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Internet-based Treatment for Chronic Insomnia

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ClinicalTrials.gov Identifier: NCT00821041
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : September 16, 2011
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Nora Vincent, University of Manitoba

Tracking Information
First Submitted Date  ICMJE January 8, 2009
First Posted Date  ICMJE January 12, 2009
Results First Submitted Date  ICMJE May 5, 2011
Results First Posted Date  ICMJE September 16, 2011
Last Update Posted Date August 8, 2013
Study Start Date  ICMJE September 2006
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2011)
Sleep Quality [ Time Frame: 6 weeks ]
Sleep Quality was assessed by taking the average of two items: "How well do you feel this morning?" And "How enjoyable was your sleep last night?" (0 = not at all, 4 = very).
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
Sleep Quality [ Time Frame: 5 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2011)
  • Pre-Sleep Arousal [ Time Frame: 6 weeks ]
    Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal.
  • Beliefs and Attitudes About Sleep [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
  • Pre-Sleep Arousal [ Time Frame: 5 weeks ]
  • Beliefs and Attitudes About Sleep [ Time Frame: 5 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet-based Treatment for Chronic Insomnia
Official Title  ICMJE Evaluation of an Internet-based Treatment for Chronic Insomnia
Brief Summary

Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia.

Design This is a randomized controlled trial with online treatment and waiting list control conditions.

Participants

Participants are adults in Manitoba Canada with chronic insomnia.

Setting

Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Insomnia Disorder
Intervention  ICMJE Behavioral: Cognitive Behavioral Therapy
6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training
Other Name: CBT
Study Arms  ICMJE
  • No Intervention: Waiting list control
  • Experimental: CBT
    A 6 weeks online course. Each week participants log on to view videos and read information that focus on a variety of intervention techniques. These include relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training. Participants also monitor their sleep using an online sleep diary and respond to questions regarding their adherence to the program.
    Intervention: Behavioral: Cognitive Behavioral Therapy
Publications * Vincent N, Walsh K, Lewycky S. Determinants of success for computerized cognitive behavior therapy: examination of an insomnia program. Behav Sleep Med. 2013;11(5):328-42. doi: 10.1080/15402002.2012.700662. Epub 2013 Jan 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2011)
118
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)
200
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Access to high speed internet, insomnia duration > 6 months and occurring at least 4 nights per week, sleep-onset latency > 30 minutes and/or time awake at night > 30 minutes, and/or early morning awakening > 30 minutes before desired time, at least one type of daytime impairment.

Exclusion Criteria:

  • Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake > 14 drinks/week for males, > 12 drinks per week for females, current or past behavioral treatment for insomnia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00821041
Other Study ID Numbers  ICMJE H2004:112
HSCF 176
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Nora Vincent, University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Norah Vincent, Ph.D. University of Manitoba
PRS Account University of Manitoba
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP