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

NCT06827626 | Active Not Recruiting DMC

• 1 other identifier: 4025601
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

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.

Conditions

Shift Work Sleep Disorder; Insomnia Chronic

Keywords

Shift work; Insomnia; Shift work sleep disorder; CBT-I; Occupational Health Services

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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 (12)

• 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.

• 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.

• 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.

• 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.

• 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.

Other Outcomes (4)

• Implementation experiences of the interventions

  After the end of treatment (12 weeks after the first session)

• Global effectiveness of the treatment

  After the end of treatment (12 weeks after the first session)

• Demographic and background information about participants´ work and health

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

Study Arms (2)

Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

Cognitive-Behavioural Therapy for Insomnia (CBT-I) is tailored for shift workers in social and health care sector. CBT-I is delivered individually (six sessions) by trained nurses. It includes behavioral methods (sleep compression tailored for shift work context), cognitive methods, and shift work related sleep hygiene counselling.

Behavioral: Cognitive behavioral therapy for insomnia

Sleep hygiene counselling

ACTIVE COMPARATOR

Sleep hygiene counselling is delivered individually (one session) by trained nurses. It includes sleep hygiene instructions tailored to the context of shift work.

Behavioral: Sleep hygiene counselling

Interventions

Sleep hygiene counselling BEHAVIORAL

Sleep hygiene counselling includes common instructions to improve sleep.

Also known as: Sleep hygiene

Sleep hygiene counselling

Cognitive behavioral therapy for insomnia BEHAVIORAL

Cognitive-Behavioural Therapy for Insomnia (CBT-I) includes behavioral methods, cognitive methods, and sleep hygiene counselling.

Also known as: CBT-I

Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 years
• working in social and heath care sector
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Joint Authority HUS: collaborator
• Finnish Institute of Occupational Health: lead
• Finnish Work Environment Fund: collaborator
• Terveystalo Oyj: collaborator
• The Wellbeing Services County of South Ostrobotnia and TT Botnia Oy: collaborator

Study Sites (4)

Joint Authority HUS

Helsinki, Uusimaa, FI-00029, Finland

Location

Finnish Institute of Occupational Health

Helsinki, Uusimaa, FI-00032, Finland

Location

Terveystalo Oyj

Helsinki, Uusima, FI-00100, Finland

Location

The Wellbeing Services County of South Ostrobotnia and TT Botnia Oy

Seinäjoki, Finland

Location

Related Publications (12)

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• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

  PMID: 21532953 RESULT

Related Links

• Project web page

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Circadian Rhythm

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Chronobiology Disorders; Occupational Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 14, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (4)