Mental DisorderNCT05019937
Exploring Effectiveness and Mechanism of Change of an Implementation Strategy on Guideline Implementation in Schools
A study testing Educational meeting, Implementation team and Workshops in people with Mental Disorder and Stress, run by Lydia Kwak at 1 site in Sweden.
Trial summary
This project is a two-armed randomized-controlled trial exploring the effectiveness and mechanisms of change of two different implementation strategies for implementing the Guideline for the prevention of mental ill-health at the workplace. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Stress
- What is being tested?
- Educational meeting, Implementation team and Workshops
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,276 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 31 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All personnel employed by the school
Who cannot join
- Personnel not employed by the school (e.g. cleaning- and canteen-personnel)
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: A Randomized Controlled Trial in Schools Aimed at Testing the Effectiveness of Implementation Strategies, Including Mechanism of Change, on Adherence to the Guideline for the Prevention of Common Mental Disorders at the Workplace.
This project is a two-armed randomized-controlled trial exploring the effectiveness and mechanisms of change of two different implementation strategies for implementing the Guideline for the prevention of mental ill-health at the workplace. The project will be conducted among public primary and secondary schools belonging to four municipalities in Sweden. Data will be collected with mixed-methods at baseline and different time-points of follow-up.
Read the detailed description
There is an urgent need for more knowledge on effective implementation strategies, as two-thirds of implementation efforts fail to achieve the intended change, and half have no effect on outcomes of interest. These implementation failures are partly due to the limited understanding of how implementation strategies work-the mechanisms of change through which implementation strategies affect implementation. This project will fill this research-gap by exploring mechanism of change during a cluster randomized controlled trial that compares the effectiveness of two implementation strategies for implementing the Guideline for the prevention of mental ill-health at the workplace in schools. Schools are chosen as the setting for implementation given the high prevalence of mental ill-health among teachers. Moreover, schools lack a structured approach to the prevention of mental ill-health. The aim of the project is to investigate how implementation strategies affect the defined mechanisms and guideline implementation. Mechanisms that will be tested include hypothesized mediators originating from the individual behavior change theory COM-B. The project will be conducted in public primary and secondary schools in four municipalities in Sweden. Data will be collected with mixed-methods from school-management and personnel at baseline, and different time-points during follow-up.
- Conditions
- Mental Disorder, Stress
- Being tested
- Educational meeting, Implementation team, Workshops, Plan-Do-Study-Act improvement cycles, Internal facilitator
- Keywords
- Guideline, Implementation, Implementation strategies, Mechanism of change, Workplaces, Organisational and social work environment, Schools
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational meetingBehavioural
Also called Conduct an educational meeting (15) - ERIC cluster Train and educate stakeholders
The investigators will hold a full-day educational meeting. The meeting will include educating 4-5 representatives of each school, and school-district representatives about the guideline and the advantages of adhering to the guideline.
Implementation teamBehavioural
Also called Organize implementation teams (48) - ERIC cluster Develop stakeholder inter-relationships
The school-principal forms an implementation team that is responsible for implementing the guideline within their school. The team members (n=4-5) reflect on the implementation progress, make, and refine plans according to Plan-Do-Study-Act, share lessons learned and support each other.
WorkshopsBehavioural
Also called Conduct ongoing training (19) - ERIC cluster Train and educate stakeholders
The investigators will hold 5 workshops. Workshops will include providing in-depth knowledge and skills on the guideline recommendations. During each workshop one of the guideline recommendations will be presented and discussed.
Moreover, the concept of Plan-Do-Study-Act will be introduced and how it can be used to implement the guideline recommendation(s). During each workshop, the implementation team will share with the group their developed PLAN and barriers and facilitators that have influenced the execution of the PLAN.
Plan-Do-Study-Act improvement cyclesBehavioural
Also called Conduct cyclical small tests of change (14) - ERIC cluster Use evaluative and iterative strategies
The implementation team will implement the guideline in a cyclical manner by using Plan-Do-Study-Act. First a Plan is specified during the workshop by using SMART-goals, next the change is carried out between workshops (Do), the implementation team analyses whether it went well and what needs to be improved (Study), changes are made (Act) and finally the next cycle is planned.
Internal facilitatorBehavioural
Also called Implementation facilitation (10) - ERIC cluster Provide interactive assistance
Each municipality assigns one or more internal facilitators, for example HR-strategist. The internal facilitator will meet their local implementation teams during the educational meeting and workshops. Further meeting can be scheduled based on the needs of each implementation team. The internal facilitator will create a supportive environment within which knowledge is exchanged, barriers to implementation identified, and processes or solutions to overcome those barriers developed, applied, and refined. Moreover, the internal facilitator will establish ongoing audit and feedback processes.
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted implementation strategy | Experimental | Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components Receives: Behavioral: Educational meeting; Behavioral: Implementation team; Behavioral: Workshops; Behavioral: Plan-Do-Study-Act improvement cycles; Behavioral: Internal facilitator |
| Single implementation strategy | Active comparator | Schools randomized to this arm will be exposed to a single implementation strategy, which contains one implementation component Receives: Behavioral: Educational meeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline adherence
Change from baseline in adherence to the recommendations of the guideline during 12-, and 24-months follow-up. Guideline adherence will be assessed with a checklist and questionnaire developed for the purpose of the project.
Measured: At baseline, 12- and 24 months follow-up
Secondary outcomes (5)
Self-perceived health
Change from baseline in self-perceived health during 12-, and 24-months follow-up. Self-perceived health is assessed with a single question from the SF-12 Health Survey (Ware JE, Kosinski MA, \& DM, 2002)
Measured: At baseline, 12- and 24-months follow-up
Self-reported stress
Change from baseline in self-reported stress during 12-, and 24-months follow-up. Self-reported stress is assessed with a single item (Arapovic-Johansson, Wahlin, Kwak, Bjorklund, \& Jensen, 2017; Elo, Leppanen, \& Jahkola, 2003).
Measured: At baseline, 12- and 24-months follow-up
Psychosocial safety climate
Change from baseline in psychosocial safety climate during 12-, and 24-months follow-up. Psychosocial safety climate is assessed with PSC-4, which is a short questionnaire with 4 items measuring the Psychosocial Safety Climate at work (Berthelsen \& Muhonen, 2017)
Measured: At baseline, 12- and 24-months follow-up
Organisational readiness to implement
Change from baseline in organisational readiness to implement the guideline during 12-, and 24-months follow-up. Organisational readiness to implement will be assessed with the Leader Readiness to Implement Tool (LRIT) developed and validated by Cook et al. manuscript submitted. With the tool a total readiness index will be calculated, but also a change efficacy score and a change commitment score indicating the confidence and commitment to implement the guideline within the organisation (school).
Measured: At baseline, 12- and 24-months follow-up
Implementation leadership
Change from baseline in implementation leadership during 12- and 24-months follow-up. Implementation leadership will be assessed with items from the S-ILS (Aarons, Ehrhart, \& Farahnak, 2014; Lyon et al., 2018). The S-ILS assesses the degree to which a leader is Proactive, Knowledgeable, Supportive, and Perseverant in implementing evidence-based practice (the guideline). Scores for the subscales will be calculated and a total score for the S-ILS is calculated by taking a mean of the scale scores.
Measured: At baseline, 12- and 24-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-armed cluster-randomized controlled trail
- Masking
- None (open label)
- Enrolment
- 2,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lydia Kwak
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor-investigator, Lydia Kwak, Karolinska Institutet
- Investigators
- Lydia Kwak, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019937
- Sponsor's protocol ID
- 2020-01214
- Other IDs
- 2020-01214
- Status last verified
- Mar 2024
- First submitted
- 9 Aug 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodlund A, Lengnick-Hall R, Toropova A, Powell BJ, Elinder LS, Bjorklund C, Kwak L. The roads towards fidelity: a mixed-method study of mechanisms of a multifaceted implementation strategy to improve implementation of a guideline for the prevention of mental Ill-health at the workplace in a school setting. Implement Sci Commun. 2026 Jun 11;7(1):114. doi: 10.1186/s43058-026-01010-0.
PubMed 42277969Rodlund A, Toropova A, Lengnick-Hall R, Powell BJ, Schafer Elinder L, Bjorklund C, Kwak L. A cluster-randomized controlled trial assessing the effectiveness of a multifaceted versus a discrete implementation strategy on fidelity to an occupational guideline for the prevention of mental health problems at the workplace: a dual perspective from Swedish schools. Implement Sci Commun. 2025 Nov 21;6(1):127. doi: 10.1186/s43058-025-00821-x.
PubMed 41272910
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial in Schools Aimed at Testing the Effectiveness of Implementation Strategies, Including Mechanism of Change, on Adherence to the Guideline for the Prevention of Common Mental Disorders at the Workplace.
- ClinicalTrials.gov ID
- NCT05019937
- Acronym / sponsor ID
- 2020-01214
- Conditions
- Mental Disorder, Stress
- Keywords
- Guideline, Implementation, Implementation strategies, Mechanism of change, Workplaces, Organisational and social work environment, Schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,276 participants (actual)
- Lead sponsor
- Lydia KwakUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Aug 2021 (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.
This project is a two-armed randomized-controlled trial exploring the effectiveness and mechanisms of change of two different implementation strategies for implementing the Guideline for the prevention of mental ill-health at the workplace. The project will be conducted among public primary and secondary schools belonging to four municipalities in Sweden. Data will be collected with mixed-methods at baseline and different time-points of follow-up.
Detailed description
There is an urgent need for more knowledge on effective implementation strategies, as two-thirds of implementation efforts fail to achieve the intended change, and half have no effect on outcomes of interest. These implementation failures are partly due to the limited understanding of how implementation strategies work-the mechanisms of change through which implementation strategies affect implementation. This project will fill this research-gap by exploring mechanism of change during a cluster randomized controlled trial that compares the effectiveness of two implementation strategies for implementing the Guideline for the prevention of mental ill-health at the workplace in schools. Schools are chosen as the setting for implementation given the high prevalence of mental ill-health among teachers. Moreover, schools lack a structured approach to the prevention of mental ill-health. The aim of the project is to investigate how implementation strategies affect the defined mechanisms and guideline implementation. Mechanisms that will be tested include hypothesized mediators originating from the individual behavior change theory COM-B. The project will be conducted in public primary and secondary schools in four municipalities in Sweden. Data will be collected with mixed-methods from school-management and personnel at baseline, and different time-points during follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-armed cluster-randomized controlled trail
| Arm | Type | Receives |
|---|---|---|
| Multifaceted implementation strategy | Experimental | Behavioral: Educational meeting, Behavioral: Implementation team, Behavioral: Workshops, Behavioral: Plan-Do-Study-Act improvement cycles, Behavioral: Internal facilitatorSchools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components |
| Single implementation strategy | Active comparator | Behavioral: Educational meetingSchools randomized to this arm will be exposed to a single implementation strategy, which contains one implementation component |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All personnel employed by the school
Key exclusion criteria (1 listed)
- Personnel not employed by the school (e.g. cleaning- and canteen-personnel)
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 |
|---|---|---|
| Educational meetingAlso: Conduct an educational meeting (15) - ERIC cluster Train and educate stakeholdersThe investigators will hold a full-day educational meeting. The meeting will include educating 4-5 representatives of each school, and school-district representatives about the guideline and the advantages of adhering to the guideline. | Behavioural | Multifaceted implementation strategy, Single implementation strategy |
| Implementation teamAlso: Organize implementation teams (48) - ERIC cluster Develop stakeholder inter-relationshipsThe school-principal forms an implementation team that is responsible for implementing the guideline within their school. The team members (n=4-5) reflect on the implementation progress, make, and refine plans according to Plan-Do-Study-Act, share lessons learned and support each other. | Behavioural | Multifaceted implementation strategy |
| WorkshopsAlso: Conduct ongoing training (19) - ERIC cluster Train and educate stakeholdersThe investigators will hold 5 workshops. Workshops will include providing in-depth knowledge and skills on the guideline recommendations. During each workshop one of the guideline recommendations will be presented and discussed. Moreover, the concept of Plan-Do-Study-Act will be introduced and how it can be used to implement the guideline recommendation(s). During each workshop, the implementation team will share with the group their developed PLAN and barriers and facilitators that have influenced the execution of the PLAN. | Behavioural | Multifaceted implementation strategy |
| Plan-Do-Study-Act improvement cyclesAlso: Conduct cyclical small tests of change (14) - ERIC cluster Use evaluative and iterative strategiesThe implementation team will implement the guideline in a cyclical manner by using Plan-Do-Study-Act. First a Plan is specified during the workshop by using SMART-goals, next the change is carried out between workshops (Do), the implementation team analyses whether it went well and what needs to be improved (Study), changes are made (Act) and finally the next cycle is planned. | Behavioural | Multifaceted implementation strategy |
| Internal facilitatorAlso: Implementation facilitation (10) - ERIC cluster Provide interactive assistanceEach municipality assigns one or more internal facilitators, for example HR-strategist. The internal facilitator will meet their local implementation teams during the educational meeting and workshops. Further meeting can be scheduled based on the needs of each implementation team. The internal facilitator will create a supportive environment within which knowledge is exchanged, barriers to implementation identified, and processes or solutions to overcome those barriers developed, applied, and refined. Moreover, the internal facilitator will establish ongoing audit and feedback processes. | Behavioural | Multifaceted implementation strategy |
Primary outcome
Guideline adherence
Time frame: At baseline, 12- and 24 months follow-up
Change from baseline in adherence to the recommendations of the guideline during 12-, and 24-months follow-up. Guideline adherence will be assessed with a checklist and questionnaire developed for the purpose of the project.
5 secondary outcomes
Self-perceived health
Time frame: At baseline, 12- and 24-months follow-up
Self-reported stress
Time frame: At baseline, 12- and 24-months follow-up
Psychosocial safety climate
Time frame: At baseline, 12- and 24-months follow-up
Organisational readiness to implement
Time frame: At baseline, 12- and 24-months follow-up
Implementation leadership
Time frame: At baseline, 12- and 24-months follow-up
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 20 Mar 2024.
- Derived from this study: PubMed 42277969Rodlund A, Lengnick-Hall R, Toropova A, Powell BJ, Elinder LS, Bjorklund C, Kwak L. The roads towards fidelity: a mixed-method study of mechanisms of a multifaceted implementation strategy to improve implementation of a guideline for the prevention of mental Ill-health at the workplace in a school setting. Implement Sci Commun. 2026 Jun 11;7(1):114. doi: 10.1186/s43058-026-01010-0.
- Derived from this study: PubMed 41272910Rodlund A, Toropova A, Lengnick-Hall R, Powell BJ, Schafer Elinder L, Bjorklund C, Kwak L. A cluster-randomized controlled trial assessing the effectiveness of a multifaceted versus a discrete implementation strategy on fidelity to an occupational guideline for the prevention of mental health problems at the workplace: a dual perspective from Swedish schools. Implement Sci Commun. 2025 Nov 21;6(1):127. doi: 10.1186/s43058-025-00821-x.
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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 Educational meeting, Implementation team and Workshops in people with Mental Disorder and Stress, run by Lydia Kwak 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 20 Mar 2024. 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 (time frame: At baseline, 12- and 24 months follow-up). 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 NCT05019937, which also lists 2 linked publications.
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 20 Mar 2024.