NCT01438697

Brief Summary

This study will compare the efficacy of an interactive Internet intervention for adult insomnia (Sleep Healthy Using the Internet; SHUTi) to that of a static educational website to improve sleep, mood related symptoms, perceived health status, and overall quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

September 20, 2011

Last Update Submit

January 11, 2017

Conditions

InsomniaSleep Initiation and Maintenance Disorders

Keywords

sleepinsomniainternetCBT

Outcome Measures

Primary Outcomes (1)

  • Primary sleep symptoms: sleep onset latency (SOL), wake after sleep onset (WASO), insomnia severity (ISI)

    Baseline, 9 weeks, 6 months, 1 year

Secondary Outcomes (6)

  • Secondary sleep symptoms: sleep efficiency (SE), number of night time awakenings, sleep quality, total sleep time (TST)

    Baseline, 9 weeks, 6 months, 1 year

  • Psychological distress: levels of depression, levels of anxiety, sleep-related cognitions

    Baseline, 9 weeks, 6 months, 1 year

  • Health symptoms: fatigue, quality of life

    Baseline, 9 weeks, 6 months, 1 year

  • Cost effectiveness: program delivery cost, participant resource utilization and costs, quality adjusted life years (QALYs)

    9 weeks, 6 months, 1 year

  • Intervention Evaluation: perceived utility, perceived impact, intervention adherence, intervention use

    9 weeks, 6 months, 1 year

  • +1 more secondary outcomes

Study Arms (2)

Internet Intervention

EXPERIMENTAL

Assigned to Sleep Healthy Using the Internet (SHUTi)

Behavioral: Internet Intervention

Patient Education Website

ACTIVE COMPARATOR

Assigned to Patient Insomnia Educational Website

Behavioral: Patient Education Website

Interventions

Internet InterventionBEHAVIORAL

Participants will spend 1-2 hours each week for 9 weeks using the Internet intervention. Users will complete daily sleep diaries as well as interactive tutorials covering the topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progress through the program they will receive tailored instructions for how to improve their sleep.

Also known as: Sleep Healthy Using the Internet (SHUTi)
Internet Intervention
Patient Education WebsiteBEHAVIORAL

Participants will be given access to a relevant patient education website. It will contain material addressing the behaviors and symptoms of insomnia.

Patient Education Website

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 21 and 65 years old.
  • Have sleep-onset insomnia and/or sleep maintenance insomnia (\>30 minutes for at least 3 nights/week).
  • Have insomnia symptoms lasting at least 6 months.
  • Have an average total sleep time ≤ 6.5 hours.
  • Sleep disturbances (or associated daytime fatigue) cause significant distress or impairment in social, occupational, or other areas of functioning.
  • Have regular access to a computer and the Internet.
  • Reside in the United States or are US Citizens living outside the United States

You may not qualify if:

  • Pregnancy
  • Report of a physical illness which is deemed active, unstable, degenerative, and/or progressive, such as congestive heart failure, dementia, or acute pain.
  • Bipolar disorder as defined by a manic or hypomanic episode or treatment within the past 10 years.
  • Severe depression.
  • Endorse risk of suicide.
  • Endorse alcohol or drug abuse within the past year.
  • Presence of another untreated sleep disorder (e.g., sleep apnea, periodic leg movements).
  • Have irregular sleep schedules, with usual bedtimes earlier than 8:00pm or later than 2:00am or arising times earlier than 4:00am or later than 10:00am.
  • Current psychological treatment for insomnia.
  • Initiating psychological treatment within past 3 months.
  • Unstable medication regimen (change to schedule or dosage within past 3 months) for a medication regimen thought to impact sleep.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Division of Behavioral Health and Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (3)

  • Thorndike FP, Ritterband LM, Gonder-Frederick LA, Lord HR, Ingersoll KS, Morin CM. A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms. J Clin Psychol. 2013 Oct;69(10):1078-93. doi: 10.1002/jclp.22032. Epub 2013 Aug 28.

    PMID: 24014057RESULT

  • Quigg M, Gharai S, Ruland J, Schroeder C, Hodges M, Ingersoll KS, Thorndike FP, Yan G, Ritterband LM. Insomnia in epilepsy is associated with continuing seizures and worse quality of life. Epilepsy Res. 2016 May;122:91-6. doi: 10.1016/j.eplepsyres.2016.02.014. Epub 2016 Mar 2.

    PMID: 26994361RESULT

  • 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: 27902836RESULT

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Karen Ingersoll, PhD

    University Of Virginia Behavioral Health & Technology

    PRINCIPAL INVESTIGATOR

  • Lee M Ritterband, PhD

    University of Virginia Behavioral Health & Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychiatry and NB Sciences

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 22, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 12, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)