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InsomniaSHUTiOASISNCT03213132

Sleep Healthy Using The Internet for Older Adult Sufferers of Insomnia and Sleeplessness

A study testing SHUTi (Sleep Health Using the Internet) and Patient Education 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 older adults with insomnia called SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness) accessed at www.shutioasis.org both with and without support for adherence to that of a static… Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
What is being tested?
SHUTi (Sleep Health Using the Internet) and Patient Education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
311 participants
Where
1 siteUnited States
Study dates
13 Feb 2018to 1 Nov 2020
Phase
Interventional
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 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age 55 and over
  • sleep onset latency (SOL) and/or wake after sleep onset (WASO) (>30 minutes for at least 3 nights/week)
  • insomnia symptoms for ≥ 3 months
  • no more than 6.5 hours of sleep per night
  • the sleep disturbance (or associated daytime fatigue) must cause significant distress or - impairment in social, occupational, or other areas of functioning
  • regular access (at least 2/week) and willingness to use a computer and the Internet and check email
  • ability to read and speak English
  • resident of the US

Who cannot join

  • irregular sleep schedules that prevent the ability to follow intervention recommendations(i.e., with usual bedtimes outside of 8:00pm to 2:00am or arising time outside of 4:00am to 10:00am)
  • current psychological treatment for insomnia
  • initiated psychological or psychiatric treatment within past 3 months
  • screen positive for a history of psychotic or bipolar disorder; and current severe depression, high risk of suicide, substance use (alcohol, drug) disorder within the past year
  • symptoms suggestive of untreated sleep disorders other than insomnia (e.g., obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder)
  • presence of severe cognitive impairment
  • presence of uncontrolled medical condition that is deemed to interfere with the study procedures, or put the study participant at undue risk

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Virginia

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

Official title: An Insomnia Internet Intervention for Older Adults

This study will compare the efficacy of an interactive internet intervention for older adults with insomnia called SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness) accessed at www.shutioasis.org both with and without support for adherence to that of a static educational website to improve sleep, health, mood, and overall quality of life.

Read the detailed description

Insomnia is a significant public health problem for older adults with substantial medical, psychological and financial ramifications. With as many as 20-30% of older adults (age ≥55) meeting diagnostic criteria for chronic insomnia, finding accessible, effective, and low-cost treatments is critical. Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a non-pharmacological intervention that has been shown to be efficacious when tailored for older adults. Regrettably, access to this treatment is significantly limited by a lack of trained clinicians and expense. To overcome barriers to face-to-face care, use of the Internet has emerged as a feasible and effective method to provide health information and treatment. Unfortunately, the health care field has been reluctant to use technology-delivered solutions with older patients out of a concern that older adults either do not have access to or do not want to use technology. However, older adults in the U.S. are the largest growing group of Internet users, and they generally have a desire to learn new technologies. When older adults do use technology-based programs for health promotion, they rate these programs favorably. Internet-delivered CBT-I for older adults has a high likelihood of major public health impact by allowing widespread access to a needed intervention, increasing the convenience of obtaining care, and decreasing treatment costs among an age group with high rates of insomnia known to exacerbate other concerns (health, mood, cognition).

The SHUTi Program: SHUTi is a self-guided (i.e., automated), interactive, and tailored web-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention). Intervention content is metered out over time through 6 "Cores." Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). This schedule is consistent with the recommendation from a task force commissioned by the Academy of Sleep Medicine, which deemed that an average of 6 - 8 sessions constitutes "adequate treatment exposure". The SHUTi program relies on user-entered online Sleep Diaries to track progress and to tailor treatment recommendations (i.e., assign a "sleep restriction" window). Each Core acts as an online analog for the weekly sessions typically used when delivering CBT-I in a face-to-face format, following the same general structure: 1) Core objectives (what will be learned and why this information is important), 2) review of previous week's homework and sleep diary data, 3) new intervention material, 4) assignment of homework (treatment strategies for the coming week), and 5) a summary of the Core's main points. Intervention content is enhanced through a variety of interactive features, including personalized goal-setting, graphical feedback based on inputted symptoms, animations / illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Automated emails are also sent to encourage program adherence.

Participants in this study will be randomly assigned for a period of 9 weeks to one of three conditions: (1) the online CBT-i intervention optimized for older adults (SHUTi), (2) the online CBT-i intervention optimized for older adults (SHUTi) with additional adherence and technical support provided (stepped care), or (3) the patient education website. All participants will complete questionnaires and two weeks of daily sleep diaries about their symptoms at four time points - at the beginning of the study (baseline), immediately after completing the 9 week intervention (post), and at 6 and 12 months later.

Being tested
SHUTi (Sleep Health Using the Internet), Patient Education
Keywords
sleep, insomnia, 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.

  • SHUTi (Sleep Health Using the Internet)Behavioural

    Also called CBTi

    Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program

  • Patient EducationBehavioural

    Also called Information

    Educational website containing information on insomnia

Study groups in NCT03213132
Study groupRoleWhat they receive
SHUTi for older adultsExperimentalParticipants will be assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention optimized for older adults. They will spend 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention targeting issues specific to older adults. As users progress through the intervention, they will receive automated, tailored instructions for how to improve their sleep.
Receives: Behavioral: SHUTi (Sleep Health Using the Internet)
SHUTi for older adults with stepped careActive comparatorParticipants will be assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention optimized for older adults. This is the same intervention as the first arm but with the addition of personalized emails or phone calls to participants by study personnel at specific time points as a result of not completing assigned tasks.
Receives: Behavioral: SHUTi (Sleep Health Using the Internet)
Patient Education websitePlacebo comparatorParticipants will be assigned to a relevant patient education website. It will include information about insomnia symptoms, diagnosis, prognosis, and information about CBT strategies for the older adult. Unlike SHUTi, the content will not be tailored and will be presented all at once.
Receives: Behavioral: Patient Education

What is being measured

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

  1. Primary Sleep Outcome: Change in overall insomnia severity

    Insomnia Severity Index (ISI)

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

Secondary outcomes (5)
  1. Sleep variables: Change in wake after sleep onset (WASO)

    Consensus sleep diary questions

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

  2. Sleep variables: Change in sleep onset latency (SOL)

    Consensus sleep diary questions

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

  3. Daytime variables: change in attention and concentration

    Multiple Ability Self-Report Questionnaire

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

  4. Daytime variables: change in levels of fatigue

    Fatigue Symptom Inventory

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

  5. Daytime variables: change in mood (levels of depression and anxiety)

    Hospital Anxiety and Depression Scale

    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 posted11 Jul 2017
  2. Study start13 Feb 2018
  3. Primary completion1 Nov 2020
  4. Study completion1 Nov 2020

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
311 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03213132
Sponsor's protocol ID
2017-0089-00
Other IDs
R01AG047885
Acronym
SHUTiOASIS
Status last verified
Apr 2021
First submitted
3 Jul 2017
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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
  • Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004). Sleep. 2006 Nov;29(11):1398-414. doi: 10.1093/sleep/29.11.1398.

    PubMed 17162986
  • Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66.

    PubMed 19581560
  • Shaffer KM, Daniel KE, Chow PI, Ingersoll K, Ritterband LM. Influence of stepped support on older adults' internet insomnia intervention engagement and outcomes. Internet Interv. 2026 Mar 11;44:100932. doi: 10.1016/j.invent.2026.100932. eCollection 2026 Jun.

    PubMed 41883997
  • Shaffer KM, Daniel KE, Frederick C, Buysse DJ, Morin CM, Ritterband LM. Online sleep diaries: considerations for system development and recommendations for data management. Sleep. 2023 Oct 11;46(10):zsad199. doi: 10.1093/sleep/zsad199.

    PubMed 37480840

Questions about this trial

What is this clinical trial studying?

A study testing SHUTi (Sleep Health Using the Internet) and Patient Education 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 8 inclusion and 7 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 29 Apr 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Outcome: Change in overall insomnia severity (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 NCT03213132, which also lists 5 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 29 Apr 2021.

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