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

NCT03213132 | Completed

• 2 other identifiers: 2017-0089-00R01AG047885
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Sleep Initiation and Maintenance Disorders

Keywords

sleep; insomnia; CBT

Outcome Measures

Primary Outcomes (1)

• Primary Sleep Outcome: Change in overall insomnia severity

  Insomnia Severity Index (ISI)

  Baseline, 9 weeks, 6 months, 1 year

Secondary Outcomes (5)

• Sleep variables: Change in wake after sleep onset (WASO)

  Baseline, 9 weeks, 6 months, 1 year

• Sleep variables: Change in sleep onset latency (SOL)

  Baseline, 9 weeks, 6 months, 1 year

• Daytime variables: change in attention and concentration

  Baseline, 9 weeks, 6 months, 1 year

• Daytime variables: change in levels of fatigue

  Baseline, 9 weeks, 6 months, 1 year

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

  Baseline, 9 weeks, 6 months, 1 year

Study Arms (3)

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.

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.

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.

Behavioral: Patient Education

Interventions

SHUTi (Sleep Health Using the Internet) BEHAVIORAL

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

Also known as: CBTi

SHUTi for older adults; SHUTi for older adults with stepped care

Patient Education BEHAVIORAL

Educational website containing information on insomnia

Also known as: Information

Patient Education website

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• Laval University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (4)

• 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.

  PMID: 27902836 BACKGROUND

• 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.

  PMID: 17162986 BACKGROUND

• 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.

  PMID: 19581560 BACKGROUND

• 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.

  PMID: 37480840 DERIVED

Related Links

• Center for Behavioral Health and Technology at the University of Virginia

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Karen Ingersoll, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Neurobehavoiral Sciences

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 11, 2017
• Study Start: February 13, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)