Online or Face-to-face Treatment for Insomnia?
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 30, 2014
December 1, 2014
6 months
September 20, 2013
December 29, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)
For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary.
Change from baseline to post-test, 3-months, and 6-months follow-up
Insomnia Severity Index
Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary Outcomes (6)
Anxiety (HADS-A)
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
Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related arousal measured with the Pre-arousal sleep scale
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)
Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep medication usage per day measured with the sleep diary
Change from baseline to post-test, 3-months, and 6-months follow-up
- +1 more secondary outcomes
Study Arms (3)
Internet-delivered CBT for insomnia
EXPERIMENTALOnline Cognitive behavioral treatment for insomnia
Face-to-face CBT for insomnia
EXPERIMENTALFace-to-face Cognitive behavioral treatment for insomnia
Waiting-list
NO INTERVENTIONWaiting-list
Interventions
Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VU University of Amsterdamlead
- Slaapmakendcollaborator
Study Sites (1)
Department of Clinical Psychology
Amsterdam, North Holland, 1018XA, Netherlands
Related Publications (2)
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.
PMID: 22055281BACKGROUNDLancee 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.
PMID: 26414893DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaap Lancee, PhD
University of Amsterdam
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
September 20, 2013
First Posted
October 8, 2013
Study Start
October 1, 2013
Primary Completion
April 1, 2014
Study Completion
December 1, 2014
Last Updated
December 30, 2014
Record last verified: 2014-12