Sleep Restriction Treatment for Insomnia

NCT05548907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2023-12-22

No results posted yet for this study

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)

Conditions

Interventions

BEHAVIORAL

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

BEHAVIORAL

sleep diary monitoring

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

Sponsors & Collaborators

  • VU University of Amsterdam

    lead OTHER

Principal Investigators

  • Jaap Lancee, PhD · University of Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2023-11-11
Completion
2023-11-11

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05548907 on ClinicalTrials.gov