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

Finnish Institute of Occupational Health

Status: Unknown

Conditions: Sleep Disorders, Shift-Work; Chronic Insomnia; Sleep Disorders, Circadian Rhythm; Cognitive Behavioral Therapy

Treatments: Behavioral: Cognitive Behavioral Group Therapy for Insomnia; Behavioral: Cognitive Behavioral Self-help Therapy for Insomnia; Behavioral: Sleep Hygiene Guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT02523079

34627

114391 (Other Grant/Funding Number)

74809 (Other Grant/Funding Number)

53/13/03/00/15 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 3 patient groups

Cognitive Behavioral Group Therapy for Insomnia

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Group Therapy for Insomnia

Cognitive Behavioral Self-help Therapy for Insomnia

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Self-help Therapy for Insomnia

Sleep Hygiene Guidance

Experimental group

Description:

Includes one individual session (60 minutes) led by trained psychologist or nurse of occupational health services. The intervention is based on sleep hygiene guidance.

Treatment:

Behavioral: Sleep Hygiene Guidance