Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation

Stress, Psychological Clinical Trial

— SPA  

Official title:

Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation (SPA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694211
• Other study ID #: 2012/2200-31/5
• Status: Completed
• Phase: N/A
• First received: September 30, 2014
• Last updated: February 23, 2016
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in job strain (a measure of the balance between job demand and job control)	QPSNordic questionnaire	baseline, 6-months, 12-months	No
Secondary	Change in Effort-Reward Imbalance	Effort-Reward Imbalance Questionnaire	baseline, 6-months, 12-months	No
Secondary	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.	baseline, 6-months, 12-months	No
Secondary	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	baseline, 6-months, 12-months	No
Secondary	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.	baseline, 6-months, 12-months	No
Secondary	change in depression	Hospital Anxiety and Depression Scale	baseline, 6-months, 12-months	No
Secondary	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?	baseline, 6-months, 12-months	No
Secondary	change in General health	A question from General Health Questionnaire (WHO)	baseline, 6-months, 12-months	No
Secondary	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	baseline, 6-months, 12-months	No
Secondary	change in Exhaustion	Oldenburg Burnout Inventory	baseline, 6-months, 12-months	No