Active — Not RecruitingNot Applicable

Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care

Finland84 participantsStarted 2025-02-17

Plain-language summary

The goal of this clinical trial is to evaluate the usefulness of cognitive behavioural therapy for insomnia (CBT-I) tailored to shift workers in the social and health care sector. The study will also learn about the shift workers' experiences of the acceptability and feasibility of CBT-I and investigate which features of shift work and individual characteristics promote or interfere with the effectiveness of the tailored CBT-I. The main question the study aims to answer is: • Does CBT-I tailored to shift workers in the social and health care sector improve perceived insomnia severity, insomnia symptoms, mental health and quality of life? Researchers will compare CBT-I to a control intervention (short sleep hygiene counselling) to see if CBT-I works to treat insomnia in shift workers. Participants will: * Participate in the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session) * Complete the measures (sleep diary, actigraphy and questionnaires) at baseline, after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 18-65 years * working in social and heath care sector * 3- or 2-shift work including night shift at least once per month * full time or nearly full time shift work (75-100 %) * Insomnia Severity Index score \> 10 * duration of insomnia symptoms at least 3 months * shift work continuing for at least the next year * sufficient Finnish language skills (coaching materials in Finnish only) Exclusion Criteria: * non-assessed or untreated clinically significant somatic or mental symptoms or illnesses or other sleep disorders that could explain current insomnia symptoms * earlier participation to CBT-I * other ongoing or planned psychotherapeutic/psychological intervention

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in mean of Insomnia Severity Index at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.

Timeframe: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.

Trial details

NCT IDNCT06827626

SponsorFinnish Institute of Occupational Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-15

View on ClinicalTrials.gov More Insomnia Chronic trials