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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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological focused on measuring work related stress

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 30, 2014
    Last Updated
    February 23, 2016
    Sponsor
    Karolinska Institutet
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    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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