Condition category
Mental and Behavioural Disorders
Date applied
02/01/2020
Date assigned
12/02/2020
Last edited
14/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Poor mental health is the dominant cause of sick leave in Sweden today and we have strong reasons to believe that certain work environment conditions is one contributing factor. We know which these conditions are, however, we don't know how to change them. This means that we lack knowledge on what methods are effective in improving organisational and social work conditions and stress in the workplace.

Interventions to address work-related stress are increasing but are mainly secondary or tertiary. Secondary interventions are directed at individuals at risk of developing stress responses. Tertiary interventions focus on treating existing diagnosed conditions. Primary interventions, on the other hand, are preventive and aim to deal with organisational factors as causal stress agents. The aim of the study is to evaluate an organisational primary intervention with the aim to improve organisational and social work conditions and reduce stress within the construction industry.

Who can participate?
Managers and employees within the two studied regions in the construction company.

What does the study involve?
The study involves one intervention and one matched control group. For the intervention group, the project contains three phases. In the first phase we conducted a needs assessment using a formative evaluation. Interviews were carried out and a survey in order to answer the questions: What works well and what needs to be improved regarding the organizational and social work environment?

In the second phase researchers and representatives from different levels and districts worked together to prioritize outcomes and define essential intervention elements. We also discussed and formulated suggestions for how the intervention could be implemented in a good way. In the third phase implementation and evaluation take place.

The control group participates through answering the baseline and follow-up survey.

What are the possible benefits and risks of participating?
Benefits: Reduced stress and improved work conditions.
Risks: Lack of improvements may cause disappointment among participants which in turn may lead to a more negative perception of work.

Where is the study run from?
Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden

When is the study starting and how long is it expected to run for?
May 2019 - June 2021

Who is funding the study?
AFA Insurance, Sweden

Who is the main contact?
Dr Gun Johansson
gun.johansson@ki.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gun Johansson

ORCID ID

http://orcid.org/0000-0003-1877-8569

Contact details

Solnavägen 4
Stockholm
11365
Sweden
+46 (0)733 628362
gun.johansson@ki.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Evaluation of a primary organisational co-created intervention with the aim to improve organisational and social work conditions and decrease stress within the construction industry

Acronym

Study hypothesis

Given that the managers adhere to the intervention we expect to see a greater improvement in work conditions (role clarity, influence, work pace, quantitative job demands), team effectiveness and stress in the intervention group compared to the control group.

Ethics approval

Approved 21/05/2019, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110,
750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2019-02662

Study design

This is a controlled trial with one intervention and one control group with a 12 month follow-up

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet.

Condition

Work related stress

Intervention

Current interventions as of 14/02/2020:
The core intervention components are:
1. Assessment for first line managers
Assessment = making structured and collective (involving blue-collar workers) planning for all elements of the production (planning for blue-collar workers)
2. Duties clarification for project managers
Duties clarification and staffing plan = making clear role descriptions for all members of the production teams (white-collar workers), visualizing the plan and revising it continuously throughout the project. The staffing plan is closely related to the duties clarification and should also be scrutinized and revised.
3. For the support function team ("operational support") the highest manager will give feedback on the results of the survey and together with the team conduct a tailored action plan. Hence, the intervention activities will not be assessment and duties clarification for this group.

The study involves one intervention and one matched control group. For the intervention group, the project contains three phases. In the first phase we conducted a needs assessment using a formative evaluation. Interviews were carried out and a survey in order to answer the questions: What works well and what needs to be improved regarding the organizational and social work environment?

In the second phase researchers and representatives from different levels and districts worked together to prioritize outcomes and define essential intervention elements. We also discussed and formulated suggestions for how the intervention could be implemented in a good way. In the third phase implementation and evaluation take place.

The control group participates through answering the baseline and follow-up survey.


Previous interventions:
The core intervention components are:
1. Assessment for first line managers
Assessment = making structured and collective (involving blue-collar workers) planning for all elements of the production (planning for blue-collar workers)
2. Duties clarification for project managers
Duties clarification and staffing plan = making clear role descriptions for all members of the production teams (white-collar workers), visualizing the plan and revising it continuously throughout the project. The staffing plan is closely related to the duties clarification and should also be scrutinized and revised.
3. For the two support function teams (employees not dedicated to a project) the highest manager will give feedback on the results of the survey and together with the team conduct a tailored action plan. Hence, the intervention activities will not be assessment and duties clarification.

The study involves one intervention and one matched control group. For the intervention group, the project contains three phases. In the first phase we conducted a needs assessment using a formative evaluation. Interviews were carried out and a survey in order to answer the questions: What works well and what needs to be improved regarding the organizational and social work environment?

In the second phase researchers and representatives from different levels and districts worked together to prioritize outcomes and define essential intervention elements. We also discussed and formulated suggestions for how the intervention could be implemented in a good way. In the third phase implementation and evaluation take place.

The control group participates through answering the baseline and follow-up survey.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Stress, measured with the COPSOQ III questionnaire at baseline and 12 months

Secondary outcome measures

Current secondary outcome measures as of 14/02/2020:
1. Quantitative demands, measured with the COPSOQ III questionnaire at baseline and 12 months
2. Role clarity, measured with the COPSOQ III questionnaire at baseline and 12 months
3. Psychosocial safety climate, measured with questionnaire at baseline and 12 months
4. Team effectiveness, measured with questionnaire at baseline and 12 months
5. Staffing, measured with questionnaire at baseline and 12 months
6. Planning, measured with questionnaire at baseline and 12 months

Previous secondary outcome measures:
1. Quantitative demands, measured with the COPSOQ III questionnaire at baseline and 12 months
2. Work pace, measured with the COPSOQ III questionnaire at baseline and 12 months
3. Role clarity, measured with the COPSOQ III questionnaire at baseline and 12 months
4. Influence, measured with the COPSOQ III questionnaire at baseline and 12 months
5. Psychosocial safety climate, questionnaire at baseline and 12 months
6. Team effectiveness, questionnaire at baseline and 12 months

Overall trial start date

01/01/2018

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Working in the recruited organisation at the time of recruitment and the follow-up endpoint
2. Age 18-65

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Intervention group = 366 Control group =472

Participant exclusion criteria

1. Regional manager
2. District managers

Recruitment start date

31/05/2019

Recruitment end date

30/06/2021

Locations

Countries of recruitment

Sweden

Trial participating centre

Institute of environmental medicine Karolinska Institutet
Gothenburg
41250
Sweden

Sponsor information

Organisation

Karolinska Institute

Sponsor details

Nobels väg 13
Solna
171 65
Sweden
+46 (0) 733 628362
gun.johansson@ki.se

Sponsor type

University/education

Website

https://ki.se/imm

Funders

Funder type

Industry

Funder name

AFA Försäkring

Alternative name(s)

AFA Insurance

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

Sweden

Results and Publications

Publication and dissemination plan

Publication and dissemination plan
1.Scientific publications (protocol and papers)
2. Conference presentations
3. Dissemination within the construction company is ongoing and will develop further when we know more about the results.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

01/03/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/02/2020: The following changes were made to the trial record: 1. The interventions and secondary outcome measures were updated. 2. The recruitment end date was changed from 31/05/2019 to 30/06/2021. 07/01/2020: Trial’s existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)