Study Results
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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COMPLETED
NA
148 participants
INTERVENTIONAL
2022-09-20
2023-11-11
Brief Summary
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The second aim in this study is to determine mechanisms behind treatments. Network intervention analysis will be used to determine which specific symptoms are associated with therapy success. This is the reason that throughout the study weekly and daily measures will be conducted.
The expectations are that:
* Participants in the sleep restriction condition will improve more on insomnia complaints than the sleep diary control condition (primary outcome)
* Participants in the sleep restriction condition will improve more on sleep diary outcomes and other secondary outcomes compared to the sleep diary control condition (secondary outcome)
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sleep restriction treatment
In this condition participants receive a behavioral sleep restriction intervention for six weeks
sleep restriction treatment
Treatment consists of sleep restriction treatment for insomnia. In this treatment, participants limit their bedtimes to the time they actually sleep. If they sleep most of the time in bed again then bedtimes are slowly built up again. This treatment technique has already been studied in several trials and found to be effective.
Mode of delivery is an online booklet, online exercises and weekly telephone support
Sleep monitoring
In this control condition people fill out a sleep diary for six weeks
sleep diary monitoring
As an active control condition people monitor their sleep with a sleep diary (also included in the sleep restriction intervention)
Interventions
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sleep restriction treatment
Treatment consists of sleep restriction treatment for insomnia. In this treatment, participants limit their bedtimes to the time they actually sleep. If they sleep most of the time in bed again then bedtimes are slowly built up again. This treatment technique has already been studied in several trials and found to be effective.
Mode of delivery is an online booklet, online exercises and weekly telephone support
sleep diary monitoring
As an active control condition people monitor their sleep with a sleep diary (also included in the sleep restriction intervention)
Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* Self reported insomnia complaints: being awake ≥30 minutes per night, ≥3 nights per week, ≥ 3 months
* Daytime problems related to sleep complaints
* Sleep efficiency \< 85%
* Dutch speaking
Exclusion Criteria
* (2) Pregnant or breastfeeding
* (3) working in night shifts
* (4) currently in psychological treatment (started \< 6 months) or on wait-list for treatment
* (5) cognitive behavioral treatment for insomnia in last 12 months
* (6) concrete suicidal ideation
* (7) schizophrenic or psychotic disorder
* (8) high level of depressive complaints (BDI-II \> 28)
* (9) Instable medication use (medication should not be tampered in last 6 weeks) incidental sleep-medication use is allowed
18 Years
ALL
Yes
Sponsors
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VU University of Amsterdam
OTHER
Responsible Party
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Jaap Lancee
Assistant Professor
Principal Investigators
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Jaap Lancee, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Amsterdam
Locations
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University of Amsterdam
Amsterdam, North Holland, Netherlands
Countries
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References
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Looman MI, Blanken TF, Schoenmakers TM, Reesen JE, Effting M, Linnebank FE, van Straten A, Kamphuis JH, Lancee J. Telephone-Guided Sleep Restriction for Insomnia: A Randomized Sleep Diary-Controlled Trial. Psychother Psychosom. 2025;94(3):147-161. doi: 10.1159/000545138. Epub 2025 Mar 21.
Other Identifiers
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2022-CP-15342
Identifier Type: -
Identifier Source: org_study_id