Clinical trial NCT06827626: Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care
Official title: Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Shift Work Sleep Disorder
Keywords: Shift work
Insomnia
Shift work sleep disorder
CBT-I
Occupational Health Services
Lead sponsor: Finnish Institute of Occupational Health
Sponsor class: OTHER
Collaborators: name: Finnish Work Environment Fund
name: Terveystalo Oyj
name: Joint Authority HUS
First posted: 2025-02-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Change from baseline in means of insomnia symptoms assessed by sleep diary 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.
measure: Change from baseline in means of insomnia symptoms assessed by actigraphy 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.
measure: Change from baseline in shift work disorder case 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.
measure: Change from baseline in mean insomnia reactivity 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.
measure: Change from baseline in mean of sleep-related dysfunctional cognitions 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.
measure: Change from baseline in mean daytime sleepiness 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.
measure: Change from baseline in mean depression severity 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.
measure: Change from baseline in mean anxiety disorder symptoms 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.
measure: Change from baseline in mean burnout symptoms 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.
measure: Change from baseline in mean quality of life 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.
measure: Change from baseline in mean self-rated work ability 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.
measure: Change from baseline in mean recovery 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.
Other outcomes:
measure: Implementation experiences of the interventions
timeFrame: After the end of treatment (12 weeks after the first session)
measure: Global effectiveness of the treatment
timeFrame: After the end of treatment (12 weeks after the first session)
measure: Demographic and background information about participants´ work and health
timeFrame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
measure: Perceived helpfulness and feasibility per treatment session
timeFrame: After each intervention session
Locations:
city: Helsinki
country: Finland
facility: Joint Authority HUS
state: Uusimaa
city: Helsinki
country: Finland
facility: Finnish Institute of Occupational Health
state: Uusimaa
city: Helsinki
country: Finland
facility: Terveystalo Oyj
state: Uusima
city: Seinäjoki and Vaasa
country: Finland
facility: The Wellbeing Services County of South Ostrobotnia and TT Botnia Oy
Study officials:
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