videos, visual depictions, and interactive activities, in addition to sleep check-ins (e.g., knowledge checks, self reflections about sleep). It also includes sleep logging. Participants in this condition will be asked to share their sleep log weekly via email, as Stanford and Koko Labs do not receive access to the data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | A measure of insomnia symptoms | Completion of program (6-8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | The proportion of time sleeping while in bed | Completion of program (6-8 weeks) | 
| Wakefulness after sleep onset | # minutes awake after falling asleep | Completion of program (6-8 weeks) | 
| Number of awakenings |  | Completion of program (6-8 weeks) | 
| Sleep onset latency | Minutes to fall asleep | Completion of program (6-8 weeks) | 
| Total sleep time |  | Completion of program (6-8 weeks) |