NCT06827626

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Finnish Institute of Occupational Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Disturbed sleep and insomnia are common among shift workers, and disturbed sleep is considered a key factor in other health risks associated with shift work. However, there are no established treatment practices for treating insomnia in shift workers. This study aims to evaluate the effectiveness of Cognitive-Behavioural Therapy for Insomnia (CBT-I) tailored for social and health care sector shift workers whose work includes night shifts. Furthermore, the study will assess the shift workers' experiences of the acceptability and feasibility of CBT-I from their perspective. The study will also examine which features of shift work and employee characteristics promote or interfere with the effectiveness of the tailored CBT-I. The study is a randomised controlled trial. Participants will be shift workers in the social and health care sector who work in three or two shifts, including night shifts, and have significant insomnia symptoms. Participants will be recruited through occupational health services (OHS) and social media posts. The FIOH study group will carry out the measurements of the participants. Participants will complete the baseline measures (sleep diary, actigraphy and questionnaires) and then will be randomly assigned to receive the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session). The interventions will be delivered by the nurses of the participants´ OHS and the FIOH. Participants will complete the follow-up measures after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment. The results of the study can be utilised in OHS to guide and treat shift workers with insomnia as part of supporting their work ability.

Conditions

• Insomnia Chronic
• Shift Work Sleep Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive behavioral therapy for insomnia	Cognitive-Behavioural Therapy for Insomnia (CBT-I) includes behavioral methods, cognitive methods, and sleep hygiene counselling.
BEHAVIORAL	Sleep hygiene counselling	Sleep hygiene counselling includes common instructions to improve sleep.

Timeline

• Start date: 2025-02-17
• Primary completion: 2027-03-15
• Completion: 2027-03-31
• First posted: 2025-02-14
• Last updated: 2026-04-13

Locations

4 sites across 1 country: Finland