- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05633498
Self-help Book for Shift Work Related Problems
April 30, 2026 updated by: University of Bergen
The Effect of a Self-help Book for Shift Work Related Problems - a Randomized Controlled Trial
The aim is to assess whether a self-help book for coping with shift work will reduce complaints in relation to shift work.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial evaluating the effect of a self-help book for shift work related problems compared to the effect of sleep hygiene advice in participants with shift work disorder.
300 participants will be randomized to receive either the book or the sleep hygiene advice.
Participants complete questionnaires about sleep, sleepiness and health at baseline and after 6 months after receiving the written material.
The main aims are to assess whether the book is more effective to reduce sleep and sleepiness problems in relation to shift work, and to reduce the prevalence of shift work disorder, to increase knowledge about sleep and circadian rhythms, improve health, and reduce turnover intention.
Study Type
Interventional
Enrollment (Actual)
199
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hordaland
-
Bergen, Hordaland, Norway, 5018
- University of Bergen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Symptoms suggesting shift work disorder
- Health care worker
Exclusion Criteria:
- Below 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-help book
A self-help book for coping with shift work
|
Self-help book describing advice to cope with shift work
|
|
Active Comparator: Sleep hygiene advice
A sheet of paper with basic and standard sleep hygiene advice
|
Basic sleep hygiene advice on a piece of paper
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep problems
Time Frame: 6 months
|
Self-reported sleep problems in relation to shift work on a validated scale - Bergen Shift Work Sleep Questionnaire (BSWSQ).
Questions range from 0 to 4 with higher values indicating more sleep problems.
|
6 months
|
|
Sleepiness problems
Time Frame: 6 months
|
Self-reported sleepiness in relation to shift work on a validated scale - Bergen Shift Work Sleep Questionnaire (BSWSQ).
Questions range from 0 to 4 with higher values indicating more sleepiness.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shift work disorder
Time Frame: 6 months
|
Prevalence of shift work disorder based on international criteria
|
6 months
|
|
Knowledge about shift work and health
Time Frame: 6 months
|
Questions about sleep, circadian rhythms and shift work
|
6 months
|
|
Sick leave
Time Frame: 6 months
|
Self-reported sickness absence
|
6 months
|
|
Turnover intention
Time Frame: 6 months
|
Self-reported turnover intention on a validated scale (TI) with scores ranging from 0 to 4 with higher values indicating more turnover intention.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2022
Primary Completion (Actual)
January 1, 2025
Study Completion (Actual)
January 1, 2025
Study Registration Dates
First Submitted
November 21, 2022
First Submitted That Met QC Criteria
November 21, 2022
First Posted (Actual)
December 1, 2022
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- HEWOS_RCT_SWD2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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