NCT00851188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
626

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

February 24, 2009

Last Update Submit

June 12, 2012

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Anxiety rating

    1 year

  • Depression ratings

    1 year

  • Sleep medication

    1 year

Study Arms (3)

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

Internet CBT self-helpBEHAVIORAL

Internet based Cognitive behavioral self-help method for insomnia

internet CBT self-help
CBT self-help bookletBEHAVIORAL

Cognitive behavioral self-help method for insomnia via booklet

CBT self-help booklet
Waiting listOTHER

Waiting list

Waiting list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insomnia
  • Access to the internet

You may not qualify if:

  • Alcohol or substance abuse
  • Severe depression
  • Being suicidal
  • Sleep apnea
  • Schizophrenic or having a psychosis disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utrecht University

Utrecht, Utrecht, 3508TC, Netherlands

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

NL(1)