search
Back to results

Effectiveness and Adherence to an Online Sleep Program

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Go! to Sleep
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insomnia focused on measuring Insomnia, Sleep, Stress, Online program, Web-based program, Cognitive Behavioral Therapy for Insomnia (CBT-i)

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Go! to Sleep

Control Group

Arm Description

Participants access and utilize the 6-week online program that provides a set of various psycho-educational materials and behavioral techniques to treat insomnia.

No intervention provided. These participants will receive the Go! to Sleep program after the research trial has been completed (10 weeks after registration).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2011
Last Updated
May 6, 2022
Sponsor
The Cleveland Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01440777
Brief Title
Effectiveness and Adherence to an Online Sleep Program
Official Title
Effectiveness and Adherence to an Online Sleep Program - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Sleep, Stress, Online program, Web-based program, Cognitive Behavioral Therapy for Insomnia (CBT-i)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Go! to Sleep
Arm Type
Active Comparator
Arm Description
Participants access and utilize the 6-week online program that provides a set of various psycho-educational materials and behavioral techniques to treat insomnia.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention provided. These participants will receive the Go! to Sleep program after the research trial has been completed (10 weeks after registration).
Intervention Type
Behavioral
Intervention Name(s)
Go! to Sleep
Intervention Description
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
Primary Outcome Measure Information:
Title
Insomnia severity
Description
To assess the effectiveness of the online Go! to Sleep program in improving sleep by measuring insomnia severity using the Insomnia Severity Index (ISI).
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Insomnia symptoms
Description
To determine if the program helps improve insomnia symptoms as measured by the Pittsburgh Insomnia Rating Scale (PIRS)
Time Frame
5 months
Title
Sleep pattern
Description
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)
Time Frame
5 months
Title
Daytime Dysfunction
Description
To determine if the program improves daytime dysfunction (Pittsburgh Sleep Quality Index subscale)
Time Frame
5 months
Title
Stress
Description
To assess whether the program reduces stress as measured by the Perceived Stress Scale (PSS10)
Time Frame
5 months
Title
Program adherence
Description
To assess program adherence and its relation to program effectiveness
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Bernstein, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness and Adherence to an Online Sleep Program

We'll reach out to this number within 24 hrs