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

Phase

N/A

Condition

Sleep Disorders

Narcolepsy

Treatment

Cognitive behavioral therapy for insomnia

Sleep hygiene counselling

Clinical Study ID

NCT06827626

4025601

Ages 18-65
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

non-assessed or untreated clinically significant somatic or mental symptoms orillnesses or other sleep disorders that could explain current insomnia symptoms
earlier participation to CBT-I
other ongoing or planned psychotherapeutic/psychological intervention

Study Design

Cognitive behavioral therapy for insomnia

February 17, 2025

January 29, 2027

Study 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.

Connect with a study center

Terveystalo Oyj
Helsinki, Uusima FI-00100
Finland
Active - Recruiting
Finnish Institute of Occupational Health
Helsinki, Uusimaa FI-00032
Finland
Active - Recruiting
Joint Authority HUS
Helsinki, Uusimaa FI-00029
Finland
Active - Recruiting
The Wellbeing Services County of South Ostrobotnia and TT Botnia Oy
Seinäjoki and Vaasa,
Finland
Site Not Available

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