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

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ClinicalTrials.gov Identifier: NCT02523079
Recruitment Status : Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Finnish Work Environment Fund
NordForsk
City of Helsinki
City of Turku, Occupational Health Centre
Finnair Health Services
Aava Medical Centre
Fazer Health Services
Information provided by (Responsible Party):
Finnish Institute of Occupational Health

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.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Cognitive Behavioral Therapy Sleep Disorders, Circadian Rhythm Sleep Disorders, Shift-Work Behavioral: Cognitive Behavioral Group Therapy for Insomnia Behavioral: Cognitive Behavioral Self-help Therapy for Insomnia Behavioral: Sleep Hygiene Guidance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Cognitive Behavioral Group Therapy for Insomnia
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.
Behavioral: Cognitive Behavioral Group Therapy for Insomnia
Other Name: Group-based CBT-I

Experimental: Cognitive Behavioral Self-help Therapy for Insomnia
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.
Behavioral: Cognitive Behavioral Self-help Therapy for Insomnia
Other Name: Self-help CBT-I

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



Primary Outcome Measures :
  1. 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 Measures :
  1. Changes over the measurement points in sleep diary [ Time Frame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups ]
  2. Changes over the measurement points in Sleep Hygiene Practice Scale [ Time Frame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups ]
  3. Changes over the measurement points in actigraphy [ Time Frame: Baseline, immediately after intervention and 6-month follow-up ]
  4. 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 ]
  5. 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 ]
  6. Changes over the measurement points in Beck Depression Inventory [ Time Frame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Changes over the measurement points in Sense of Coherence [ Time Frame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups ]
  11. Changes over the measurement points in RAND SF-36 [ Time Frame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups ]
    Finnish version of the RAND 36 item Health Survey

  12. Changes over the measurement points in Work Ability Index [ Time Frame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups ]
  13. Changes over the measurement points in Own recovery evaluation [ Time Frame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups ]
  14. 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 ]
  15. Changes over the measurement points in computerized cognitive performance tests [ Time Frame: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups ]
  16. Changes over the measurement points in blood samples [ Time Frame: Baseline and 6-month follow-up ]
    Genetic analyses


Other Outcome Measures:
  1. Short Five (S5) Personality traits (NEO-PRI-R) [ Time Frame: Baseline ]
    Personality traits (Big Five facets)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523079


Locations
Layout table for location information
Finland
City of Helsinki, Occupational Health Centre
Helsinki, Uusimaa, Finland, 00099
Aava Medical Centre
Helsinki, Finland, 00240
Finnair Health Services
Helsinki, Finland, 01053
City of Turku, Occupational Health Centre
Turku, Finland, 20500
Fazer Health Services
Vantaa, Finland, 01230
Sponsors and Collaborators
Finnish Institute of Occupational Health
Finnish Work Environment Fund
NordForsk
City of Helsinki
City of Turku, Occupational Health Centre
Finnair Health Services
Aava Medical Centre
Fazer Health Services

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Finnish Institute of Occupational Health
ClinicalTrials.gov Identifier: NCT02523079    
Other Study ID Numbers: 34627
114391 ( Other Grant/Funding Number: Finnish Work Environment Fund )
53/13/03/00/15 ( Registry Identifier: The Ethics Committees of the Hospital District of Helsinki and Uusimaa, Finland )
74809 ( Other Grant/Funding Number: NordForsk )
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Disease
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Chronobiology Disorders
Occupational Diseases