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



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:55 - Any
Updated:2/17/2018
Start Date:February 13, 2018
End Date:December 30, 2021
Contact:Karen Ingersoll, PhD
Email:kes7a@virginia.edu
Phone:434-982-5960

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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 (Sleep Healthy Using the Internet) both with and without support
for adherence to that of a static educational website to improve sleep, health, mood, and
overall quality of life.

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"(Morin et al.,2006). 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.

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 ≥ 6 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
We found this trial at
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Charlottesville, Virginia 22903
(434) 924-0311
Phone: 434-982-5960
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