Internet-delivered CBT for Insomnia: Role of Sleep-related Cognitions

October 10, 2018 updated by: Jaap Lancee, VU University of Amsterdam
The object of this study is to compare internet-delivered treatment for insomnia to a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral 2) waiting-list. Participants in the waiting-list condition receive treatment after the post-test. The interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. In this study we are interested in sleep-related worry and daily complaints measured with a diary. We expect that the online intervention ameliorates both the sleep-related worry and the daily complaints. Furthermore, we expect that the sleep related worry mediates the effect of the intervention on sleep- and daily complaints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

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
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1018XA
        • Department of Clinical Psychology

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Insomnia disorder according to DSM-5
  • Sleep onset latency/wake after sleep onset > 30 minutes , three times or more a week
  • Insomnia three months or longer
  • Access to internet

Exclusion Criteria:

  • Earlier cognitive behavioral treatment for insomnia
  • Start other psychological treatment in the last 6 months
  • Doing shift work
  • Pregnancy or breast feeding
  • Schizophrenia or psychosis
  • Suicidal plans
  • Sleep apnea
  • drugs or alcohol abuse

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waiting-list
Experimental: Online Cognitive behavioral treatment for insomnia
Behavioral: Online Cognitive behavioral treatment for insomnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daytime symptoms of sleep related worry measured with the APSQ
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Daytime symptoms of sleep related worry will be measured with a daily Anxiety and Pre-occupation about sleep questionnaire.
Change from baseline to post-test, 3-months, and 6-months follow-up
Daytime symptoms measured with diary consisting of the DASS-21
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
The daytime symptoms will be measured with the 7 items of the stress scale of the DASS-21
Change from baseline to post-test, 3-months, and 6-months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression measured with the CES-D
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Change from baseline to post-test, 3-months, and 6-months follow-up
Anxiety measured with the HADS-A
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related safety behaviors measured with the SRBQ
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related arousal measured with the Pre-arousal sleep scale
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Change from baseline to post-test, 3-months, and 6-months follow-up
Repetitive thinking measured with the Dutch Perseverative Thinking Questionnaire
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep medication usage per day measured with the sleep diary
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Change from baseline to post-test, 3-months, and 6-months follow-up
sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)
Time Frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep continuity is measured with a 7-day sleep diary based on the consensus sleep diary.
Change from baseline to post-test, 3-months, and 6-months follow-up

Collaborators and Investigators

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

Sponsor

VU University of Amsterdam

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.

General Publications

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, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 21, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UvA-2013-KP-3152

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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