- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02694211
Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation (SPA)
Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation (SPA)
Study Overview
Detailed Description
Stress-related illnesses are today together with musculoskeletal disorders the predominant cause of production loss and absenteeism. The risks of developing stress-related mental illness is today well established, however, it is less studied how this can be successfully treated or prevented in workplaces through interventions.
The SPA project intends to evaluate the method the Productivity Measurement and Enhancement System (ProMES). The method is mainly evaluated for production improvement, but there are indications that it also has stress-reducing effect on working groups. The method gives employees within health care opportunities to participate actively in productivity-enhancing measures. The employees, along with their immediate supervisors, identify and prioritize responsive and desirable results in all of the activities important dimensions. International studies have shown that participation (participation) has positive effects on employee performance and attitudes.
The aim of this study is to test whether efforts in targeting the organization and work environment can reduce stress and prevent stress-related ill health in the workplace. Primary outcomes of the study are tense work i.e. imbalance between demand and control and other primary indicators of stress, such as sleep and recovery.
The hypothesis in study 1 is that productivity enhancing workplace interventions based on a participative approach also increases employees' sense of control and control over their own work. This in turn means that the method also could be used to reduce the occurrence of tense work and thus affect / reduce the stress-related illness.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All employees (18-67 years) employed at the intervention and control primary care units, who were actually working at the time for this study
Exclusion Criteria:
- employees absent due to long-term illness,
- employees absent due to parental leave
- employees absent due to long-term studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group ProMES
Productivity measurement and enhancement system (ProMES) is a participatory intervention for productivity enhancement.
Core strategies of this method could be addressing known work stressors such as absence of influence and control, insufficient interaction with coworkers, unclear and conflicting tasks, insufficient participation in decision-making and insufficient feedback
|
Productivity measurement and enhancement system (ProMES) is a participatory intervention for productivity enhancement.
Core strategies of this method could be addressing known work stressors such as absence of influence and control, insufficient interaction with coworkers, unclear and conflicting tasks, insufficient participation in decision-making and insufficient feedback
|
No Intervention: Control group
No intervention, business as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in job strain (a measure of the balance between job demand and job control)
Time Frame: baseline, 6-months, 12-months
|
QPSNordic questionnaire
|
baseline, 6-months, 12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Effort-Reward Imbalance
Time Frame: baseline, 6-months, 12-months
|
Effort-Reward Imbalance Questionnaire
|
baseline, 6-months, 12-months
|
Change in experience of stress
Time Frame: baseline, 6-months, 12-months
|
Single item stress question from Elo, A-L., Leppänen, A., Lindström K., Ropponen, T. OSQ-Occupational Stress Questionnaire: user's instructions.
Helsinki: Finnish Institute of Occupational health; 1992.
Reviews 19.
|
baseline, 6-months, 12-months
|
change in sleep difficulties
Time Frame: baseline, 6-months, 12-months
|
Two single questions Reference: Åkerstedt, T., Knutsson, A., et al. 2002.
Att predicera sömnstörning, insomningsrisk och mental trötthet - tre delstudier.
Psykosocial belastning och riskfaktorer för hjärtkärlsjukdom.
Arbete och Hälsa 2002:7.
Westerholm, P. Stockholm, Arbetslivsinstitutet
|
baseline, 6-months, 12-months
|
change in Recovery
Time Frame: baseline, 6-months, 12-months
|
One single question.
Reference: Aronsson, G. och Svensson, L. 1997.
Nedvarvning, återhämtning och hälsa bland lärare i grund- och gymnasieskolan.
Arbete och Hälsa 1997:21.
Stockholm, Arbetslivsinstitutet.
|
baseline, 6-months, 12-months
|
change in depression
Time Frame: baseline, 6-months, 12-months
|
Hospital Anxiety and Depression Scale
|
baseline, 6-months, 12-months
|
change in Sick leave
Time Frame: baseline, 6-months, 12-months
|
One single question:How many working days during the last 7 days, have you been away from work because of sick leave?
|
baseline, 6-months, 12-months
|
change in General health
Time Frame: baseline, 6-months, 12-months
|
A question from General Health Questionnaire (WHO)
|
baseline, 6-months, 12-months
|
change in Productivity
Time Frame: baseline, 6-months, 12-months
|
Questions from "Measuring production loss due to health and work environment problems: construct validity and implications."(Report)
Lohela Karlsson, Malin ; Hagberg, Jan ; Bjorklund, Christina ; Bergstrom, Gunnar ; Jensen, Irene Journal of Occupational and Environmental Medicine, Dec, 2013, Vol.55(12), p.1475(9).
Karolinska institutet.
Stockholm
|
baseline, 6-months, 12-months
|
change in Exhaustion
Time Frame: baseline, 6-months, 12-months
|
Oldenburg Burnout Inventory
|
baseline, 6-months, 12-months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irene Jensen, Professor, Karolinska Institutet
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/2200-31/5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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