NCT01438697

An Interactive Internet Intervention for Adults With Insomnia

An Internet Intervention for Insomnia: Efficacy and Dissemination

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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 related symptoms, perceived health status, and overall quality of life.

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, impaired performance, confused thinking and judgment, and difficulty with work and personal tasks. Cognitive behavioral 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 limited number of trained professionals. Delivering CBT for insomnia via the Internet could help make it more widely available. This study will compare the effectiveness of an online CBT intervention in improving sleep, mood, and quality of life in people with insomnia to that of a static educational website. Participants in this study will be randomly assigned to receive the online CBT intervention or the static patient education website. The intervention period will last for 9 weeks. During the intervention period, participants assigned to the patient education website will be given content addressing strategies for dealing with insomnia. Those assigned to use the Internet intervention will review interactive, tailored content specific to the user's difficulties. Participants will complete questionnaires and two weeks of daily sleep diaries about their symptoms at four time points - at the beginning of the study, immediately after completing the 9 week program, 6 months later, and 12 months later.

Conditions

• Insomnia
• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Internet Intervention	Participants will spend 1-2 hours each week for 9 weeks using the Internet intervention. Users will complete daily sleep diaries as well as interactive tutorials covering the topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progress through the program they will receive tailored instructions for how to improve their sleep.
BEHAVIORAL	Patient Education Website	Participants will be given access to a relevant patient education website. It will contain material addressing the behaviors and symptoms of insomnia.

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-09-22
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States