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
  Purpose

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.


Condition Intervention
Insomnia
Behavioral: Go! to Sleep

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effectiveness and Adherence to an Online Sleep Program - A Pilot Study

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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).

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440777

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Adam Bernstein, M.D. The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01440777     History of Changes
Other Study ID Numbers: IRB# 11-860
Study First Received: September 23, 2011
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Insomnia
Sleep
Stress
Online program
Web-based program
Cognitive Behavioral Therapy for Insomnia (CBT-i)

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014