NCT03322839

Evaluating the Effectiveness of Multifaceted Implementation Strategies for Implementing a Guideline for the Prevention of Common Mental Disorders at the Workplace in Schools

Completed NA Last updated 14 September 2020

What this trial tests

NA trial testing Multifaceted implementation strategies in Common Mental Disorders in 732 participants. Completed in 31 December 2019.

Timeline

12 September 2017

Primary endpoint
30 October 2019

31 December 2019

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	732
Start date	12 September 2017
Primary completion	30 October 2019
Estimated completion	31 December 2019
Sites	1 location across Sweden

Drugs / interventions tested

• Multifaceted implementation strategies
• Single implementation strategy

Conditions studied

• Common Mental Disorders — all drugs for Common Mental Disorders →

Sponsor

Karolinska Institutet

Who can join

Eligibility, any sex, with Common Mental Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recruiting in intervention studies: challenges and solutions.
   Axén I, Björk Brämberg E, Galaasen Bakken A, Kwak L. · · 2021 · cited 21× · PMID 33495262 · DOI 10.1136/bmjopen-2020-044702
2. 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.
   Kwak L, Lornudd C, Björklund C, Bergström G, et al · · 2019 · cited 11× · PMID 31829186 · DOI 10.1186/s12889-019-7976-6
3. The effectiveness of implementing the Guideline for the Prevention of Mental Ill-health Problems at the Workplace on health-outcomes, organizational and social risk factors: a cluster-randomized controlled trial in Swedish schools.
   Toropova A, Rödlund A, Björklund C, Schäfer Elinder L, et al · · 2023 · cited 5× · PMID 37481748 · DOI 10.5271/sjweh.4108