Internet Delivered Self-help for Insomnia | NCT00851188

Studies
Internet Delivered Self-help for Insomnia

NCT00851188

Sponsor

Jaap Lancee

Status

Completed

Last Update Posted

Jun 13, 2012Estimated

Enrollment

626Actual

Phase

Not Applicable

Conditions

Insomnia

Interventions

Internet CBT self-help
CBT self-help booklet
Waiting list

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Feb 24, 2009

First Submission Date that Met QC Criteria

Feb 24, 2009

First Posted Date

Feb 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2012

Last Update Posted Date

Jun 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

626Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
internet CBT self-help	Experimental	CBT via the internet	Behavioral: Internet CBT self-help
CBT self-help booklet	Experimental		Behavioral: CBT self-help booklet
Waiting list	Active Comparator		Other: Waiting list

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Internet CBT self-help	Behavioral	Internet based Cognitive behavioral self-help method for insomnia	internet CBT self-help

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep Diary	Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Anxiety rating	Measured with the HADS	1 year
Depression ratings	Measured with the CES-D	1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Utrecht University		Utrecht	Utrecht	3508TC	Netherlands

Label	URL
Popular-Scientific website about insomnia	View source

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014850	Waiting Lists

Ancestor Terms

ID	Term
D001071	Appointments and Schedules
D009934	Organization and Administration
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided