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

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ClinicalTrials.gov Identifier: NCT03322839
Recruitment Status : Completed
First Posted : October 26, 2017
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Lydia Kwak, Karolinska Institutet

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Common Mental Disorders Behavioral: Multifaceted implementation strategies Behavioral: Single implementation strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03322839


Locations
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Sweden
Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute
Stockholm, Sweden, 171 77
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Lydia Kwak, PhD Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lydia Kwak, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03322839    
Other Study ID Numbers: 150571
150571 ( Other Grant/Funding Number: AFA-insurance )
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The ethical approval does not allow data-sharing of individual participation data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lydia Kwak, Karolinska Institutet:
Guideline-adherence
Implementation
Implementation-strategies
Randomized-controlled-trial
Organisational risk-factors
Schools
Social risk-factors
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders