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Internet Delivered Self-Help CBT for Insomnia

This study has been completed.
Sponsor:
Information provided by:
Utrecht University
ClinicalTrials.gov Identifier:
NCT01224912
First received: October 18, 2010
Last updated: January 7, 2013
Last verified: January 2013

October 18, 2010
January 7, 2013
October 2010
December 2011   (final data collection date for primary outcome measure)
  • Sleep diary [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
  • Sleep diary [ Time Frame: 4-week follow-up ] [ Designated as safety issue: No ]
    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
  • Sleep diary [ Time Frame: 18-week follow-up ] [ Designated as safety issue: No ]
    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
  • Sleep diary [ Time Frame: 48-week follow-up ] [ Designated as safety issue: No ]
    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Same as current
Complete list of historical versions of study NCT01224912 on ClinicalTrials.gov Archive Site
  • Anxiety [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measured with the HADS
  • Anxiety [ Time Frame: 4-week follow-up ] [ Designated as safety issue: No ]
    HADS
  • Anxiety [ Time Frame: 18-week follow-up ] [ Designated as safety issue: No ]
    HADS
  • Anxiety [ Time Frame: 48-week follow-up ] [ Designated as safety issue: No ]
    HADS
  • Depression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    CES-D
  • Depression [ Time Frame: 4 week follow-up ] [ Designated as safety issue: No ]
    CES-D
  • Depression [ Time Frame: 18-week follow-up ] [ Designated as safety issue: No ]
    CES-D
  • Depression [ Time Frame: 48-week follow-up ] [ Designated as safety issue: No ]
    CES-D
  • Sleep medication [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Sleep medication as measured by the sleep diary
  • Sleep medication [ Time Frame: 4-week follow-up ] [ Designated as safety issue: No ]
    Sleep medication as measured by the sleep diary
  • Sleep medication [ Time Frame: 18-week follow-up ] [ Designated as safety issue: No ]
    Sleep medication as measured by the sleep diary
  • Sleep medication [ Time Frame: 48-week follow-up ] [ Designated as safety issue: No ]
    Sleep medication as measured by the sleep diary
  • Insomnia Severity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Insomnia Severity Index
  • Insomnia severity [ Time Frame: four-week follow-up ] [ Designated as safety issue: No ]
    Insomnia Severity Index
  • Insomnia severity [ Time Frame: 18-week follow-up ] [ Designated as safety issue: No ]
    Insomnia Severity Index
  • Insomnia severity [ Time Frame: 48-week follow-up ] [ Designated as safety issue: No ]
    Insomnia Severity Index
Same as current
Not Provided
Not Provided
 
Internet Delivered Self-Help CBT for Insomnia
Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention

The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Insomnia
Behavioral: Cognitive Behavioral Treatment
The techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow).
Experimental: Internet Deliviered CBT for Insomnia
Cognitive behavioral self-help method for insomnia via the Internet
Intervention: Behavioral: Cognitive Behavioral Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
479
October 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Insomnia
  • Access to the internet

Exclusion Criteria:

  • Alcohol or substance abuse
  • Being suicidal
  • Sleep apnea
  • Schizophrenic or having a psychosis disorder
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01224912
UU-vandenBout-2
Yes
Utrecht University
Utrecht University
Not Provided
Principal Investigator: Jaap Lancee, MSc Utrecht University
Utrecht University
January 2013

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