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

Primary Purpose

Chronic Insomnia, Cognitive Behavioral Therapy, Sleep Disorders, Circadian Rhythm

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Cognitive Behavioral Group Therapy for Insomnia
Cognitive Behavioral Self-help Therapy for Insomnia
Sleep Hygiene Guidance
Sponsored by
Finnish Institute of Occupational Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • City of Helsinki, Occupational Health Centre
  • Aava Medical Centre
  • Finnair Health Services
  • City of Turku, Occupational Health Centre
  • Fazer Health Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cognitive Behavioral Group Therapy for Insomnia

Cognitive Behavioral Self-help Therapy for Insomnia

Sleep Hygiene Guidance

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Changes over the measurement points in Insomnia Severity Index (ISI)

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2015
Last Updated
April 15, 2019
Sponsor
Finnish Institute of Occupational Health
Collaborators
Finnish Work Environment Fund, NordForsk, City of Helsinki, City of Turku, Occupational Health Centre, Finnair Health Services, Aava Medical Centre, Fazer Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT02523079
Brief Title
Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers
Acronym
CBT-INSOMNIA
Official Title
Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Finnish Institute of Occupational Health
Collaborators
Finnish Work Environment Fund, NordForsk, City of Helsinki, City of Turku, Occupational Health Centre, Finnair Health Services, Aava Medical Centre, Fazer Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia, Cognitive Behavioral Therapy, Sleep Disorders, Circadian Rhythm, Sleep Disorders, Shift-Work

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Group Therapy for Insomnia
Arm Type
Experimental
Arm 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.
Arm Title
Cognitive Behavioral Self-help Therapy for Insomnia
Arm Type
Experimental
Arm 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.
Arm Title
Sleep Hygiene Guidance
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Group Therapy for Insomnia
Other Intervention Name(s)
Group-based CBT-I
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Self-help Therapy for Insomnia
Other Intervention Name(s)
Self-help CBT-I
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Guidance
Primary Outcome Measure Information:
Title
Changes over the measurement points in Insomnia Severity Index (ISI)
Time Frame
Baseline, immediately after intervention and 3-, 6-, 12- and 24-month follow-ups
Secondary Outcome Measure Information:
Title
Changes over the measurement points in sleep diary
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in Sleep Hygiene Practice Scale
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in actigraphy
Time Frame
Baseline, immediately after intervention and 6-month follow-up
Title
Changes over the measurement points in Shirom-Melamed Burnout Measure (SMBM)
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in Generalized Anxiety Disorder (GAD-7)
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in Beck Depression Inventory
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in a single-item measure of stress symptoms
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in Penn State Worry Questionnaire (PSWQ)
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in Sense of Coherence
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in RAND SF-36
Description
Finnish version of the RAND 36 item Health Survey
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in Work Ability Index
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in Own recovery evaluation
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in Work Cognitive Failure Scale (WCFS)
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in computerized cognitive performance tests
Time Frame
Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups
Title
Changes over the measurement points in blood samples
Description
Genetic analyses
Time Frame
Baseline and 6-month follow-up
Other Pre-specified Outcome Measures:
Title
Short Five (S5) Personality traits (NEO-PRI-R)
Description
Personality traits (Big Five facets)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
City of Helsinki, Occupational Health Centre
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00099
Country
Finland
Facility Name
Aava Medical Centre
City
Helsinki
ZIP/Postal Code
00240
Country
Finland
Facility Name
Finnair Health Services
City
Helsinki
ZIP/Postal Code
01053
Country
Finland
Facility Name
City of Turku, Occupational Health Centre
City
Turku
ZIP/Postal Code
20500
Country
Finland
Facility Name
Fazer Health Services
City
Vantaa
ZIP/Postal Code
01230
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31853633
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. Erratum In: Int Arch Occup Environ Health. 2020 Mar 3;:
Results Reference
derived

Learn more about this trial

Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers

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