Internet Delivered Self-Help for Insomnia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 24, 2009

Last Updated Date

February 24, 2009

Start Date ^†

January 2009

Current Primary Outcome Measures ^†

Insomnia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Internet Delivered Self-Help for Insomnia

Official Title ^†

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

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Condition ^†

Insomnia

Intervention ^†

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

Study Arms / Comparison Groups

Experimental: CBT via the internet

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

626

Estimated Completion Date

April 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Jaap Lancee, MSc

0031 253 2387

j.lancee@uu.nl

Location Countries ^†

Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00851188

Responsible Party

Utrecht University, Utrecht University

Secondary IDs ^††

Study Sponsor ^†

Utrecht University

Collaborators ^††

Investigators ^†

Information Provided By

Utrecht University

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.