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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

Primary Purpose

Common Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Multifaceted implementation strategies
Single implementation strategy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Common Mental Disorders focused on measuring Guideline-adherence, Implementation, Implementation-strategies, Randomized-controlled-trial, Organisational risk-factors, Schools, Social risk-factors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multifaceted implementation strategies

Single implementation strategy

Arm Description

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.

The control-schools will only receive training to the school-management.

Outcomes

Primary Outcome Measures

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".
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).

Secondary Outcome Measures

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)
Job demands
Change from baseline in self-reported job-demands as assessed by 11 items of the Copenhagen Psychosocial Questionnaire (response form 1-5)
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)
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)
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)
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)
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)
Work engagement
Change from baseline in self-reported engagement as assessed by 3 items of the Utrecht Work Engagement Scale (response-form 1-7)
Self-perceived health
Change from baseline in self-perceived health as assessed with a single question (response-form 1-5)
Self-reported stress
Change from baseline in self-reported stress as assessed with a single question (response-form 1-5)
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)
Recovery
Change from baseline in self-reported recovery as assessed with 1 item (response-form 1-5)
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)
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)
Self-reported sickness absenteeism
Change from baseline in self-reported sickness absenteeism as assessed by 2 items
Registered sickness absenteeism
Change in total sick-leave due to common mental disorders in days, register data (sickness benefit and disability pension).
Recognition (reward)
Change from baseline self-reported collaboration and leadership as assessed by 3-items of Copenhagen Psychosocial Questionnaire (response-format 1-5)
Self-reported stress (SMS)
Change from baseline in self-reported stress as assessed by one item sent by text-message by mobile-phone
Process evaluation data
Process data will be collected over the 24 months. This data will be assessed by focus-group interviews.
Process evaluation data
Process data will be collected over the 24 months. This data will be assessed by questionnaires
Process evaluation data
Process data will be collected over the 24 months. This data will be assessed by observation
Process evaluation data
Process data will be collected over the 24 months. This data will be assessed by documentation.
Barriers
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by focus-group interviews
Barriers
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by questionnaires
Barriers
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by observation
Barriers
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by documentation.
Facilitators
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by focus-group interviews
Facilitators
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by questionnaires
Facilitators
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by observation
Facilitators
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by documentation.

Full Information

First Posted
September 19, 2017
Last Updated
September 10, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03322839
Brief Title
Evaluating the Effectiveness of Multifaceted Implementation Strategies for Implementing a Guideline for the Prevention of Common Mental Disorders at the Workplace in Schools
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Mental Disorders
Keywords
Guideline-adherence, Implementation, Implementation-strategies, Randomized-controlled-trial, Organisational risk-factors, Schools, Social risk-factors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
732 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifaceted implementation strategies
Arm Type
Experimental
Arm Description
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.
Arm Title
Single implementation strategy
Arm Type
Active Comparator
Arm Description
The control-schools will only receive training to the school-management.
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted implementation strategies
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Single implementation strategy
Intervention Description
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 Measure Information:
Title
Guideline adherence (implementation effectiveness)
Description
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".
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Exhaustion (intervention effectiveness)
Description
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).
Time Frame
At baseline and 6, 12 and 24 months after baseline
Secondary Outcome Measure Information:
Title
Psychosocial safety climate
Description
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)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Job demands
Description
Change from baseline in self-reported job-demands as assessed by 11 items of the Copenhagen Psychosocial Questionnaire (response form 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Influence at work
Description
Change from baseline in self-reported influence at work as assessed by 4 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Social support colleagues
Description
Change from baseline in self-reported social support as assessed by 3 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Possibilities for development
Description
Change from baseline in self-reported possibilities for development as assessed by 4 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Commitment to the workplace
Description
Change from baseline in self-reported commitment as assessed by 3 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Social support superior
Description
Change from baseline in self-reported social support from superior as assessed by 3 items of the Copenhagen Psychosocial Questionnaire (response-form 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Work engagement
Description
Change from baseline in self-reported engagement as assessed by 3 items of the Utrecht Work Engagement Scale (response-form 1-7)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Self-perceived health
Description
Change from baseline in self-perceived health as assessed with a single question (response-form 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Self-reported stress
Description
Change from baseline in self-reported stress as assessed with a single question (response-form 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Work-family conflict
Description
Change from baseline in self-reported work-family conflict as assessed with 4 items of the Copenhagen Psychosocial Questionnaire (response-form 1-4)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Recovery
Description
Change from baseline in self-reported recovery as assessed with 1 item (response-form 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Work performance impairment due to health problems
Description
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)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Work performance impairment due to problems in the work environment
Description
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)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Self-reported sickness absenteeism
Description
Change from baseline in self-reported sickness absenteeism as assessed by 2 items
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Registered sickness absenteeism
Description
Change in total sick-leave due to common mental disorders in days, register data (sickness benefit and disability pension).
Time Frame
12 months prior to baseline, and during 24 months after baseline
Title
Recognition (reward)
Description
Change from baseline self-reported collaboration and leadership as assessed by 3-items of Copenhagen Psychosocial Questionnaire (response-format 1-5)
Time Frame
At baseline and 6, 12 and 24 months after baseline
Title
Self-reported stress (SMS)
Description
Change from baseline in self-reported stress as assessed by one item sent by text-message by mobile-phone
Time Frame
Measured every 4th week over 12 months from baseline
Title
Process evaluation data
Description
Process data will be collected over the 24 months. This data will be assessed by focus-group interviews.
Time Frame
Assessed during the 24 month study period.
Title
Process evaluation data
Description
Process data will be collected over the 24 months. This data will be assessed by questionnaires
Time Frame
Assessed during the 24 month study period.
Title
Process evaluation data
Description
Process data will be collected over the 24 months. This data will be assessed by observation
Time Frame
Assessed during the 24 month study period.
Title
Process evaluation data
Description
Process data will be collected over the 24 months. This data will be assessed by documentation.
Time Frame
Assessed during the 24 month study period.
Title
Barriers
Description
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by focus-group interviews
Time Frame
Assessed during the 24 month study period
Title
Barriers
Description
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by questionnaires
Time Frame
Assessed during the 24 month study period
Title
Barriers
Description
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by observation
Time Frame
Assessed during the 24 month study period
Title
Barriers
Description
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by documentation.
Time Frame
Assessed during the 24 month study period
Title
Facilitators
Description
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by focus-group interviews
Time Frame
Assessed during the 24 month study period
Title
Facilitators
Description
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by questionnaires
Time Frame
Assessed during the 24 month study period
Title
Facilitators
Description
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by observation
Time Frame
Assessed during the 24 month study period
Title
Facilitators
Description
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by documentation.
Time Frame
Assessed during the 24 month study period

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia Kwak, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The ethical approval does not allow data-sharing of individual participation data.
Citations:
PubMed Identifier
31829186
Citation
Kwak L, Lornudd C, Bjorklund C, Bergstrom G, Nybergh L, Elinder LS, Stigmar K, Wahlin C, Jensen I. Implementation of the Swedish Guideline for Prevention of Mental ill-health at the Workplace: study protocol of a cluster randomized controlled trial, using multifaceted implementation strategies in schools. BMC Public Health. 2019 Dec 11;19(1):1668. doi: 10.1186/s12889-019-7976-6.
Results Reference
derived

Learn more about this trial

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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