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Internet Delivered Self-help for Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Internet CBT self-help
CBT self-help booklet
Waiting list
Sponsored by
Jaap Lancee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Utrecht University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

internet CBT self-help

CBT self-help booklet

Waiting list

Arm Description

CBT via the internet

Outcomes

Primary Outcome Measures

Sleep Diary
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

Secondary Outcome Measures

Anxiety rating
Measured with the HADS
Depression ratings
Measured with the CES-D
Sleep medication
Measured in the daily diary log

Full Information

First Posted
February 24, 2009
Last Updated
June 12, 2012
Sponsor
Jaap Lancee
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1. Study Identification

Unique Protocol Identification Number
NCT00851188
Brief Title
Internet Delivered Self-help for Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jaap Lancee

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
626 (Actual)

8. Arms, Groups, and Interventions

Arm Title
internet CBT self-help
Arm Type
Experimental
Arm Description
CBT via the internet
Arm Title
CBT self-help booklet
Arm Type
Experimental
Arm Title
Waiting list
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Internet CBT self-help
Intervention Description
Internet based Cognitive behavioral self-help method for insomnia
Intervention Type
Behavioral
Intervention Name(s)
CBT self-help booklet
Intervention Description
Cognitive behavioral self-help method for insomnia via booklet
Intervention Type
Other
Intervention Name(s)
Waiting list
Intervention Description
Waiting list
Primary Outcome Measure Information:
Title
Sleep Diary
Description
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Anxiety rating
Description
Measured with the HADS
Time Frame
1 year
Title
Depression ratings
Description
Measured with the CES-D
Time Frame
1 year
Title
Sleep medication
Description
Measured in the daily diary log
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Utrecht University
City
Utrecht
ZIP/Postal Code
3508TC
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.insomnie.nl
Description
Popular-Scientific website about insomnia

Learn more about this trial

Internet Delivered Self-help for Insomnia

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