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Completed

NCT Number: NCT03322839

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

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).

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Key information

Conditions

Common Mental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute

Stockholm, 171 77, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifaceted implementation strategies

Behavioral

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.

Single implementation strategy

Behavioral

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

Primary outcomes

  1. 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".

  2. 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).

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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

  16. 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).

  17. 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)

  18. 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

  19. 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.

  20. 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

  21. 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

  22. 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.

  23. 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

  24. 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

  25. 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

  26. 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.

  27. 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

  28. 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

  29. 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

  30. 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2017
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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