Effectiveness and Adherence to an Online Sleep Program

Not Applicable

Completed

• Conditions: Insomnia

• Registration Number: NCT01440777
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-27
• Study Start: 2011-10
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia severity	5 months	To assess the effectiveness of the online Go! to Sleep program in improving sleep by measuring insomnia severity using the Insomnia Severity Index (ISI).

Secondary Outcome Measures

Name	Time	Method
Daytime Dysfunction	5 months	To determine if the program improves daytime dysfunction (Pittsburgh Sleep Quality Index subscale)
Sleep pattern	5 months	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)
Program adherence	5 months	To assess program adherence and its relation to program effectiveness
Insomnia symptoms	5 months	To determine if the program helps improve insomnia symptoms as measured by the Pittsburgh Insomnia Rating Scale (PIRS)
Stress	5 months	To assess whether the program reduces stress as measured by the Perceived Stress Scale (PSS10)

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States