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Internet Delivered Self-help for Insomnia
This study is ongoing, but not recruiting participants.
First Received: February 24, 2009   Last Updated: July 28, 2009   History of Changes
Sponsored by: Utrecht University
Information provided by: Utrecht University
ClinicalTrials.gov Identifier: NCT00851188
  Purpose

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 Intervention
Insomnia
 Behavioral: Internet CBT self-help
Behavioral: CBT self-help booklet
Other: Waiting list

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Further study details as provided by Utrecht University:

Primary Outcome Measures:
  • Insomnia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Sleep medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 626
Study Start Date: January 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
internet CBT self-help: Experimental
CBT via the internet
Behavioral: Internet CBT self-help
Internet based Cognitive behavioral self-help method for insomnia
CBT self-help booklet: Experimental Behavioral: CBT self-help booklet
Cognitive behavioral self-help method for insomnia via booklet
Waiting list: Active Comparator Other: Waiting list
Waiting list

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851188

Locations
Netherlands
Utrecht University
Utrecht, Netherlands, 3508TC
Sponsors and Collaborators
Utrecht University
  More Information

Additional Information:
Popular-Scientific website about insomnia  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Utrecht University ( Utrecht University )
Study ID Numbers: UU-vandenBout
Study First Received: February 24, 2009
Last Updated: July 28, 2009
ClinicalTrials.gov Identifier: NCT00851188     History of Changes
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

ClinicalTrials.gov processed this record on September 10, 2009



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