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
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
Overall status: COMPLETED
Phase: NA
Conditions: Common Mental Disorders
Keywords: Guideline-adherence
Implementation
Implementation-strategies
Randomized-controlled-trial
Organisational risk-factors
Schools
Social risk-factors
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 732
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Guideline adherence (implementation effectiveness)
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Exhaustion (intervention effectiveness)
timeFrame: At baseline and 6, 12 and 24 months after baseline
Secondary outcomes:
measure: Psychosocial safety climate
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Job demands
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Influence at work
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Social support colleagues
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Possibilities for development
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Commitment to the workplace
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Social support superior
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Work engagement
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Self-perceived health
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Self-reported stress
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Work-family conflict
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Recovery
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Work performance impairment due to health problems
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Work performance impairment due to problems in the work environment
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Self-reported sickness absenteeism
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Registered sickness absenteeism
timeFrame: 12 months prior to baseline, and during 24 months after baseline
measure: Recognition (reward)
timeFrame: At baseline and 6, 12 and 24 months after baseline
measure: Self-reported stress (SMS)
timeFrame: Measured every 4th week over 12 months from baseline
measure: Process evaluation data
timeFrame: Assessed during the 24 month study period.
measure: Process evaluation data
timeFrame: Assessed during the 24 month study period.
measure: Process evaluation data
timeFrame: Assessed during the 24 month study period.
measure: Process evaluation data
timeFrame: Assessed during the 24 month study period.
measure: Barriers
timeFrame: Assessed during the 24 month study period
measure: Barriers
timeFrame: Assessed during the 24 month study period
measure: Barriers
timeFrame: Assessed during the 24 month study period
measure: Barriers
timeFrame: Assessed during the 24 month study period
measure: Facilitators
timeFrame: Assessed during the 24 month study period
measure: Facilitators
timeFrame: Assessed during the 24 month study period
measure: Facilitators
timeFrame: Assessed during the 24 month study period
measure: Facilitators
timeFrame: Assessed during the 24 month study period
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Unit for Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute
Study officials:
affiliation: Karolinska Institutet
name: Lydia Kwak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.