Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation (SPA)
Primary Purpose
Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ProMES
Sponsored by
About this trial
This is an interventional prevention trial for Stress, Psychological focused on measuring work related stress
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group ProMES
Control group
Arm Description
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, business as usual
Outcomes
Primary Outcome Measures
Change in job strain (a measure of the balance between job demand and job control)
QPSNordic questionnaire
Secondary Outcome Measures
Change in Effort-Reward Imbalance
Effort-Reward Imbalance Questionnaire
Change in experience of stress
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.
change in sleep difficulties
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
change in Recovery
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.
change in depression
Hospital Anxiety and Depression Scale
change in Sick leave
One single question:How many working days during the last 7 days, have you been away from work because of sick leave?
change in General health
A question from General Health Questionnaire (WHO)
change in Productivity
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
change in Exhaustion
Oldenburg Burnout Inventory
Full Information
NCT ID
NCT02694211
First Posted
September 30, 2014
Last Updated
February 23, 2016
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02694211
Brief Title
Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation
Acronym
SPA
Official Title
Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation (SPA)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Stress prevention at work (SPA) project intends to evaluate the method named Productivity Measurement and Enhancement System (ProMES) as a stress preventive approach among health care employees.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
work related stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group ProMES
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention, business as usual
Intervention Type
Behavioral
Intervention Name(s)
ProMES
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in job strain (a measure of the balance between job demand and job control)
Description
QPSNordic questionnaire
Time Frame
baseline, 6-months, 12-months
Secondary Outcome Measure Information:
Title
Change in Effort-Reward Imbalance
Description
Effort-Reward Imbalance Questionnaire
Time Frame
baseline, 6-months, 12-months
Title
Change in experience of stress
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
change in sleep difficulties
Description
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
Time Frame
baseline, 6-months, 12-months
Title
change in Recovery
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
change in depression
Description
Hospital Anxiety and Depression Scale
Time Frame
baseline, 6-months, 12-months
Title
change in Sick leave
Description
One single question:How many working days during the last 7 days, have you been away from work because of sick leave?
Time Frame
baseline, 6-months, 12-months
Title
change in General health
Description
A question from General Health Questionnaire (WHO)
Time Frame
baseline, 6-months, 12-months
Title
change in Productivity
Description
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
Time Frame
baseline, 6-months, 12-months
Title
change in Exhaustion
Description
Oldenburg Burnout Inventory
Time Frame
baseline, 6-months, 12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Jensen, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation
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