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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Karen Ingersoll, University of Virginia

Tracking Information
First Submitted Date  ICMJE September 20, 2011
First Posted Date  ICMJE September 22, 2011
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
Primary sleep symptoms: sleep onset latency (SOL), wake after sleep onset (WASO), insomnia severity (ISI) [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
  • 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 ]
  • Psychological distress: levels of depression, levels of anxiety, sleep-related cognitions [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ]
  • Health symptoms: fatigue, quality of life [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ]
  • Cost effectiveness: program delivery cost, participant resource utilization and costs, quality adjusted life years (QALYs) [ Time Frame: 9 weeks, 6 months, 1 year ]
  • Intervention Evaluation: perceived utility, perceived impact, intervention adherence, intervention use [ Time Frame: 9 weeks, 6 months, 1 year ]
  • Exploratory Outcome Measures: health care access, coverage and utilization [ Time Frame: Baseline, 9 weeks, 6 months, 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Interactive Internet Intervention for Adults With Insomnia
Official Title  ICMJE An Internet Intervention for Insomnia: Efficacy and Dissemination
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Intervention  ICMJE
  • 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)
  • 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.
Study Arms  ICMJE
  • Experimental: Internet Intervention
    Assigned to Sleep Healthy Using the Internet (SHUTi)
    Intervention: Behavioral: Internet Intervention
  • Active Comparator: Patient Education Website
    Assigned to Patient Insomnia Educational Website
    Intervention: Behavioral: Patient Education Website
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2016)
303
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2011)
300
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01438697
Other Study ID Numbers  ICMJE 15704
1R01MH086758-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karen Ingersoll, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Karen Ingersoll, PhD University Of Virginia Behavioral Health & Technology
Study Director: Lee M Ritterband, PhD University of Virginia Behavioral Health & Technology
PRS Account University of Virginia
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP