CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 148 enrolled
Drug / intervention
sleep restriction treatment +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05548907
NCT05548907N/ACompleted

Sleep Restriction Treatment for Insomnia: a Randomized Controlled Trial

VU University of Amsterdam·interventional·Posted Sep 22, 2022·Updated Dec 22, 2023

In Brief

A clinical study evaluating sleep restriction treatment and sleep diary monitoring for Insomnia. Completed, enrolled 148 participants across 1 site.

Detailed Summary

With a prevalence of about 10% chronic insomnia is a common problem. The standard treatment for insomnia is cognitive behavioral therapy. According to many, the core element within this treatment is sleep restriction. This element has been examined separately in a couple of studies and also appears to be effective in isolation. In the current study the aim is to get more information about the effectiveness of this core element of the treatment. For this reason, a randomized study is conducted to compare sleep restriction with a diary control condition. 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 22, 2022
Enrollment StartSep 20, 2022
Primary CompletionNov 11, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.8 years ago

Interventions

sleep restriction treatmentbehavioral

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 monitoringbehavioral

As an active control condition people monitor their sleep with a sleep diary (also included in the sleep restriction intervention)