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Chronic InsomniaCBT-INSOMNIANCT02523079

Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers

A study testing Cognitive Behavioral Group Therapy for Insomnia, Cognitive Behavioral Self-help Therapy for Insomnia and Sleep Hygiene Guidance in people with Chronic Insomnia and Cognitive Behavioral Therapy, run by Finnish Institute of Occupational Health at 5 sites in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 60 years
What is being tested?
Cognitive Behavioral Group Therapy for Insomnia, Cognitive Behavioral Self-help Therapy for Insomnia and Sleep Hygiene Guidance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
5 sitesFinland
Study dates
1 Jan 2015to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • Non-assessed or untreated somatic or mental illness which may explain insomnia
  • Planned changes in the work (for example retirement)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Finland5 sites

  • City of Helsinki, Occupational Health Centre

    Helsinki, Uusimaa, 00099

  • Aava Medical Centre

    Helsinki, 00240

  • Finnair Health Services

    Helsinki, 01053

  • City of Turku, Occupational Health Centre

    Turku, 20500

  • Fazer Health Services

    Vantaa, 01230

Other trials in Finland

About this study

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.

Read the 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.

Being tested
Cognitive Behavioral Group Therapy for Insomnia, Cognitive Behavioral Self-help Therapy for Insomnia, Sleep Hygiene Guidance
Medical subject headings
Sleep Initiation and Maintenance Disorders, Sleep Disorders, Circadian Rhythm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Group Therapy for InsomniaBehavioural

    Also called Group-based CBT-I

  • Cognitive Behavioral Self-help Therapy for InsomniaBehavioural

    Also called Self-help CBT-I

  • Sleep Hygiene GuidanceBehavioural

Study groups in NCT02523079
Study groupRoleWhat they receive
Cognitive Behavioral Group Therapy for InsomniaExperimentalIncludes 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.
Receives: Behavioral: Cognitive Behavioral Group Therapy for Insomnia
Cognitive Behavioral Self-help Therapy for InsomniaExperimentalMainly 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.
Receives: Behavioral: Cognitive Behavioral Self-help Therapy for Insomnia
Sleep Hygiene GuidanceExperimentalIncludes one individual session (60 minutes) led by trained psychologist or nurse of occupational health services. The intervention is based on sleep hygiene guidance.
Receives: Behavioral: Sleep Hygiene Guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, immediately after intervention and 3-, 6-, 12- and 24-month follow-ups

Secondary outcomes (16)

  1. Changes over the measurement points in sleep diary

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  2. Changes over the measurement points in Sleep Hygiene Practice Scale

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  3. Changes over the measurement points in actigraphy

    Measured: Baseline, immediately after intervention and 6-month follow-up

  4. Changes over the measurement points in Shirom-Melamed Burnout Measure (SMBM)

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  5. Changes over the measurement points in Generalized Anxiety Disorder (GAD-7)

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  6. Changes over the measurement points in Beck Depression Inventory

    Measured: 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

    Measured: 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)

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  9. Changes over the measurement points in Penn State Worry Questionnaire (PSWQ)

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  10. Changes over the measurement points in Sense of Coherence

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  11. Changes over the measurement points in RAND SF-36

    Finnish version of the RAND 36 item Health Survey

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  12. Changes over the measurement points in Work Ability Index

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  13. Changes over the measurement points in Own recovery evaluation

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  14. Changes over the measurement points in Work Cognitive Failure Scale (WCFS)

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  15. Changes over the measurement points in computerized cognitive performance tests

    Measured: Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

  16. Changes over the measurement points in blood samples

    Genetic analyses

    Measured: Baseline and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2015 (estimated)
  2. Study start1 Jan 2015
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02523079
Sponsor's protocol ID
34627
Other IDs
114391, 53/13/03/00/15, 74809
Acronym
CBT-INSOMNIA
Status last verified
Apr 2019
First submitted
1 Jul 2015
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31853633

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Group Therapy for Insomnia, Cognitive Behavioral Self-help Therapy for Insomnia and Sleep Hygiene Guidance in people with Chronic Insomnia and Cognitive Behavioral Therapy, run by Finnish Institute of Occupational Health at 5 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02523079, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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