World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN70177564
Date of registration: 02/07/2014
Prospective Registration: No
Primary sponsor: The National Research Center For The Working Environment (NRCWE) (Denmark)
Public title: Improving school teacher?s psychological wellbeing and work ability by a workplace-based intervention ? The BALANCE project
Scientific title: The BALANCE project - A cluster-randomized trial of a complex workplace based intervention to maintain or improve work ability among school teachers at risk for being at reduced psychological wellbeing.
Date of first enrolment: 01/04/2013
Target sample size: 1000
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN70177564
Study type:  Interventional
Study design:  A cluster randomized controlled trial comparing an intervention group with an assessment only control group. (Quality of life)  
Phase: 
Countries of recruitment
Denmark
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Jesper    Kristiansen
Address:  Lerso Parkallé 105 2100 Copenhagen Denmark
Telephone:
Email: jkr@nrcwe.dk
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: All public schools in the municipal of Copenhagen got the possibility to seek for participation in the project - both school teachers (children age: 7-15 years) and preschool teachers (children age: 6 years) from the participating schools will be part of the study population.
Exclusion criteria: Exclusion criteria for participating in the project:
Special schools (as for example schools for deaf students) are not invited to participate in the project

Exclusion criteria for participation in the scientific evaluation of the study:
The school management and school employees who have other functions than teaching are not part of the study population

Exclusion criteria for participation in the scientific evaluation of the study:
The school management and school employees who have other functions than teaching are not part of the study population


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
School teachers with or without mental health problems working at the participating schools.
Not Applicable
Intervention(s)
The individual focused interventions include four components:
1. A screening to identify individuals with reduced psychological wellbeing
2. A case manager is appointed to contact the individuals with reduced psychological wellbeing identified in the screening. The case manager will through personal conversations clarify the needs and give support and motivation to participate in other parts of the individual intervention.
3. A course in stress management is one of the options offered
4. Job task modification, a time-limited adjustment of job demands and the current level of resources, is another option offered to the teachers with reduced psychological wellbeing.

The organization focused intervention includes three components:
1. Education of the ?Triad? (that is, representatives from the school management, the local shop steward and the local health and safety representative). The Triad receives training to improve their ability to support teachers with reduced psychological well-being, especially regarding those participating in the individual focused intervention. Furthermore the triad is trained to cooperate about improving the psychosocial working environment for all teachers of the school.
2. A seminar is organized at each school for all teachers. The purpose of the seminar is to increase focus at the school on an inclusive and supporting culture and reduce stigmatization of employees with mental health problems.
3. The seminar is the starting point for the final organizational intervention component which is activities centered around a theme selected by each school - a theme that has been found relevant for improving the psychosocial working environment of the specific workplace, for example improvement of support from colleagues.

The duration of the intervention is 12 months.
Primary Outcome(s)
The primary outcomes are:
1. The change from baseline (before the intervention) to the first follow-up (post-intervention) in psychological wellbeing assessed by WHO-5
2. The change from baseline to the first follow-up in work ability measured by the Work-Role Functioning Questionnaire (WRFQ)
3. The change from baseline to the first follow-up in work-related fatigue measured by Need for Recovery Questionnaire (NFR)
The change from baseline will be analyzed in a mixed effects model including the intervention as a categorical variable defined according to the intention-to-treat principle, and with the baseline value of the specific outcome as a covariate. The correlation between persons from the same school will be modelled using a compound symmetry covariance structure.

Additional primary outcomes are:
1. Sickness absence
2. Employment status
These are assessed from the employer?s records for the 12 months periods starting January 2014 (follow-up period). The influence of the intervention on sickness absence will be analyzed in a Cox proportional hazard regression model for interval-censored data using duration of the absence period as the time scale. The correlation between measurements within the individual and within the school will be modelled by including a random effect of individual and a random effect of school. The observation will be censored in case of termination of employment, death, or end of follow-up. The target event when analyzing employment status will be termination of employment at the school, while censoring at termination due to death, at age 65 years (standard age for old-age pension in Denmark), or at end of follow-up, whichever comes first. In these analyses, age will be used as the time scale.
Secondary Outcome(s)
The first group of secondary outcomes consists of changes from baseline to follow-up in psychological wellbeing measures complementary to the primary outcomes:
1. Mental health assessed with the Mental Health Inventory-5 (MHI-5)
2. Work ability (WAI)
3. Symptoms of depression and anxiety (SCL-90)
4. Sleep problems (KSS)

The second group of secondary outcomes consists of changes from baseline to follow-up of measures assessing the perceived psychosocial working environment:
1. Social support from colleagues (COPSOQ)
2. Social support from the manager (COPSOQ)
3. Social community at work (COPSOQ)
4. Quality of the management (COPSOQ)
5. Social capital among colleagues and between the teachers and the management
6. Expectations with regard to continue to work at the current school

Finally, a third group of secondary outcomes will be the change from baseline to 1 year after completion of the interventions (second follow-up) in all the variables mentioned above for:
1. Psychological wellbeing
2. Work ability
3. Work-related fatigue
4. Perceived working environment etc.
Secondary ID(s)
N/A
Source(s) of Monetary Support
Danish Government (Grant from the Social Reserve Program 2012) Grant number 17.21.02.60 (Denmark)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history