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CompletedNCT02694211SPAUpdated Feb 29, 2016

Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation

An interventional study of ProMES in Stress, Psychological, sponsored by Karolinska Institutet. Completed. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2016-02-29.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 67 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Stress, Psychological

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Keywords

  • work related stress
03

In context

Stress, Psychological

783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.

This study's enrollment of 130 is above the median of 85 across 632 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • employees absent due to long-term illness,
  • employees absent due to parental leave
  • employees absent due to long-term studies
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • 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

    Behavioral: ProMES

  • No intervention
    Control group

    No intervention, business as usual

Interventions

  • BehavioralProMES

    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

06

What researchers measure

Primary outcomes

  1. Change in job strain (a measure of the balance between job demand and job control)

    QPSNordic questionnaire

    Time frame: baseline, 6-months, 12-months

Secondary outcomes

  1. Change in Effort-Reward Imbalance

    Effort-Reward Imbalance Questionnaire

    Time frame: baseline, 6-months, 12-months

  2. 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.

    Time frame: baseline, 6-months, 12-months

  3. 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

    Time frame: baseline, 6-months, 12-months

  4. 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.

    Time frame: baseline, 6-months, 12-months

  5. change in depression

    Hospital Anxiety and Depression Scale

    Time frame: baseline, 6-months, 12-months

  6. 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?

    Time frame: baseline, 6-months, 12-months

  7. change in General health

    A question from General Health Questionnaire (WHO)

    Time frame: baseline, 6-months, 12-months

  8. 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

    Time frame: baseline, 6-months, 12-months

  9. change in Exhaustion

    Oldenburg Burnout Inventory

    Time frame: baseline, 6-months, 12-months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02694211
Lead sponsor
Karolinska Institutet
Responsible party
Irene Jensen (Professor, Karolinska Institutet) — Principal investigator
First posted
Feb 29, 2016
Start date
May 2013
Primary completion
Oct 2014
Completion
Jan 2015
Last update
Feb 29, 2016

Study contacts

Irene Jensen, Professor
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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