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Online or Face-to-face Treatment for Insomnia?

NCT ID: NCT01955850

Last Updated: 2014-12-30

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

PHASE3

Total Enrollment

90 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 face-to-face treatment and a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. Both the online and face-to-face 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 fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. Participants on the waiting-list receive online treatment after the first post-test. The investigators expect that the online-delivered treatment and the face-to-face treatment are equally effective.

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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Internet-delivered CBT for insomnia

Online Cognitive behavioral treatment for insomnia

Group Type EXPERIMENTAL

Cognitive behavioral treatment for insomnia

Intervention Type BEHAVIORAL

Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.

Face-to-face CBT for insomnia

Face-to-face Cognitive behavioral treatment for insomnia

Group Type EXPERIMENTAL

Cognitive behavioral treatment for insomnia

Intervention Type BEHAVIORAL

Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.

Waiting-list

Waiting-list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive behavioral treatment for insomnia

Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.

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
* Possibility to travel to one of the treatment sites

Exclusion Criteria

* Earlier cognitive behavioral treatment for insomnia
* Start other psychological treatment in the last 6 months
* Doing shift work
* Major depression disorder
* 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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Slaapmakend

UNKNOWN

Sponsor Role collaborator

VU University of Amsterdam

OTHER

Sponsor Role lead

Responsible Party

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Jaap Lancee

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaap Lancee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Amsterdam

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, van den Bout J, van Straten A, Spoormaker VI. Internet-delivered or mailed self-help treatment for insomnia?: a randomized waiting-list controlled trial. Behav Res Ther. 2012 Jan;50(1):22-9. doi: 10.1016/j.brat.2011.09.012. Epub 2011 Oct 24.

Reference Type BACKGROUND
PMID: 22055281 (View on PubMed)

Lancee J, van Straten A, Morina N, Kaldo V, Kamphuis JH. Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial. Sleep. 2016 Jan 1;39(1):183-91. doi: 10.5665/sleep.5344.

Reference Type DERIVED
PMID: 26414893 (View on PubMed)

Related Links

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http://www.insomnie.nl

General website for insomnia and used for the recruitment

Other Identifiers

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UvA-2013-KP-3125

Identifier Type: -

Identifier Source: org_study_id