Effectiveness and Adherence to an Online Sleep Program

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01440777
First received: September 23, 2011
Last updated: January 27, 2014
Last verified: January 2014

September 23, 2011
January 27, 2014
October 2011
April 2014   (final data collection date for primary outcome measure)
Insomnia severity [ Time Frame: 5 months ] [ Designated as safety issue: No ]
To assess the effectiveness of the online Go! to Sleep program in improving sleep by measuring insomnia severity using the Insomnia Severity Index (ISI).
Same as current
Complete list of historical versions of study NCT01440777 on ClinicalTrials.gov Archive Site
  • Insomnia symptoms [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    To determine if the program helps improve insomnia symptoms as measured by the Pittsburgh Insomnia Rating Scale (PIRS)
  • Sleep pattern [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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)
  • Daytime Dysfunction [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    To determine if the program improves daytime dysfunction (Pittsburgh Sleep Quality Index subscale)
  • Stress [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    To assess whether the program reduces stress as measured by the Perceived Stress Scale (PSS10)
  • Program adherence [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    To assess program adherence and its relation to program effectiveness
Same as current
Not Provided
Not Provided
 
Effectiveness and Adherence to an Online Sleep Program
Effectiveness and Adherence to an Online Sleep Program - A Pilot Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Insomnia
Behavioral: Go! to Sleep

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
  • Active Comparator: Go! to Sleep
    Participants access and utilize the 6-week online program that provides a set of various psycho-educational materials and behavioral techniques to treat insomnia.
    Intervention: Behavioral: Go! to Sleep
  • No Intervention: Control Group
    No intervention provided. These participants will receive the Go! to Sleep program after the research trial has been completed (10 weeks after registration).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 89 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01440777
IRB# 11-860
No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Adam Bernstein, M.D. The Cleveland Clinic
The Cleveland Clinic
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP