Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers

Chronic Insomnia Clinical Trial

— CBT-INSOMNIA  

Official title:

Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02523079
• Other study ID #: 34627
• Secondary ID: 11439153/13/03/0
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2019
• Source: Finnish Institute of Occupational Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Insomnia
• Cognitive Behavioral Therapy
• Disease
• Parasomnias
• Sleep Disorders, Circadian Rhythm
• Sleep Disorders, Shift-Work
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Behavioral:
• Cognitive Behavioral Group Therapy for Insomnia

• Cognitive Behavioral Self-help Therapy for Insomnia

• Sleep Hygiene Guidance

Locations

Country	Name	City	State
Finland	Aava Medical Centre	Helsinki
Finland	City of Helsinki, Occupational Health Centre	Helsinki	Uusimaa
Finland	Finnair Health Services	Helsinki
Finland	City of Turku, Occupational Health Centre	Turku
Finland	Fazer Health Services	Vantaa

Sponsors (8)

Lead Sponsor	Collaborator
Finnish Institute of Occupational Health	Aava Medical Centre, City of Helsinki, City of Turku, Occupational Health Centre, Fazer Health Services, Finnair Health Services, Finnish Work Environment Fund, NordForsk

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short Five (S5) Personality traits (NEO-PRI-R)	Personality traits (Big Five facets)	Baseline
Primary	Changes over the measurement points in Insomnia Severity Index (ISI)		Baseline, immediately after intervention and 3-, 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in sleep diary		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in Sleep Hygiene Practice Scale		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in actigraphy		Baseline, immediately after intervention and 6-month follow-up
Secondary	Changes over the measurement points in Shirom-Melamed Burnout Measure (SMBM)		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in Generalized Anxiety Disorder (GAD-7)		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in Beck Depression Inventory		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	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
Secondary	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
Secondary	Changes over the measurement points in Penn State Worry Questionnaire (PSWQ)		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in Sense of Coherence		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	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
Secondary	Changes over the measurement points in Work Ability Index		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in Own recovery evaluation		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in Work Cognitive Failure Scale (WCFS)		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in computerized cognitive performance tests		Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Secondary	Changes over the measurement points in blood samples	Genetic analyses	Baseline and 6-month follow-up