Internet Delivered Self-Help CBT for Insomnia

January 7, 2013 updated by: Utrecht University

Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention

The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

479

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508TC
        • Utrecht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Insomnia
  • Access to the internet

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Internet Deliviered CBT for Insomnia
Cognitive behavioral self-help method for insomnia via the Internet
Behavioral: Cognitive Behavioral Treatment
The techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep diary
Time Frame: baseline
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
baseline
Sleep diary
Time Frame: 4-week follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
4-week follow-up
Sleep diary
Time Frame: 18-week follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
18-week follow-up
Sleep diary
Time Frame: 48-week follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
48-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Baseline
Measured with the HADS
Baseline
Anxiety
Time Frame: 4-week follow-up
HADS
4-week follow-up
Anxiety
Time Frame: 18-week follow-up
HADS
18-week follow-up
Anxiety
Time Frame: 48-week follow-up
HADS
48-week follow-up
Depression
Time Frame: Baseline
CES-D
Baseline
Depression
Time Frame: 4 week follow-up
CES-D
4 week follow-up
Depression
Time Frame: 18-week follow-up
CES-D
18-week follow-up
Depression
Time Frame: 48-week follow-up
CES-D
48-week follow-up
Sleep medication
Time Frame: Baseline
Sleep medication as measured by the sleep diary
Baseline
Sleep medication
Time Frame: 4-week follow-up
Sleep medication as measured by the sleep diary
4-week follow-up
Sleep medication
Time Frame: 18-week follow-up
Sleep medication as measured by the sleep diary
18-week follow-up
Sleep medication
Time Frame: 48-week follow-up
Sleep medication as measured by the sleep diary
48-week follow-up
Insomnia Severity
Time Frame: Baseline
Insomnia Severity Index
Baseline
Insomnia severity
Time Frame: four-week follow-up
Insomnia Severity Index
four-week follow-up
Insomnia severity
Time Frame: 18-week follow-up
Insomnia Severity Index
18-week follow-up
Insomnia severity
Time Frame: 48-week follow-up
Insomnia Severity Index
48-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Utrecht University

Investigators

  • Principal Investigator: Jaap Lancee, MSc, Utrecht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (ESTIMATE)

October 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU-vandenBout-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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