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

Not Applicable

Recruiting

• Conditions: Insomnia Chronic; Shift Work Sleep Disorder

• Registration Number: NCT06827626
• Lead Sponsor: Finnish Institute of Occupational Health

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.

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-14
• Study Start: 2025-02-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	Insomnia Severity Index (ISI) contains seven items about insomnia during the last month \[item scale 0 (not at all) -4 (very severe)\]. The sum of the scores serves as the ISI score.

Secondary Outcome Measures

Name	Time	Method
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	Insomnia symptoms are assessed by sleep diary. It is completed using a mobile phone app (Experience Sampling Platform - movisensXS - movisens GmbH). The sleep diary contains questions about the timing of the sleep period, sleep onset latency, wake after sleep onset, number of awakenings after sleep onset, sleep quality, time spent in bed, restedness after sleep, use of sleep-promoting medication, working times, recovery from work, naps and their timing. Total sleep time and sleep efficiency are calculated from the responses. The averages will serve as the outcomes. Participants will keep the sleep diary for 1-2 weeks at each measurement period.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	Insomnia symptoms are also assessed using the Actigraphy Link GT9X. Actigraphy recording is conducted for 1-2 weeks at the same time as the sleep diary. From the actigraphy data, we analyse sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, naps and their timing. The averages will serve as the outcomes.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	Shift-specific questions on insomnia and sleepiness (SS-Q) -questionnaire measures separately sleepiness and insomnia symptoms in three different shifts (morning, evening and night shifts) and while on holiday over two weeks \[item scale 1 (never) - 5 (always)\]. Shift work disorder (SWD) cases has to report sleepiness and/or insomnia "never" or "rarely" while on holiday and the never or rarely occurring symptom "often" or "always" in connection to some shift type/types. SWD score \[0 (no SWD) or 1(SWD case)\] is used as outcome.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	The Ford Insomnia Response to Stress Test (FIRST) contains nine items about insomnia reactivity in potentially stressful situations \[item scale 1 (not likely) - 4 (very likely)\]. The sum of the scores serves as the FIRST score.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	Sleep-related Beliefs and Attitudes about Sleep (DBAS-16) -questionnaire contains 16 items to assesses sleep-related dysfunctional cognitions \[item scale 0 (strongly disagree) - 10 (strongly agree)\]. The average of the scores serve as the DBAS score.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	The Epworth Sleepiness Scale (ESS) contains eight items to measure the subject's general level of daytime sleepiness in different situations \[item scale 0 (would never nod off) - 3 (high chance of nodding off)\]. The sum of the scores serves as the ESS score.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	The Patient Health Questionnaire (PHQ-9) contains nine items to measure depression severity \[item scale 0 (not at all) - 3 (nearly every day)\]. The sum of the scores serves as the PHQ-9 score.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	The GAD-7 contains seven items measuring the severity of the symptoms of generalised anxiety disorder \[item scale 0 (not at all) - 3 (nearly every day)\]. The sum of the scores serves as the GAD-7 score.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	The Burnout Assessment Tool (BAT-12) contains 12 items measuring burnout symptoms \[item scale 1 (never) - 5 (always)\]. The average of the scores serves as the BAT-12 score.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	EuroHIS-8 contains 8 items measuring the quality of life \[item scale 1 (worst outcome) - 5 (best outcome)\]. The sum of the scores serves as the EUROHIS-8 score.; Power, M. (2003). Development of a common instrument for quality of life. In A. Nosikov \& C. Gudex (edit.), EUROHIS: Developing Common Instruments for Health Surveys (145-159). Amsterdam, Holland: IOS Press.
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	Work ability measure includes an item measuring self-rated work ability (item scale 0 (not at all) - 10 (very good)\].
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.	From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.	The recovery measure includes an item measuring recovery from work \[item scale 1 (badly) - 5 (well)\]. In this study, recovery is measured separately in four different shifts (morning, day, evening and night shifts).

Trial Locations

Locations (4)

The Wellbeing Services County of South Ostrobotnia and TT Botnia Oy; 🇫🇮 Seinäjoki and Vaasa, Finland

Joint Authority HUS; 🇫🇮 Helsinki, Uusimaa, Finland

Finnish Institute of Occupational Health; 🇫🇮 Helsinki, Uusimaa, Finland

Terveystalo Oyj; 🇫🇮 Helsinki, Uusima, Finland