Effectiveness and Adherence to an Online Sleep Program

Study Overview
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Brief Summary
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This research will examine the effectiveness of a 6-week online sleep program (Go! To Sleep) which provides a set of various psycho-educational materials and behavioral techniques to reduce insomnia symptoms, improve sleep, and improve quality of life.

Official Title
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Effectiveness and Adherence to an Online Sleep Program - A Pilot Study

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Go! to Sleep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 70 years old. Currently living in the continental United States and Canada. Symptoms of insomnia based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) definition of insomnia disorder: Self-reported sleep difficulties (including sleep-onset latency, waking after sleep onset, early waking of more than 30 min duration) 3 or more times a week in the past 3 months. Self-reported insomnia problem for more than 3 months. Self-reported significant daytime impairment due to sleep difficulties. Willingness to log onto the internet on a regular basis for the duration of the study (3-7 months). Willingness and able to complete almost daily a sleep log to track sleep pattern for up to 2 months at a time (approximately 2-3 min daily). Willingness to be in the Wait-list control group and not have access to the program for 3 months. Exclusion Criteria: Pregnant or planning to be pregnant in the next 6 months. Lack of internet access and/or Mac computer at place of residence. Currently participating or have participated in group or individual therapy for insomnia in the prior month. Patient Health Questionnaire (PHQ9) depression score >14. Recent treatment (less than 3 months) or medication for depression or anxiety. Change in treatment or medication for depression or anxiety in the past month or planned change in the next 3 months. Current treatment (therapy, prescription) for any other psychological or emotional conditions (including but not limited to: mania, manic-depression, psychosis, schizophrenia, adjustment disorder). Diagnosed and currently suffering from a sleep disorder (including, but not limited to sleep apnea, restless leg syndrome, sleep walking, narcolepsy) which is untreated or has been treated for less than a month. Suffer from physical symptoms or medical conditions that may affect sleep (including but not limited to: pain, arthritis, tinnitus, diabetes, night time cough, shortness of breath, hot flashes, frequent urination, heartburn). Steroid an stimulant use (including but not limited to prednisone, methylprednisolone or Solumedrol (for inflammatory disorders), methylphenidate, or Ritalin (for Attention-Deficit Hyperactivity disorder), Provigil (for narcolepsy), Wellbutrin or Zyban (for tobacco cessation), cocaine or methylenedioxymethamphetamine (MDMA) (a.k.a. Ecstasy)). Irregular workshift. Having young children who may affect sleep pattern. Taking over-the-counter or prescribed sleep medication 3 or more times a week. Alcoholism. Inability to access the internet on a consistent regular basis for the duration of the study (3-7 months). Inability to complete daily sleep log to track sleep patterns for up to 2 months at a time. Unwillingness to be assigned to the wait-list control group for 3 months prior to gaining access to the program.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Go! to Sleep<br>Participants access and utilize the 6-week online program that provides a set of various psycho-educational materials and behavioral techniques to treat insomnia. | Behavioral: Go! to Sleep<br>* The online program provides various tools for the delivery of the intervention including: Daily articles Daily activities to help get the sleep you need Daily sleep improvement recommendations Audio recorded relaxation exercises Daily e-mails from your program coach Personal progress charts An online sleep log and daily sleep score<br>|
| No Intervention: Control Group<br>No intervention provided. These participants will receive the Go! to Sleep program after the research trial has been completed (10 weeks after registration). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity | To assess the effectiveness of the online Go! to Sleep program in improving sleep by measuring insomnia severity using the Insomnia Severity Index (ISI). | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia symptoms | To determine if the program helps improve insomnia symptoms as measured by the Pittsburgh Insomnia Rating Scale (PIRS) | 5 months | 
| Sleep pattern | To determine if the program helps improve sleep-onset latency (SOL), total sleep time (TST), waking after sleep onset (WASO) (within Go To Sleep! group analysis only) | 5 months | 
| Daytime Dysfunction | To determine if the program improves daytime dysfunction (Pittsburgh Sleep Quality Index subscale) | 5 months | 
| Stress | To assess whether the program reduces stress as measured by the Perceived Stress Scale (PSS10) | 5 months | 
| Program adherence | To assess program adherence and its relation to program effectiveness | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Sleep, Stress, Online program, Web-based program, Cognitive Behavioral Therapy for Insomnia (CBT-i)