NCT02480855

Brief Summary

A vital question for society in general and primary health care in particular is early identification of persons at risk of sickness absence due to work-related stress. Even though both the individual and society can gain a lot from the prevention of absence, not the least since return to work is costly once a person is sick-listed. There is, surprisingly enough, no established method to do this. This project is a randomized controlled study of people with mental disorders and physical complaints consulting primary care. The purpose is to evaluate if a systematic use of early identification of work-related stress, combined with feedback at consultation, at the primary health care centers can prevent sickness absence among employed women and men with common mental disorders and subjective physical health complaints.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

2.5 years

First QC Date

May 20, 2015

Last Update Submit

November 2, 2018

Conditions

Keywords

work related stressquestionnaireearly identification

Outcome Measures

Primary Outcomes (2)

  • Number of sick-leave days.

    Differences in number of sick-leave days between intervention group and control group.

    12 months after inclusion

  • Number of periods of sick-leave, full-time or part-time.

    Differences in number of sick-leave periods, full-time or part-time between intervention group and control group.

    12 months after inclusion

Secondary Outcomes (4)

  • Number of health care treatments.

    12 months after inclusion

  • Types of health care treatments.

    12 months after inclusion

  • Number of medicines prescriptions.

    12 months after inclusion

  • Types of medicines prescriptions.

    12 months after inclusion

Study Arms (2)

Questionnaire and feedback

OTHER

Patients that will see a doctor randomized to the intervention group will fill in the Work Stress Questionnaire prior to the visit. The doctor gets the results from the questionnaire and then gives consultation to the patient based on the results.

Other: Questionnaire and feedback

Control group

NO INTERVENTION

Patients that will see a doctor randomized to the control group get the usual treatment/consultation and after the visit fill in the Work Stress Questionnaire.

Interventions

Questionnaire and feedback

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Employed women and men, aged 18 - 64 years
  • Seeking care for:
  • depression
  • anxiety
  • musculoskeletal disorders
  • gastrointestinal and cardio-vascular symptoms
  • other stress-related symptoms

You may not qualify if:

  • Currently on sick-leave or have been on sick-leave with doctor's certificate the last month
  • Have been absent from work due to illness more than 7 days the last month (without doctor's certificate)
  • On sickness or activity payments
  • Pregnant women
  • Patients seeking care for:
  • allergy
  • diabetes
  • urinary tract infection
  • infections (whooping cough, tonsillitis)
  • COPD
  • fractures
  • lumps and spots
  • psychiatric diagnoses such as schizophrenia, other psychoses or bipolar diagnoses
  • prolonging of sick-leave certificate
  • check up of chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Hulten AM, Bjerkeli P, Holmgren K. Work-related stress and future sick leave in a working population seeking care at primary health care centres: a prospective longitudinal study using the WSQ. BMC Public Health. 2022 Apr 28;22(1):851. doi: 10.1186/s12889-022-13269-8.

  • Hulten AM, Bjerkeli P, Holmgren K. Self-reported sick leave following a brief preventive intervention on work-related stress: a randomised controlled trial in primary health care. BMJ Open. 2021 Mar 22;11(3):e041157. doi: 10.1136/bmjopen-2020-041157.

  • Hulten AM, Dahlin-Ivanoff S, Holmgren K. Positioning work related stress - GPs' reasoning about using the WSQ combined with feedback at consultation. BMC Fam Pract. 2020 Sep 11;21(1):187. doi: 10.1186/s12875-020-01258-y.

  • Sandheimer C, Hedenrud T, Hensing G, Holmgren K. Effects of a work stress intervention on healthcare use and treatment compared to treatment as usual: a randomised controlled trial in Swedish primary healthcare. BMC Fam Pract. 2020 Jul 6;21(1):133. doi: 10.1186/s12875-020-01210-0.

  • Bjerkeli PJ, Skoglund I, Holmgren K. Does early identification of high work related stress affect pharmacological treatment of primary care patients? - analysis of Swedish pharmacy dispensing data in a randomised control study. BMC Fam Pract. 2020 Apr 25;21(1):70. doi: 10.1186/s12875-020-01140-x.

  • Holmgren K, Hensing G, Bultmann U, Hadzibajramovic E, Larsson MEH. Does early identification of work-related stress, combined with feedback at GP-consultation, prevent sick leave in the following 12 months? a randomized controlled trial in primary health care. BMC Public Health. 2019 Aug 14;19(1):1110. doi: 10.1186/s12889-019-7452-3.

  • Holmgren K, Sandheimer C, Mardby AC, Larsson ME, Bultmann U, Hange D, Hensing G. Early identification in primary health care of people at risk for sick leave due to work-related stress - study protocol of a randomized controlled trial (RCT). BMC Public Health. 2016 Nov 25;16(1):1193. doi: 10.1186/s12889-016-3852-9.

MeSH Terms

Conditions

Occupational Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kristina Holmgren, Docent

    Section for Rehabilitation and Health, Inst for neuro science and physiology, Sahlgrenska academy, University of Gothenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

June 25, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 6, 2018

Record last verified: 2018-11