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

Primary Purpose

Insomnia, Sleep Initiation and Maintenance Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHUTi (Sleep Health Using the Internet)
Patient Education
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring sleep, insomnia, CBT

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

SHUTi for older adults

SHUTi for older adults with stepped care

Patient Education website

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Primary Sleep Outcome: Change in overall insomnia severity
Insomnia Severity Index (ISI)

Secondary Outcome Measures

Sleep variables: Change in wake after sleep onset (WASO)
Consensus sleep diary questions
Sleep variables: Change in sleep onset latency (SOL)
Consensus sleep diary questions
Daytime variables: change in attention and concentration
Multiple Ability Self-Report Questionnaire
Daytime variables: change in levels of fatigue
Fatigue Symptom Inventory
Daytime variables: change in mood (levels of depression and anxiety)
Hospital Anxiety and Depression Scale

Full Information

First Posted
July 3, 2017
Last Updated
April 28, 2021
Sponsor
University of Virginia
Collaborators
Laval University, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03213132
Brief Title
Sleep Healthy Using The Internet for Older Adult Sufferers of Insomnia and Sleeplessness
Acronym
SHUTiOASIS
Official Title
An Insomnia Internet Intervention for Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Laval University, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Initiation and Maintenance Disorders
Keywords
sleep, insomnia, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHUTi for older adults
Arm Type
Experimental
Arm Description
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.
Arm Title
SHUTi for older adults with stepped care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patient Education website
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SHUTi (Sleep Health Using the Internet)
Other Intervention Name(s)
CBTi
Intervention Description
Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
Intervention Type
Behavioral
Intervention Name(s)
Patient Education
Other Intervention Name(s)
Information
Intervention Description
Educational website containing information on insomnia
Primary Outcome Measure Information:
Title
Primary Sleep Outcome: Change in overall insomnia severity
Description
Insomnia Severity Index (ISI)
Time Frame
Baseline, 9 weeks, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Sleep variables: Change in wake after sleep onset (WASO)
Description
Consensus sleep diary questions
Time Frame
Baseline, 9 weeks, 6 months, 1 year
Title
Sleep variables: Change in sleep onset latency (SOL)
Description
Consensus sleep diary questions
Time Frame
Baseline, 9 weeks, 6 months, 1 year
Title
Daytime variables: change in attention and concentration
Description
Multiple Ability Self-Report Questionnaire
Time Frame
Baseline, 9 weeks, 6 months, 1 year
Title
Daytime variables: change in levels of fatigue
Description
Fatigue Symptom Inventory
Time Frame
Baseline, 9 weeks, 6 months, 1 year
Title
Daytime variables: change in mood (levels of depression and anxiety)
Description
Hospital Anxiety and Depression Scale
Time Frame
Baseline, 9 weeks, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Ingersoll, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27902836
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.
Results Reference
background
PubMed Identifier
17162986
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.
Results Reference
background
PubMed Identifier
19581560
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. Erratum In: Arch Gen Psychiatry. 2010 Mar;67(3):311.
Results Reference
background
Links:
URL
http://bht.virginia.edu
Description
Center for Behavioral Health and Technology at the University of Virginia
URL
http://shutioasis.org
Description
SHUTi OASIS Study Website

Learn more about this trial

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

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