Clinical trial NCT02523079: Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers
Official title: Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Insomnia
Cognitive Behavioral Therapy
Sleep Disorders, Circadian Rhythm
Sleep Disorders, Shift-Work
Lead sponsor: Finnish Institute of Occupational Health
Sponsor class: OTHER
Collaborators: name: Finnish Work Environment Fund
name: NordForsk
name: City of Helsinki
name: City of Turku, Occupational Health Centre
name: Finnair Health Services
name: Aava Medical Centre
name: Fazer Health Services
First posted: 2015-08-14
Enrollment: 83
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes over the measurement points in Insomnia Severity Index (ISI)
timeFrame: Baseline, immediately after intervention and 3-, 6-, 12- and 24-month follow-ups
Secondary outcomes:
measure: Changes over the measurement points in sleep diary
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in Sleep Hygiene Practice Scale
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in actigraphy
timeFrame: Baseline, immediately after intervention and 6-month follow-up
measure: Changes over the measurement points in Shirom-Melamed Burnout Measure (SMBM)
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in Beck Depression Inventory
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in a single-item measure of stress symptoms
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in Penn State Worry Questionnaire (PSWQ)
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in Sense of Coherence
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in RAND SF-36
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in Work Ability Index
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in Own recovery evaluation
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in Work Cognitive Failure Scale (WCFS)
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in computerized cognitive performance tests
timeFrame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
measure: Changes over the measurement points in blood samples
timeFrame: Baseline and 6-month follow-up
Other outcomes:
measure: Short Five (S5) Personality traits (NEO-PRI-R)
timeFrame: Baseline
Locations:
city: Helsinki
country: Finland
facility: City of Helsinki, Occupational Health Centre
state: Uusimaa
city: Helsinki
country: Finland
facility: Aava Medical Centre
city: Helsinki
country: Finland
facility: Finnair Health Services
city: Turku
country: Finland
facility: City of Turku, Occupational Health Centre
city: Vantaa
country: Finland
facility: Fazer Health Services
Study officials:
References:
citation: 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.