Status:
COMPLETED
An Interactive Internet Intervention for Adults With Insomnia
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Insomnia
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
21-65 years
Phase:
PHASE3
Brief Summary
This study will compare the efficacy of an interactive Internet intervention for adult insomnia (Sleep Healthy Using the Internet; SHUTi) to that of a static educational website to improve sleep, mood...
Detailed Description
Insomnia is defined by complaints of poor sleep, as well as difficulties initiating and/or maintaining sleep more than 3 nights/week for more than 6 months. Insomnia may contribute to daytime fatigue,...
Eligibility Criteria
Inclusion
- Age between 21 and 65 years old.
- Have sleep-onset insomnia and/or sleep maintenance insomnia (\>30 minutes for at least 3 nights/week).
- Have insomnia symptoms lasting at least 6 months.
- Have an average total sleep time ≤ 6.5 hours.
- Sleep disturbances (or associated daytime fatigue) cause significant distress or impairment in social, occupational, or other areas of functioning.
- Have regular access to a computer and the Internet.
- Reside in the United States or are US Citizens living outside the United States
Exclusion
- Pregnancy
- Report of a physical illness which is deemed active, unstable, degenerative, and/or progressive, such as congestive heart failure, dementia, or acute pain.
- Bipolar disorder as defined by a manic or hypomanic episode or treatment within the past 10 years.
- Severe depression.
- Endorse risk of suicide.
- Endorse alcohol or drug abuse within the past year.
- Presence of another untreated sleep disorder (e.g., sleep apnea, periodic leg movements).
- Have irregular sleep schedules, with usual bedtimes earlier than 8:00pm or later than 2:00am or arising times earlier than 4:00am or later than 10:00am.
- Current psychological treatment for insomnia.
- Initiating psychological treatment within past 3 months.
- Unstable medication regimen (change to schedule or dosage within past 3 months) for a medication regimen thought to impact sleep.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT01438697
Start Date
October 1 2011
End Date
October 1 2014
Last Update
January 12 2017
Active Locations (1)
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1
University Of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Division of Behavioral Health and Technology
Charlottesville, Virginia, United States, 22903