- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322839
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
732
Phase
- 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
-
-
-
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
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 |
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.
|
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.
|
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
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
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
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.
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)
September 12, 2017
Primary Completion (Actual)
October 30, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
September 19, 2017
First Submitted That Met QC Criteria
October 23, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Actual)
September 14, 2020
Last Update Submitted That Met QC Criteria
September 10, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Common Mental Disorders
-
University of KonstanzLudwig-Maximilians - University of Munich; Jimma UniversityCompletedCommon Mental Disorders (CMD) | Psychotic Symptoms
-
The University of Hong KongRecruiting
-
The University of Hong KongCompletedCommon Mental DisordersHong Kong
-
New York State Psychiatric InstituteUniversity of Pennsylvania; Columbia UniversityRecruitingCommon Mental Disorders | Severe Mental DisorderMozambique
-
Central South UniversityRecruitingCommon Mental DisorderChina
-
The University of Hong KongCompletedWomen at Risk of Common Mental DisordersHong Kong
-
Karolinska InstitutetCompletedCommon Mental Disorders and/or Stress Related SymptomsSweden
-
King's College LondonCompletedAlcohol Use Disorder | Common Mental DisordersUnited Kingdom
-
Mental Health Services in the Capital Region, DenmarkCentral Denmark Region; Københavns Kommune; The Danish Agency for Labour Market... and other collaboratorsCompletedPersonality Disorders | Depression | Stress | Anxiety | Common Mental Disorders | Functional Disease PresentDenmark
-
University of ZurichCompletedDepression | PTSD | Anxiety | Trauma | Distress | Functional Disabilities | Common Mental Health ProblemsSwitzerland
Clinical Trials on Multifaceted implementation strategies
-
University of California, San DiegoUniversity of Nigeria NsukkaRecruitingCervical Cancer | HIVUnited States, Nigeria
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
University of North Carolina, Chapel HillNational Center for Complementary and Integrative Health (NCCIH)Enrolling by invitation
-
National Center for Chronic and Noncommunicable...World Health OrganizationEnrolling by invitationHypertension | Diabetes Mellitus, Type 2China
-
Washington University School of MedicineRecruitingBehavior | Process, Acceptance | Inertia of AccommodationUnited States
-
Harvard School of Public Health (HSPH)National Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBreast Cancer Screening | Implementation | Colorectal Cancer ScreeningUnited States
-
Linkoeping UniversityCompleted
-
Corporacion Parc TauliHospital Clinic of Barcelona; Instituto de Salud Carlos III; Institut Catala...Unknown
-
Columbia UniversityWeill Medical College of Cornell University; New York Presbyterian HospitalRecruitingHypertensionUnited States
-
Mayo ClinicEnrolling by invitationCardiovascular Risk | Cardiovascular PreventionUnited States