Common Mental DisordersNCT03322839
Evaluating the Effectiveness of Multifaceted Implementation Strategies for Implementing a Guideline for the Prevention of Common Mental Disorders at the Workplace in Schools
A study testing Multifaceted implementation strategies and Single implementation strategy in people with Common Mental Disorders, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Common Mental Disorders
- What is being tested?
- Multifaceted implementation strategies and Single implementation strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 1 siteSweden
- Study dates
- 12 Sep 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all individuals who are employed by the participating schools
Who cannot join
- individuals employed by the participating municipalities and not by the participating schools, for example cleaning personal. Individuals on sick-leave
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute
Stockholm, 171 77
About this study
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
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).
- Conditions
- Common Mental Disorders
- Being tested
- Multifaceted implementation strategies, Single implementation strategy
- Keywords
- Guideline-adherence, Implementation, Implementation-strategies, Randomized-controlled-trial, Organisational risk-factors, Schools, Social risk-factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted implementation strategiesBehavioural
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 strategyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted implementation strategies | Experimental | 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. Receives: Behavioral: Multifaceted implementation strategies |
| Single implementation strategy | Active comparator | The control-schools will only receive training to the school-management. Receives: Behavioral: Single implementation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: At baseline and 6, 12 and 24 months after baseline
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).
Measured: At baseline and 6, 12 and 24 months after baseline
Secondary outcomes (30)
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)
Measured: At baseline and 6, 12 and 24 months after baseline
Job demands
Change from baseline in self-reported job-demands as assessed by 11 items of the Copenhagen Psychosocial Questionnaire (response form 1-5)
Measured: At baseline and 6, 12 and 24 months after baseline
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)
Measured: At baseline and 6, 12 and 24 months after baseline
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)
Measured: At baseline and 6, 12 and 24 months after baseline
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)
Measured: At baseline and 6, 12 and 24 months after baseline
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)
Measured: At baseline and 6, 12 and 24 months after baseline
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)
Measured: At baseline and 6, 12 and 24 months after baseline
Work engagement
Change from baseline in self-reported engagement as assessed by 3 items of the Utrecht Work Engagement Scale (response-form 1-7)
Measured: At baseline and 6, 12 and 24 months after baseline
Self-perceived health
Change from baseline in self-perceived health as assessed with a single question (response-form 1-5)
Measured: At baseline and 6, 12 and 24 months after baseline
Self-reported stress
Change from baseline in self-reported stress as assessed with a single question (response-form 1-5)
Measured: At baseline and 6, 12 and 24 months after baseline
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)
Measured: At baseline and 6, 12 and 24 months after baseline
Recovery
Change from baseline in self-reported recovery as assessed with 1 item (response-form 1-5)
Measured: At baseline and 6, 12 and 24 months after baseline
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)
Measured: At baseline and 6, 12 and 24 months after baseline
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)
Measured: At baseline and 6, 12 and 24 months after baseline
Self-reported sickness absenteeism
Change from baseline in self-reported sickness absenteeism as assessed by 2 items
Measured: At baseline and 6, 12 and 24 months after baseline
Registered sickness absenteeism
Change in total sick-leave due to common mental disorders in days, register data (sickness benefit and disability pension).
Measured: 12 months prior to baseline, and during 24 months after baseline
Recognition (reward)
Change from baseline self-reported collaboration and leadership as assessed by 3-items of Copenhagen Psychosocial Questionnaire (response-format 1-5)
Measured: At baseline and 6, 12 and 24 months after baseline
Self-reported stress (SMS)
Change from baseline in self-reported stress as assessed by one item sent by text-message by mobile-phone
Measured: Measured every 4th week over 12 months from baseline
Process evaluation data
Process data will be collected over the 24 months. This data will be assessed by focus-group interviews.
Measured: Assessed during the 24 month study period.
Process evaluation data
Process data will be collected over the 24 months. This data will be assessed by questionnaires
Measured: Assessed during the 24 month study period.
Process evaluation data
Process data will be collected over the 24 months. This data will be assessed by observation
Measured: Assessed during the 24 month study period.
Process evaluation data
Process data will be collected over the 24 months. This data will be assessed by documentation.
Measured: Assessed during the 24 month study period.
Barriers
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by focus-group interviews
Measured: Assessed during the 24 month study period
Barriers
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by questionnaires
Measured: Assessed during the 24 month study period
Barriers
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by observation
Measured: Assessed during the 24 month study period
Barriers
Information will be collected on possible barriers that may have influenced the implementation process. This data will be assessed by documentation.
Measured: Assessed during the 24 month study period
Facilitators
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by focus-group interviews
Measured: Assessed during the 24 month study period
Facilitators
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by questionnaires
Measured: Assessed during the 24 month study period
Facilitators
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by observation
Measured: Assessed during the 24 month study period
Facilitators
Information will be collected on possible facilitators that may have influenced the implementation process. This data will be assessed by documentation.
Measured: Assessed during the 24 month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start12 Sep 2017
- Primary completion30 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common Mental DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Kwak, Karolinska Institutet
- Investigators
- Lydia Kwak, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322839
- Sponsor's protocol ID
- 150571
- Other IDs
- 150571
- Status last verified
- Sep 2020
- First submitted
- 19 Sep 2017
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The ethical approval does not allow data-sharing of individual participation data.
Publications
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.
PubMed 31829186
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03322839
- Acronym / sponsor ID
- 150571
- Conditions
- Common Mental Disorders
- Keywords
- Guideline-adherence, Implementation, Implementation-strategies, Randomized-controlled-trial, Organisational risk-factors, Schools, Social risk-factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 732 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted implementation strategies | Experimental | Behavioral: Multifaceted implementation strategiesThe 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. |
| Single implementation strategy | Active comparator | Behavioral: Single implementation strategyThe control-schools will only receive training to the school-management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all individuals who are employed by the participating schools
Key exclusion criteria (1 listed)
- individuals employed by the participating municipalities and not by the participating schools, for example cleaning personal. Individuals on sick-leave
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted implementation strategiesThe 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. | Behavioural | Multifaceted implementation strategies |
| Single implementation strategyThe 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 | Behavioural | Single implementation strategy |
Primary outcome
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".
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).
30 secondary outcomes
Psychosocial safety climate
Time frame: At baseline and 6, 12 and 24 months after baseline
Job demands
Time frame: 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
Social support colleagues
Time frame: 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
Commitment to the workplace
Time frame: 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
Work engagement
Time frame: 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
Self-reported stress
Time frame: 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
Recovery
Time frame: 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
Work performance impairment due to problems in the work environment
Time frame: 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
Registered sickness absenteeism
Time frame: 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
Self-reported stress (SMS)
Time frame: Measured every 4th week over 12 months from baseline
Process evaluation data
Time frame: Assessed during the 24 month study period.
Process evaluation data
Time frame: Assessed during the 24 month study period.
Process evaluation data
Time frame: Assessed during the 24 month study period.
Process evaluation data
Time frame: Assessed during the 24 month study period.
Barriers
Time frame: Assessed during the 24 month study period
Barriers
Time frame: Assessed during the 24 month study period
Barriers
Time frame: Assessed during the 24 month study period
Barriers
Time frame: Assessed during the 24 month study period
Facilitators
Time frame: Assessed during the 24 month study period
Facilitators
Time frame: Assessed during the 24 month study period
Facilitators
Time frame: Assessed during the 24 month study period
Facilitators
Time frame: Assessed during the 24 month study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Derived from this study: PubMed 31829186Kwak 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.
- Individual participant dataSharing planned: No. The ethical approval does not allow data-sharing of individual participation data.
Related trials for Common Mental Disorders
Recruiting
Evaluation of a Decision-Support Tool for Blood Biomarker Testing for Alzheimer's Disease in Primary Care
Cognitive Abnormality
Recruiting
Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)
Substance Use Disorders
RecruitingObservational study
Post Operative Cognitive Dysfunction After Oncologic Surgery
Emergence Delirium, Post-Operative Cognitive Dysfunction
Recruiting
Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression
Mental Health Care, Anxiety and Depression
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia Kwak, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted implementation strategies and Single implementation strategy in people with Common Mental Disorders, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline adherence (implementation effectiveness) (time frame: At baseline and 6, 12 and 24 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03322839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.