Evaluating the Effectiveness of Multifaceted Implementation Strategies for Implementing a Guideline for the Prevention of Common Mental Disorders at the Workplace in Schools

September 10, 2020 updated by: Lydia Kwak, Karolinska Institutet

Implementing the Swedish Guideline for the Prevention of Common Mental Disorders at the Workplace in Schools: Study Protocol of a Cluster Randomized Controlled Trial Using Multifaceted Implementation Strategies

Given today's high prevalence of common mental disorders and related sick leave among teachers an urgent need exists for a more sustainable working life for this professional group. One way of doing this is by improving schools' social and organizational risk management. Recent reports have shown that many schools in Sweden however lack a structured approach to the management of social and organizational risks. In 2015, we launched the first Swedish occupational health guideline to support a structured prevention of social and organizational risks at the workplace with the aim of preventing common mental disorders. The long-term goal of this study is to support the implementation of this guideline within schools in order to improve social and organizational risk management and in doing so reduce risk factors for mental ill-health and related sick days. The objective of the study is to fill the current research-to-practice gap by conducting a cluster-randomized controlled trial that compares the effectiveness of two implementation strategies for implementing the guideline in schools. The strategies that will be compared are training (ARM 1) versus training in combination with implementation teams and workshops (ARM 2). Our hypothesis for the study is that schools that receive support in implementing the guideline through combined strategies are more responsive to working in a structured and systematic manner with the management of social and organizational risks than schools that only receive training. The trial will be conducted in 20 primary schools in two municipalities in Sweden. All schools have agreed to participate. The primary outcomes are adherence to the guideline (implementation effectiveness) and self-reported exhaustion among schools personnel (intervention effectiveness); the secondary outcomes are risk factors for mental ill-health and absenteeism. Data will be collected at baseline, 6, 12 and 24 months by mixed methods (i.e. survey, focus-group interviews, observation, and register-data).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
732

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 77
        • Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all individuals who are employed by the participating schools

Exclusion Criteria:

  • individuals employed by the participating municipalities and not by the participating schools, for example cleaning personal. Individuals on sick-leave

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multifaceted implementation strategies
The school-management will participate in a one-day training. In addition each intervention school will form an implementation team that is responsible for the implementation of the guideline within their school. The implementation teams will participate in 4-5 workshops in order to support the implementation process.
Behavioral: Multifaceted implementation strategies
The school-management will participate in a one-day training aimed at providing knowledge and skills related the recommendations of the guideline for the prevention of common mental disorders at the workplace.In addition every intervention school will form an implementation team that is responsible for the implementation of the guideline. The implementation team will comprise of approximately 3-5 individuals with experience in the field of social and organizational work environment, for example school-management and occupational health and safety representative. The implementation teams will participate in 4-5 workshops aimed at supporting the implementation process. Intervention schools within the same municipality will participate in the same workshop in order to promote peer-support.
Active Comparator: Single implementation strategy
The control-schools will only receive training to the school-management.
Behavioral: Single implementation strategy
The school-management will participate in a one-day training aimed at providing knowledge and skills related to the recommendations of the guideline for the prevention of common mental disorders at the workplace

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Guideline adherence (implementation effectiveness)
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in adherence to the recommendations of the guideline during 6, 12 and 24 months follow-up period. We will use a questionnaire directed at the school management and a questionnaire directed at the school personnel. The questionnaires contain statements related to the recommendations in the guideline, such as "at our school we have clear and practical policies for preventing mental ill-health among our employees".
At baseline and 6, 12 and 24 months after baseline
Exhaustion (intervention effectiveness)
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in personnel's self-reported exhaustion during 6, 12 and 24 months follow. We hypothesize that adherence to the recommendations of the guideline will affect school personnel's self-reported exhaustion assessed with the Oldenburg Burnout Inventory (response format 1-4).
At baseline and 6, 12 and 24 months after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychosocial safety climate
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported psychosocial safety climate as assessed by the 11-items of the Psychosocial Safety Climate Scale (response format 1-5)
At baseline and 6, 12 and 24 months after baseline
Job demands
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported job-demands as assessed by 11 items of the Copenhagen Psychosocial Questionnaire (response form 1-5)
At baseline and 6, 12 and 24 months after baseline
Influence at work
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported influence at work as assessed by 4 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
At baseline and 6, 12 and 24 months after baseline
Social support colleagues
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported social support as assessed by 3 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
At baseline and 6, 12 and 24 months after baseline
Possibilities for development
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported possibilities for development as assessed by 4 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
At baseline and 6, 12 and 24 months after baseline
Commitment to the workplace
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported commitment as assessed by 3 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
At baseline and 6, 12 and 24 months after baseline
Social support superior
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported social support from superior as assessed by 3 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
At baseline and 6, 12 and 24 months after baseline
Work engagement
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported engagement as assessed by 3 items of the Utrecht Work Engagement Scale (response-form 1-7)
At baseline and 6, 12 and 24 months after baseline
Self-perceived health
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-perceived health as assessed with a single question (response-form 1-5)
At baseline and 6, 12 and 24 months after baseline
Self-reported stress
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported stress as assessed with a single question (response-form 1-5)
At baseline and 6, 12 and 24 months after baseline
Work-family conflict
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported work-family conflict as assessed with 4 items of the Copenhagen Psychosocial Questionnaire (response-form 1-4)
At baseline and 6, 12 and 24 months after baseline
Recovery
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported recovery as assessed with 1 item (response-form 1-5)
At baseline and 6, 12 and 24 months after baseline
Work performance impairment due to health problems
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in work performance as assessed by a question based on one item from the Work productivity Activity impairment - General Health Questionnaire (response format 0-10)
At baseline and 6, 12 and 24 months after baseline
Work performance impairment due to problems in the work environment
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in work performance as assessed by a question based on one item from the Work Productivity Activity Impairment - General Health Questionnaire (response format from 0-10)
At baseline and 6, 12 and 24 months after baseline
Self-reported sickness absenteeism
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline in self-reported sickness absenteeism as assessed by 2 items
At baseline and 6, 12 and 24 months after baseline
Registered sickness absenteeism
Time Frame: 12 months prior to baseline, and during 24 months after baseline
Change in total sick-leave due to common mental disorders in days, register data (sickness benefit and disability pension).
12 months prior to baseline, and during 24 months after baseline
Recognition (reward)
Time Frame: At baseline and 6, 12 and 24 months after baseline
Change from baseline self-reported collaboration and leadership as assessed by 3-items of Copenhagen Psychosocial Questionnaire (response-format 1-5)
At baseline and 6, 12 and 24 months after baseline
Self-reported stress (SMS)
Time Frame: Measured every 4th week over 12 months from baseline
Change from baseline in self-reported stress as assessed by one item sent by text-message by mobile-phone
Measured every 4th week over 12 months from baseline
Process evaluation data
Time Frame: Assessed during the 24 month study period.
Process data will be collected over the 24 months. This data will be assessed by focus-group interviews.
Assessed during the 24 month study period.
Process evaluation data
Time Frame: Assessed during the 24 month study period.
Process data will be collected over the 24 months. This data will be assessed by questionnaires
Assessed during the 24 month study period.
Process evaluation data
Time Frame: Assessed during the 24 month study period.
Process data will be collected over the 24 months. This data will be assessed by observation
Assessed during the 24 month study period.
Process evaluation data
Time Frame: Assessed during the 24 month study period.
Process data will be collected over the 24 months. This data will be assessed by documentation.
Assessed during the 24 month study period.
Barriers
Time Frame: Assessed during the 24 month study period
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by focus-group interviews
Assessed during the 24 month study period
Barriers
Time Frame: Assessed during the 24 month study period
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by questionnaires
Assessed during the 24 month study period
Barriers
Time Frame: Assessed during the 24 month study period
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by observation
Assessed during the 24 month study period
Barriers
Time Frame: Assessed during the 24 month study period
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by documentation.
Assessed during the 24 month study period
Facilitators
Time Frame: Assessed during the 24 month study period
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by focus-group interviews
Assessed during the 24 month study period
Facilitators
Time Frame: Assessed during the 24 month study period
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by questionnaires
Assessed during the 24 month study period
Facilitators
Time Frame: Assessed during the 24 month study period
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by observation
Assessed during the 24 month study period
Facilitators
Time Frame: Assessed during the 24 month study period
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by documentation.
Assessed during the 24 month study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 150571 (Other Grant/Funding Number: AFA-insurance)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The ethical approval does not allow data-sharing of individual participation data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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