Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers
CBT-INSOMNIA
4 other identifiers
interventional
83
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedApril 16, 2019
April 1, 2019
5 years
July 1, 2015
April 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Changes over the measurement points in Insomnia Severity Index (ISI)
Baseline, immediately after intervention and 3-, 6-, 12- and 24-month follow-ups
Secondary Outcomes (16)
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
- +11 more secondary outcomes
Other Outcomes (1)
Short Five (S5) Personality traits (NEO-PRI-R)
Baseline
Study Arms (3)
Cognitive Behavioral Group Therapy for Insomnia
EXPERIMENTALIncludes 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.
Cognitive Behavioral Self-help Therapy for Insomnia
EXPERIMENTALMainly 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.
Sleep Hygiene Guidance
EXPERIMENTALIncludes one individual session (60 minutes) led by trained psychologist or nurse of occupational health services. The intervention is based on sleep hygiene guidance.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Non-assessed or untreated somatic or mental illness which may explain insomnia
- Planned changes in the work (for example retirement)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finnish Institute of Occupational Healthlead
- Finnish Work Environment Fundcollaborator
- NordForskcollaborator
- City of Helsinkicollaborator
- City of Turku, Occupational Health Centrecollaborator
- Finnair Health Servicescollaborator
- Aava Medical Centrecollaborator
- Fazer Health Servicescollaborator
Study Sites (5)
City of Helsinki, Occupational Health Centre
Helsinki, Uusimaa, 00099, Finland
Aava Medical Centre
Helsinki, 00240, Finland
Finnair Health Services
Helsinki, 01053, Finland
City of Turku, Occupational Health Centre
Turku, 20500, Finland
Fazer Health Services
Vantaa, 01230, Finland
Related Publications (1)
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.
PMID: 31853633DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2015
First Posted
August 14, 2015
Study Start
January 1, 2015
Primary Completion
December 31, 2019
Study Completion
June 30, 2020
Last Updated
April 16, 2019
Record last verified: 2019-04