An Interactive Internet Intervention for Adults With Insomnia (SHUTi)

January 11, 2017 updated by: Karen Ingersoll, University of Virginia

An Internet Intervention for Insomnia: Efficacy and Dissemination

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

303

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University Of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Division of Behavioral Health and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Baseline, 9 weeks, 6 months, 1 year
Health symptoms: fatigue, quality of life
Time Frame: Baseline, 9 weeks, 6 months, 1 year
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
9 weeks, 6 months, 1 year
Intervention Evaluation: perceived utility, perceived impact, intervention adherence, intervention use
Time Frame: 9 weeks, 6 months, 1 year
9 weeks, 6 months, 1 year
Exploratory Outcome Measures: health care access, coverage and utilization
Time Frame: Baseline, 9 weeks, 6 months, 1 year
Baseline, 9 weeks, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Karen Ingersoll, PhD, University of Virginia Behavioral Health & Technology
  • Study Director: Lee M Ritterband, PhD, University of Virginia Behavioral Health & Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15704
  • 1R01MH086758-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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