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An Interactive Internet Intervention for Adults With Insomnia (SHUTi)

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ClinicalTrials.gov Identifier: NCT01438697
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : January 12, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Karen Ingersoll, University of Virginia

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

Condition or disease Intervention/treatment Phase
Insomnia Sleep Initiation and Maintenance Disorders Behavioral: Internet Intervention Behavioral: Patient Education Website Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Internet Intervention for Insomnia: Efficacy and Dissemination
Study Start Date : October 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Internet Intervention
Assigned to Sleep Healthy Using the Internet (SHUTi)
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.
Other Name: Sleep Healthy Using the Internet (SHUTi)

Active Comparator: Patient Education Website
Assigned to Patient Insomnia Educational Website
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.

Primary Outcome Measures :
  1. Primary sleep symptoms: sleep onset latency (SOL), wake after sleep onset (WASO), insomnia severity (ISI) [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ]

Secondary Outcome Measures :
  1. Secondary sleep symptoms: sleep efficiency (SE), number of night time awakenings, sleep quality, total sleep time (TST) [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ]
  2. Psychological distress: levels of depression, levels of anxiety, sleep-related cognitions [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ]
  3. Health symptoms: fatigue, quality of life [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ]
  4. Cost effectiveness: program delivery cost, participant resource utilization and costs, quality adjusted life years (QALYs) [ Time Frame: 9 weeks, 6 months, 1 year ]
  5. Intervention Evaluation: perceived utility, perceived impact, intervention adherence, intervention use [ Time Frame: 9 weeks, 6 months, 1 year ]
  6. Exploratory Outcome Measures: health care access, coverage and utilization [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438697

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United States, Virginia
University Of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Division of Behavioral Health and Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
National Institute of Mental Health (NIMH)
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Principal Investigator: Karen Ingersoll, PhD University Of Virginia Behavioral Health & Technology
Study Director: Lee M Ritterband, PhD University of Virginia Behavioral Health & Technology
Additional Information:
Publications of Results:
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Responsible Party: Karen Ingersoll, Associate Professor, Department of Psychiatry and NB Sciences, University of Virginia
ClinicalTrials.gov Identifier: NCT01438697    
Other Study ID Numbers: 15704
1R01MH086758-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Karen Ingersoll, University of Virginia:
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders