View Clinical Trial (Medical Research Study)
Effectiveness and Adherence to an Online Sleep Program - A Pilot Study
| City: |
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Cleveland |
| State: |
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Ohio |
| Zip Code: |
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44195 |
| Conditions: |
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Insomnia |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01440777 |
| Primary Contact: |
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Principal Investigator
Adam Bernstein, M.D.
The Cleveland Clinic
Susan E. Fay
Phone: 216-448-8339
Email: GoToSleepResearch@ccf.org
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| Backup Contact: |
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Email: GoToSleepResearch@ccf.org
Gina Gendy, M.D.
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| Location Contact: |
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Cleveland, Ohio 44195
United States
Susan E Fay
Phone: 216-448-8339
Email: GoToSleepResearch@ccf.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
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