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

NCT ID: NCT01955928

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Online Cognitive behavioral treatment for insomnia

Online Cognitive behavioral treatment for insomnia

Group Type EXPERIMENTAL

Online Cognitive behavioral treatment for insomnia

Intervention Type BEHAVIORAL

Waiting-list

Waiting-list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Online Cognitive behavioral treatment for insomnia

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VU University of Amsterdam

OTHER

Sponsor Role lead

Responsible Party

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Jaap Lancee

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Psychology

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Lancee J, Eisma MC, van Straten A, Kamphuis JH. Sleep-Related Safety Behaviors and Dysfunctional Beliefs Mediate the Efficacy of Online CBT for Insomnia: A Randomized Controlled Trial. Cogn Behav Ther. 2015;44(5):406-22. doi: 10.1080/16506073.2015.1026386. Epub 2015 May 27.

Reference Type RESULT
PMID: 26012890 (View on PubMed)

Related Links

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http://www.insomnie.nl

General website about insomnia

Other Identifiers

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UvA-2013-KP-3152

Identifier Type: -

Identifier Source: org_study_id

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