## Protocol Section
### Identification Module
**NCT ID:** NCT02523079

**Acronym:** CBT-INSOMNIA

**Brief Title:** Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers

**Official Title:** Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers

#### Organization Study ID Info
**ID:** 34627
#### Organization
**Class:** OTHER
**Full Name:** Finnish Institute of Occupational Health
#### Secondary ID Infos
**Domain:** Finnish Work Environment Fund
**ID:** 114391
**Type:** OTHER_GRANT
**Domain:** The Ethics Committees of the Hospital District of Helsinki and Uusimaa, Finland
**ID:** 53/13/03/00/15
**Type:** REGISTRY
**Domain:** NordForsk
**ID:** 74809
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2020-06-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2019-04-16

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-15

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-01-01

**Type:** ACTUAL

**Status Verified Date:** 2019-04

#### Study First Post Date
**Date:** 2015-08-14
**Type:** ESTIMATED
**Study First Submit Date:** 2015-07-01
**Study First Submit QC Date:** 2015-08-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Finnish Work Environment Fund

**Class:** UNKNOWN

**Name:** NordForsk

**Class:** OTHER

**Name:** City of Helsinki

**Class:** UNKNOWN

**Name:** City of Turku, Occupational Health Centre

**Class:** UNKNOWN

**Name:** Finnair Health Services

**Class:** OTHER

**Name:** Aava Medical Centre

**Class:** UNKNOWN

**Name:** Fazer Health Services

#### Lead Sponsor

**Class:** OTHER

**Name:** Finnish Institute of Occupational Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Chronic Insomnia

- Cognitive Behavioral Therapy

- Sleep Disorders, Circadian Rhythm

- Sleep Disorders, Shift-Work

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 83

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: Cognitive Behavioral Group Therapy for Insomnia

**Label:** Cognitive Behavioral Group Therapy for Insomnia

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Intervention Names:**

- Behavioral: Cognitive Behavioral Self-help Therapy for Insomnia

**Label:** Cognitive Behavioral Self-help Therapy for Insomnia

**Type:** EXPERIMENTAL

#### Arm Group 3

**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 Names:**

- Behavioral: Sleep Hygiene Guidance

**Label:** Sleep Hygiene Guidance

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cognitive Behavioral Group Therapy for Insomnia

**Name:** Cognitive Behavioral Group Therapy for Insomnia

**Other Names:**

- Group-based CBT-I

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Cognitive Behavioral Self-help Therapy for Insomnia

**Name:** Cognitive Behavioral Self-help Therapy for Insomnia

**Other Names:**

- Self-help CBT-I

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Sleep Hygiene Guidance

**Name:** Sleep Hygiene Guidance

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Personality traits (Big Five facets)

**Measure:** Short Five (S5) Personality traits (NEO-PRI-R)

**Time Frame:** Baseline

#### Primary Outcomes

**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

#### Secondary Outcomes

**Measure:** Changes over the measurement points in sleep diary

**Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

**Measure:** Changes over the measurement points in Sleep Hygiene Practice Scale

**Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

**Measure:** Changes over the measurement points in actigraphy

**Time Frame:** Baseline, immediately after intervention and 6-month follow-up

**Measure:** 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

**Measure:** 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

**Measure:** Changes over the measurement points in Beck Depression Inventory

**Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** Changes over the measurement points in Sense of Coherence

**Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

**Description:** Finnish version of the RAND 36 item Health Survey

**Measure:** Changes over the measurement points in RAND SF-36

**Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

**Measure:** Changes over the measurement points in Work Ability Index

**Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

**Measure:** Changes over the measurement points in Own recovery evaluation

**Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

**Measure:** 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

**Measure:** Changes over the measurement points in computerized cognitive performance tests

**Time Frame:** Baseline, immediately after intervention and 6-, 12- and 24-month follow-ups

**Description:** Genetic analyses

**Measure:** Changes over the measurement points in blood samples

**Time Frame:** Baseline and 6-month follow-up

### Eligibility Module

**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)

**Maximum Age:** 60 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Helsinki

**Country:** Finland

**Facility:** City of Helsinki, Occupational Health Centre

**State:** Uusimaa

**Zip:** 00099

**Location 2:**

**City:** Helsinki

**Country:** Finland

**Facility:** Aava Medical Centre

**Zip:** 00240

**Location 3:**

**City:** Helsinki

**Country:** Finland

**Facility:** Finnair Health Services

**Zip:** 01053

**Location 4:**

**City:** Turku

**Country:** Finland

**Facility:** City of Turku, Occupational Health Centre

**Zip:** 20500

**Location 5:**

**City:** Vantaa

**Country:** Finland

**Facility:** Fazer Health Services

**Zip:** 01230

### References Module

#### References

**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;:

**PMID:** 31853633

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001523

- Term: Mental Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000021081

- Term: Chronobiology Disorders

- ID: D000009784

- Term: Occupational Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC24

- Name: Occupational Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M22007

- Name: Sleep Disorders, Circadian Rhythm

- Relevance: HIGH

- As Found: Sleep Disorders, Circadian Rhythm

- ID: M22242

- Name: Parasomnias

- Relevance: HIGH

- As Found: Sleep Disorders

- ID: M10356

- Name: Sleep Initiation and Maintenance Disorders

- Relevance: HIGH

- As Found: Insomnia

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: HIGH

- As Found: Sleep Disorders

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M22703

- Name: Chronobiology Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12719

- Name: Occupational Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007319

- Term: Sleep Initiation and Maintenance Disorders

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000020447

- Term: Parasomnias

- ID: D000020178

- Term: Sleep Disorders, Circadian Rhythm

### Misc Info Module

- Version Holder: 2024-05-24
