Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers (CBT-INSOMNIA)

The aim of the study is to compare the implementation and effectiveness of group and self-help based cognitive behavioral treatment for insomnia (CBT-I) delivered by occupational health services (OHS) in a randomized and controlled design (RCT) among different types of shift workers.

Study Overview

• Status: Unknown
• Conditions: Chronic Insomnia; Sleep Disorders, Circadian Rhythm; Cognitive Behavioral Therapy; Sleep Disorders, Shift-Work
• Intervention / Treatment: Behavioral: Cognitive Behavioral Group Therapy for Insomnia; Behavioral: Cognitive Behavioral Self-help Therapy for Insomnia; Behavioral: Sleep Hygiene Guidance

Detailed Description

Because of irregular sleep-wake pattern shift work is a challenge in the screening and treatment of chronic insomnia. Earlier results has showed that CBT-I delivered by trained nurses of OHS may be effective treatment also among workers with irregular work hours. The aim of the present study is to compare the implementation and effectiveness of OHS delivered group and self-help based CBT-I in a RCT design among different types of shift work.

Participants (n=90-120) are shift workers with insomnia disorder that has lasted at least three months. The participants are randomized to a) group-based CBT-I (6 group sessions); or b) mainly computerized self-help CBT-I (an individual session before and after the intervention) delivered by a trained OHS nurse or psychologist; or c) control group given a sleep hygiene intervention (1 individual session). Outcomes are assessed using a sleep diary, questionnaires, actigraphy and cognitive performance tests. To study the effect of CBT-I program at molecular level, blood samples of participants will be collected at baseline and at the end of the program for genetic analyses. The measurements are conducted at five time points for a period of two years.

The investigators expect to find that both group and self-help based CBT-I among different types of shift workers are effective low-intensity treatments of chronic insomnia compared to control intervention.

Through the training of OHS or general medical practitioners and by computerised self-help interventions the investigators may have better chance to make CBT-I more accessible to a larger number of insomniacs also with different types of working hours. Additionally, it may be possible to decrease chronic insomnia and unfavourably consequences of insomnia to the health and performance capacity in shift workers.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00240
    • Aava Medical Centre
  • Helsinki, Finland, 01053
    • Finnair Health Services
  • Turku, Finland, 20500
    • City of Turku, Occupational Health Centre
  • Vantaa, Finland, 01230
    • Fazer Health Services
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00099
      • City of Helsinki, Occupational Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic Insomnia (F51.0)
• Difficulty initiating and/or maintaining sleep for ≥ 30 minutes and/or the use of sleep promoting medicine on three or more nights per week for at least 3 months
• Motivation to treat insomnia with non-pharmacological methods
• Full-time shift work (at least 10 % of shifts are morning, evening and/or night shifts)
• Fluent Finnish (due to interventions)

Exclusion Criteria:

• Non-assessed or untreated somatic or mental illness which may explain insomnia
• Planned changes in the work (for example retirement)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Group Therapy for Insomnia; Includes 6 group sessions (90 minutes each). The groups are led by trained psychologist or nurse of occupational health services. The manualized treatment is based on the general CBT-I model and includes components such as sleep hygiene, relaxation, stimulus control, sleep restriction and cognitive restructuring. In addition, participants receive information on how to schedule sleep, wake and light based on circadian principles while working differently timed shifts.	Behavioral: Cognitive Behavioral Group Therapy for Insomnia; Other Names: Group-based CBT-I
Experimental: Cognitive Behavioral Self-help Therapy for Insomnia; Mainly computerized self-help intervention. Includes an individual session before and after the intervention (30 minutes each) led by trained psychologist or nurse of occupational health services. The self-help treatment is based on the general CBT-I model and includes components such as sleep hygiene, relaxation, stimulus control, sleep restriction and cognitive restructuring. In addition, participants receive information on how to schedule sleep, wake and light based on circadian principles while working differently timed shifts.	Behavioral: Cognitive Behavioral Self-help Therapy for Insomnia; Other Names: Self-help CBT-I
Experimental: Sleep Hygiene Guidance; Includes one individual session (60 minutes) led by trained psychologist or nurse of occupational health services. The intervention is based on sleep hygiene guidance.	Behavioral: Sleep Hygiene Guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes over the measurement points in Insomnia Severity Index (ISI)	Baseline, immediately after intervention and 3-, 6-, 12- and 24-month follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes over the measurement points in sleep diary		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in Sleep Hygiene Practice Scale		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in actigraphy		Baseline, immediately after intervention and 6-month follow-up
Changes over the measurement points in Shirom-Melamed Burnout Measure (SMBM)		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in Generalized Anxiety Disorder (GAD-7)		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in Beck Depression Inventory		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in a single-item measure of stress symptoms		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in Penn State Worry Questionnaire (PSWQ)		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in Sense of Coherence		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in RAND SF-36	Finnish version of the RAND 36 item Health Survey	Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in Work Ability Index		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in Own recovery evaluation		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in Work Cognitive Failure Scale (WCFS)		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in computerized cognitive performance tests		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Changes over the measurement points in blood samples	Genetic analyses	Baseline and 6-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Five (S5) Personality traits (NEO-PRI-R)	Personality traits (Big Five facets)	Baseline

Collaborators and Investigators

• Sponsor: Finnish Institute of Occupational Health
• Collaborators: City of Helsinki; Finnish Work Environment Fund; NordForsk; City of Turku, Occupational Health Centre; Finnair Health Services; Aava Medical Centre; Fazer Health Services

Publications and helpful links

General Publications

• Jarnefelt H, Harma M, Sallinen M, Virkkala J, Paajanen T, Martimo KP, Hublin C. Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting. Int Arch Occup Environ Health. 2020 Jul;93(5):535-550. doi: 10.1007/s00420-019-01504-6. Epub 2019 Dec 18. Erratum In: Int Arch Occup Environ Health. 2020 Mar 3;:

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Disease; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Parasomnias; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 34627; 114391 (Other Grant/Funding Number: Finnish Work Environment Fund); 53/13/03/00/15 (Registry Identifier: The Ethics Committees of the Hospital District of Helsinki and Uusimaa, Finland); 74809 (Other Grant/Funding Number: NordForsk)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No