University of Virginia Health System, Behavioral Health and Technology
Charlottesville, Virginia, 22903, United States
NCT Number: NCT00328250
This study will evaluate the effectiveness of an online cognitive behavioral therapy intervention in improving sleep, mood, and cognitive functioning in people with insomnia.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
Charlottesville, Virginia, 22903, United States
Insomnia is a disorder that is characterized by a perception or complaint of inadequate or poor-quality sleep. Symptoms of insomnia include difficulty falling asleep, waking frequently during the night and having difficulty returning to sleep, waking too early in the morning, and unrefreshing sleep. Insomnia may also cause problems during the day, such as tiredness, difficulty concentrating, and irritability. Cognitive behavior therapy (CBT) has been found to have significant short- and long-term benefits for people with insomnia. Access to CBT for many people, however, is limited, due to the high cost of treatment and a lack of trained professionals in some locations. Delivering CBT via the internet could help make the treatment more widely available. This study will evaluate the effectiveness of an online CBT intervention in improving sleep, mood, and cognitive functioning in people with insomnia.
Participants in this open label study will be randomly assigned to receive the online CBT intervention either immediately or after a 4-month waiting period. Participants will use the online program for 1 to 2 hours per week for 8 weeks. Participants will keep track of their sleep patterns for the first and last 2 weeks of a 4-month period by keeping a daily diary and wearing a wrist watch device that monitors movement. All participants will report to the study site for baseline evaluations before beginning treatment and for final evaluations upon completing the program, about 4 months after study entry.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CBT delivered over the Internet for insomnia targets maladaptive behaviors and dysfunctional thoughts that perpetuate sleep problems. Treatment includes through educational, behavioral, and cognitive strategies.
Time frame: Measured at baseline and Months 3 and 9
Time frame: Measured at baseline and Months 3 and 9
Time frame: Measured at baseline and Month 3
Time frame: Measured at baseline and Month 3
Time frame: Measured at baseline and Month 3
Time frame: Measured at baseline and Month 3
Time frame: Measured at baseline and Month 3
Time frame: Measured at baseline and Month 3
Time frame: Measured at baseline and Months 3 and 9
Time frame: Measured at baseline and Month 3
Time frame: Measured at Month 3
University of Virginia
Other
Internet Insomnia Intervention: Development and Feasibility
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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