Clinical trial NCT03213132: Sleep Healthy Using The Internet for Older Adult Sufferers of Insomnia and Sleeplessness
Official title: An Insomnia Internet Intervention for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep Initiation and Maintenance Disorders
Keywords: sleep
insomnia
CBT
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Laval University
name: National Institute on Aging (NIA)
First posted: 2017-07-11
Enrollment: 311
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary Sleep Outcome: Change in overall insomnia severity
timeFrame: Baseline, 9 weeks, 6 months, 1 year
Secondary outcomes:
measure: Sleep variables: Change in wake after sleep onset (WASO)
timeFrame: Baseline, 9 weeks, 6 months, 1 year
measure: Sleep variables: Change in sleep onset latency (SOL)
timeFrame: Baseline, 9 weeks, 6 months, 1 year
measure: Daytime variables: change in attention and concentration
timeFrame: Baseline, 9 weeks, 6 months, 1 year
measure: Daytime variables: change in levels of fatigue
timeFrame: Baseline, 9 weeks, 6 months, 1 year
measure: Daytime variables: change in mood (levels of depression and anxiety)
timeFrame: Baseline, 9 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Karen Ingersoll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.