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

Common Mental Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322839
• Other study ID #: 150571
• Secondary ID: 150571
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 732
• Est. completion date: December 31, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Common Mental Disorders
• Mental Disorders
• Psychotic Disorders

Intervention

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.
• 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

Locations

Country	Name	City	State
Sweden	Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Guideline adherence (implementation effectiveness)	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
Primary	Exhaustion (intervention effectiveness)	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	Psychosocial safety climate	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
Secondary	Job demands	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
Secondary	Influence at work	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
Secondary	Social support colleagues	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
Secondary	Possibilities for development	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
Secondary	Commitment to the workplace	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
Secondary	Social support superior	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
Secondary	Work engagement	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
Secondary	Self-perceived health	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
Secondary	Self-reported stress	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
Secondary	Work-family conflict	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
Secondary	Recovery	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
Secondary	Work performance impairment due to health problems	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
Secondary	Work performance impairment due to problems in the work environment	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
Secondary	Self-reported sickness absenteeism	Change from baseline in self-reported sickness absenteeism as assessed by 2 items	At baseline and 6, 12 and 24 months after baseline
Secondary	Registered sickness absenteeism	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
Secondary	Recognition (reward)	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
Secondary	Self-reported stress (SMS)	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
Secondary	Process evaluation data	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.
Secondary	Process evaluation data	Process data will be collected over the 24 months. This data will be assessed by questionnaires	Assessed during the 24 month study period.
Secondary	Process evaluation data	Process data will be collected over the 24 months. This data will be assessed by observation	Assessed during the 24 month study period.
Secondary	Process evaluation data	Process data will be collected over the 24 months. This data will be assessed by documentation.	Assessed during the 24 month study period.
Secondary	Barriers	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
Secondary	Barriers	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
Secondary	Barriers	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
Secondary	Barriers	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
Secondary	Facilitators	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
Secondary	Facilitators	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
Secondary	Facilitators	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
Secondary	Facilitators	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