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Internet Delivered Self-help for Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851188
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
Jaap Lancee, Utrecht University

Tracking Information
First Submitted Date  ICMJE February 24, 2009
First Posted Date  ICMJE February 25, 2009
Last Update Posted Date June 13, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2010)
Sleep Diary [ Time Frame: 1 year ]
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
Insomnia [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2010)
  • Anxiety rating [ Time Frame: 1 year ]
    Measured with the HADS
  • Depression ratings [ Time Frame: 1 year ]
    Measured with the CES-D
  • Sleep medication [ Time Frame: 1 year ]
    Measured in the daily diary log
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
  • Anxiety [ Time Frame: 1 year ]
  • Depression [ Time Frame: 1 year ]
  • Sleep medication [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet Delivered Self-help for Insomnia
Official Title  ICMJE Not Provided
Brief Summary The current study aims to evaluate the effects of internet-delivered self-help CBT for insomnia through a randomised controlled trial. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be randomised into treatment groups or the waiting list. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Behavioral: Internet CBT self-help
    Internet based Cognitive behavioral self-help method for insomnia
  • Behavioral: CBT self-help booklet
    Cognitive behavioral self-help method for insomnia via booklet
  • Other: Waiting list
    Waiting list
Study Arms  ICMJE
  • Experimental: internet CBT self-help
    CBT via the internet
    Intervention: Behavioral: Internet CBT self-help
  • Experimental: CBT self-help booklet
    Intervention: Behavioral: CBT self-help booklet
  • Active Comparator: Waiting list
    Intervention: Other: Waiting list
Publications * Not Provided

*   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: February 24, 2009)
626
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Insomnia
  • Access to the internet

Exclusion Criteria:

  • Alcohol or substance abuse
  • Severe depression
  • Being suicidal
  • Sleep apnea
  • Schizophrenic or having a psychosis disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00851188
Other Study ID Numbers  ICMJE UU-vandenBout
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jaap Lancee, Utrecht University
Study Sponsor  ICMJE Jaap Lancee
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Utrecht University
Verification Date June 2012

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