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Internet Delivered Self-help for Insomnia

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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

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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Internet CBT self-help Behavioral: CBT self-help booklet Other: Waiting list Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 626 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: internet CBT self-help
CBT via the internet
Behavioral: Internet CBT self-help
Internet based Cognitive behavioral self-help method for insomnia

Experimental: CBT self-help booklet Behavioral: CBT self-help booklet
Cognitive behavioral self-help method for insomnia via booklet

Active Comparator: Waiting list Other: Waiting list
Waiting list




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Anxiety rating [ Time Frame: 1 year ]
    Measured with the HADS

  2. Depression ratings [ Time Frame: 1 year ]
    Measured with the CES-D

  3. Sleep medication [ Time Frame: 1 year ]
    Measured in the daily diary log



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851188


Locations
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Netherlands
Utrecht University
Utrecht, Netherlands, 3508TC
Sponsors and Collaborators
Jaap Lancee

Additional Information:
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Responsible Party: Jaap Lancee, PhD, Utrecht University
ClinicalTrials.gov Identifier: NCT00851188     History of Changes
Other Study ID Numbers: UU-vandenBout
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders