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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014