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InsomniaPhase 3SHUTiNCT01438697

An Interactive Internet Intervention for Adults With Insomnia

A Phase 3 study testing Internet Intervention and Patient Education Website in people with Insomnia and Sleep Initiation and Maintenance Disorders, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 years
What is being tested?
Internet Intervention and Patient Education Website
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
1 siteUnited States
Study dates
Oct 2011to Oct 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Internet Intervention, Patient Education Website
Keywords
sleep, insomnia, internet, CBT
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet InterventionBehavioural

    Also called Sleep Healthy Using the Internet (SHUTi)

    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.

  • Patient Education WebsiteBehavioural

    Participants will be given access to a relevant patient education website. It will contain material addressing the behaviors and symptoms of insomnia.

Study groups in NCT01438697
Study groupRoleWhat they receive
Internet InterventionExperimentalAssigned to Sleep Healthy Using the Internet (SHUTi)
Receives: Behavioral: Internet Intervention
Patient Education WebsiteActive comparatorAssigned to Patient Insomnia Educational Website
Receives: Behavioral: Patient Education Website

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary sleep symptoms: sleep onset latency (SOL), wake after sleep onset (WASO), insomnia severity (ISI)

    Measured: Baseline, 9 weeks, 6 months, 1 year

Secondary outcomes (6)

  1. Secondary sleep symptoms: sleep efficiency (SE), number of night time awakenings, sleep quality, total sleep time (TST)

    Measured: Baseline, 9 weeks, 6 months, 1 year

  2. Psychological distress: levels of depression, levels of anxiety, sleep-related cognitions

    Measured: Baseline, 9 weeks, 6 months, 1 year

  3. Health symptoms: fatigue, quality of life

    Measured: Baseline, 9 weeks, 6 months, 1 year

  4. Cost effectiveness: program delivery cost, participant resource utilization and costs, quality adjusted life years (QALYs)

    Measured: 9 weeks, 6 months, 1 year

  5. Intervention Evaluation: perceived utility, perceived impact, intervention adherence, intervention use

    Measured: 9 weeks, 6 months, 1 year

  6. Exploratory Outcome Measures: health care access, coverage and utilization

    Measured: Baseline, 9 weeks, 6 months, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01438697
Sponsor's protocol ID
15704
Other IDs
1R01MH086758-01A1
Acronym
SHUTi
Status last verified
Jan 2017
First submitted
20 Sep 2011
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 24014057

  • 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.

    PubMed 26994361

  • 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.

    PubMed 27902836

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Internet Intervention and Patient Education Website in people with Insomnia and Sleep Initiation and Maintenance Disorders, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary sleep symptoms: sleep onset latency (SOL), wake after sleep onset (WASO), insomnia severity (ISI) (time frame: Baseline, 9 weeks, 6 months, 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01438697, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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