Effectiveness and Adherence to an Online Sleep Program
This study is currently recruiting participants.
Verified January 2013 by The Cleveland Clinic
Sponsor:
The Cleveland Clinic
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01440777
First received: September 23, 2011
Last updated: January 17, 2013
Last verified: January 2013
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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 2013 |
| Estimated Primary Completion Date: | April 2013 (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:
|
|
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 70 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 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.
- 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 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
Contacts
| Contact: Susan E. Fay | 216-448-8339 | GoToSleepResearch@ccf.org |
| Contact: Gina Gendy, M.D. | GoToSleepResearch@ccf.org |
Locations
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Susan E Fay 216-448-8339 GoToSleepResearch@ccf.org | |
| Contact: Gina Gendy, M.D. GoToSleepResearch@ccf.org | |
| Sub-Investigator: Michelle Drerup, Psy.D | |
| Sub-Investigator: Doug Moul, M.D. | |
| Sub-Investigator: Adam Bernstein, M.D. | |
| Sub-Investigator: Michael Roizen, M.D. | |
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 17, 2013 |
| 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 May 22, 2013