Shift-work DisorderNCT05633498
Self-help Book for Shift Work Related Problems
A study testing Book and Sleep hygiene in people with Shift-work Disorder, run by University of Bergen at 1 site in Norway.
Trial summary
The aim is to assess whether a self-help book for coping with shift work will reduce complaints in relation to shift work. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shift-work Disorder
- What is being tested?
- Book and Sleep hygiene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteNorway
- Study dates
- 18 Nov 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptoms suggesting shift work disorder
- Health care worker
Who cannot join
- Below 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Shift-work Disorder
- Being tested
- Book, Sleep hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BookOther
Self-help book describing advice to cope with shift work
Sleep hygieneOther
Basic sleep hygiene advice on a piece of paper
| Study group | Role | What they receive |
|---|---|---|
| Self-help book | Experimental | A self-help book for coping with shift work Receives: Other: Book |
| Sleep hygiene advice | Active comparator | A sheet of paper with basic and standard sleep hygiene advice Receives: Other: Sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep problems
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.
Measured: 6 months
Sleepiness problems
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.
Measured: 6 months
Secondary outcomes (4)
Shift work disorder
Prevalence of shift work disorder based on international criteria
Measured: 6 months
Knowledge about shift work and health
Questions about sleep, circadian rhythms and shift work
Measured: 6 months
Sick leave
Self-reported sickness absence
Measured: 6 months
Turnover intention
Self-reported turnover intention on a validated scale (TI) with scores ranging from 0 to 4 with higher values indicating more turnover intention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start18 Nov 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shift-work DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633498
- Sponsor's protocol ID
- HEWOS_RCT_SWD2022
- Status last verified
- Dec 2024
- First submitted
- 21 Nov 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waage S, Harris A, Vedaa O, Pallesen S, Sunde E, Bjorvatn B. The effect of a self-help book for shift work disorder - a randomized controlled trial. Front Psychiatry. 2026 Aug 26;17:1829148. doi: 10.3389/fpsyt.2026.1829148. eCollection 2026.
PubMed 42718571
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Self-help Book for Shift Work Related Problems - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05633498
- Acronym / sponsor ID
- HEWOS_RCT_SWD2022
- Conditions
- Shift-work Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to assess whether a self-help book for coping with shift work will reduce complaints in relation to shift work.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help book | Experimental | Other: BookA self-help book for coping with shift work |
| Sleep hygiene advice | Active comparator | Other: Sleep hygieneA sheet of paper with basic and standard sleep hygiene advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptoms suggesting shift work disorder
- Health care worker
Key exclusion criteria (1 listed)
- Below 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BookSelf-help book describing advice to cope with shift work | Other | Self-help book |
| Sleep hygieneBasic sleep hygiene advice on a piece of paper | Other | Sleep hygiene advice |
Primary outcome
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.
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.
4 secondary outcomes
Shift work disorder
Time frame: 6 months
Knowledge about shift work and health
Time frame: 6 months
Sick leave
Time frame: 6 months
Turnover intention
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42718571Waage S, Harris A, Vedaa O, Pallesen S, Sunde E, Bjorvatn B. The effect of a self-help book for shift work disorder - a randomized controlled trial. Front Psychiatry. 2026 Aug 26;17:1829148. doi: 10.3389/fpsyt.2026.1829148. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Book and Sleep hygiene in people with Shift-work Disorder, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep problems (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05633498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.