Status:
COMPLETED
Effectiveness and Adherence to an Online Sleep Program
Lead Sponsor:
The Cleveland Clinic
Conditions:
Insomnia
Eligibility:
All Genders
18-89 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01440777
Start Date
October 1 2011
End Date
June 1 2014
Last Update
May 11 2022
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195