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.
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
- Conditions the study is for
- Insomnia, Sleep Initiation and Maintenance Disorders
- What is being tested?
- SHUTi (Sleep Health Using the Internet) and Patient Education
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| SHUTi for older adults | Experimental | Participants 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 care | Active comparator | Participants 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 website | Placebo comparator | Participants 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.
Primary Sleep Outcome: Change in overall insomnia severity
Insomnia Severity Index (ISI)
Measured: Baseline, 9 weeks, 6 months, 1 year
Secondary outcomes (5)
Sleep variables: Change in wake after sleep onset (WASO)
Consensus sleep diary questions
Measured: Baseline, 9 weeks, 6 months, 1 year
Sleep variables: Change in sleep onset latency (SOL)
Consensus sleep diary questions
Measured: Baseline, 9 weeks, 6 months, 1 year
Daytime variables: change in attention and concentration
Multiple Ability Self-Report Questionnaire
Measured: Baseline, 9 weeks, 6 months, 1 year
Daytime variables: change in levels of fatigue
Fatigue Symptom Inventory
Measured: Baseline, 9 weeks, 6 months, 1 year
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.
- First posted11 Jul 2017
- Study start13 Feb 2018
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Karen Ingersoll, University of Virginia
- Investigators
- Karen Ingersoll, PhD, Principal investigator, University of Virginia
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 27902836Morin 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 17162986Ritterband 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 19581560Shaffer 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 41883997Shaffer 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Insomnia Internet Intervention for Older Adults
- ClinicalTrials.gov ID
- NCT03213132
- Acronym / sponsor ID
- SHUTiOASIS / 2017-0089-00
- Keywords
- sleep, insomnia, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Laval University, National Institute on Aging (NIA)
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHUTi for older adults | Experimental | Behavioral: SHUTi (Sleep Health Using the Internet)Participants 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. |
| SHUTi for older adults with stepped care | Active comparator | Behavioral: SHUTi (Sleep Health Using the Internet)Participants 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. |
| Patient Education website | Placebo comparator | Behavioral: Patient EducationParticipants 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHUTi (Sleep Health Using the Internet)Also: CBTiCognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program | Behavioural | SHUTi for older adults, SHUTi for older adults with stepped care |
| Patient EducationAlso: InformationEducational website containing information on insomnia | Behavioural | Patient Education website |
Primary outcome
Primary Sleep Outcome: Change in overall insomnia severity
Time frame: Baseline, 9 weeks, 6 months, 1 year
Insomnia Severity Index (ISI)
5 secondary outcomes
Sleep variables: Change in wake after sleep onset (WASO)
Time frame: Baseline, 9 weeks, 6 months, 1 year
Sleep variables: Change in sleep onset latency (SOL)
Time frame: Baseline, 9 weeks, 6 months, 1 year
Daytime variables: change in attention and concentration
Time frame: Baseline, 9 weeks, 6 months, 1 year
Daytime variables: change in levels of fatigue
Time frame: Baseline, 9 weeks, 6 months, 1 year
Daytime variables: change in mood (levels of depression and anxiety)
Time frame: Baseline, 9 weeks, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Background: PubMed 27902836Ritterband 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.
- Background: PubMed 17162986Morin 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.
- Background: PubMed 19581560Ritterband 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.
- Derived from this study: PubMed 41883997Shaffer 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.
- Derived from this study: PubMed 37480840Shaffer 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.
- Center for Behavioral Health and Technology at the University of VirginiaLink provided by the sponsor.
- SHUTi OASIS Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Ingersoll, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
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.