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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH086758-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet Intervention | Experimental | Assigned to Sleep Healthy Using the Internet (SHUTi) |
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| Patient Education Website | Active Comparator | Assigned to Patient Insomnia Educational Website |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary sleep symptoms: sleep onset latency (SOL), wake after sleep onset (WASO), insomnia severity (ISI) | Baseline, 9 weeks, 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary sleep symptoms: sleep efficiency (SE), number of night time awakenings, sleep quality, total sleep time (TST) | Baseline, 9 weeks, 6 months, 1 year | |
| Psychological distress: levels of depression, levels of anxiety, sleep-related cognitions | Baseline, 9 weeks, 6 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Ingersoll, PhD | University Of Virginia Behavioral Health & Technology | Principal Investigator |
| Lee M Ritterband, PhD | University of Virginia Behavioral Health & Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Division of Behavioral Health and Technology | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24014057 | Result | Thorndike FP, Ritterband LM, Gonder-Frederick LA, Lord HR, Ingersoll KS, Morin CM. A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms. J Clin Psychol. 2013 Oct;69(10):1078-93. doi: 10.1002/jclp.22032. Epub 2013 Aug 28. | |
| 26994361 | Result | Quigg M, Gharai S, Ruland J, Schroeder C, Hodges M, Ingersoll KS, Thorndike FP, Yan G, Ritterband LM. Insomnia in epilepsy is associated with continuing seizures and worse quality of life. Epilepsy Res. 2016 May;122:91-6. doi: 10.1016/j.eplepsyres.2016.02.014. Epub 2016 Mar 2. |
| Label | URL |
|---|---|
| Sleep Health Using the Internet intervention site | View source |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Patient Education Website | Behavioral | Participants will be given access to a relevant patient education website. It will contain material addressing the behaviors and symptoms of insomnia. |
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| Health symptoms: fatigue, quality of life | Baseline, 9 weeks, 6 months, 1 year |
| Cost effectiveness: program delivery cost, participant resource utilization and costs, quality adjusted life years (QALYs) | 9 weeks, 6 months, 1 year |
| Intervention Evaluation: perceived utility, perceived impact, intervention adherence, intervention use | 9 weeks, 6 months, 1 year |
| Exploratory Outcome Measures: health care access, coverage and utilization | Baseline, 9 weeks, 6 months, 1 year |
| 27902836 | Result | Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):68-75. doi: 10.1001/jamapsychiatry.2016.3249. |
| University of Virginia Behavioral Health \& Technology research lab | View source |
| D001523 |
| Mental Disorders |