Stress and Mental Ill-health in the Workplace: Evaluation of an Intervention for the Prevention of Sick Leave

NCT ID: NCT02563743

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-25

Study Completion Date

2020-05-30

Brief Summary

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Purpose

Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden, resulting in suffering for the individual and financial costs for the employer as well as for society at large. Studies on interventions that address stress and mental ill-health and that focus on sick leave and return to work (RTW) show little or no effect of commonly used methods such as medication or psychological approaches. Furthermore, these interventions often focus on the individual's symptoms without considering their work situation. The occupational health services (OHS) has knowledge of the employee's work environment and can offer treatment facilitating the employee's RTW and improving the employee's work ability while taking into account both the individual and the work situation. The intervention in the current study will be performed at the OHS.

The study aim is two-fold: first, an intervention that addresses both individual and workplace related aspects among employees with work-related CMD:s and/or stress related symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence to the intended treatment and associations with the outcome of the intervention will be assessed.

Detailed Description

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Conditions

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Common Mental Disorders and/or Stress Related Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Problem-solving based intervention

Problem-solving based intervention with a participative approach. During the intervention a systematic assessment of the match between the employee and the work environment is considered. The intervention applies a participatory approach where the supervisor and the employee are guided by the OHS consultant and encouraged to actively take part in problem solving concerning the work situation. The intervention consists of three meetings, one between the OHS consultant and a representative for the employer (usually the nearest supervisor), one between the consultant and the employee and then a third meeting where all three parties participate.

Group Type EXPERIMENTAL

Problem-solving based intervention

Intervention Type BEHAVIORAL

The intervention comprises both the employee and the employer, and follows a clear structure comprising problem solving, stepwise activation and relapse prevention. It includes three meetings at the OHS with additional follow-ups.

Treatment as usual

The control intervention consists of the usual interventions given at the participating OHS. These interventions are also work-directed and usually also include participation of both the employee and the supervisor. However, structured problem solving methods and the systematic consideration of the match between the employee and the job situation are not applied. The content of the control condition will vary between different occupational health service units.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Study participants that are randomized into the control group will receive the usual care given at the OHS. This intervention will differ due to differences between the OHS units.

Interventions

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Problem-solving based intervention

The intervention comprises both the employee and the employer, and follows a clear structure comprising problem solving, stepwise activation and relapse prevention. It includes three meetings at the OHS with additional follow-ups.

Intervention Type BEHAVIORAL

Treatment as usual

Study participants that are randomized into the control group will receive the usual care given at the OHS. This intervention will differ due to differences between the OHS units.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The employee suffers from stress related symptoms or work-related common mental disorders.
* The employee is either not on sick leave or is on sick leave for a maximum of 3 consecutive months (full or part time).
* The employee understands both written and spoken Swedish.
* The employees nearest supervisor should be aware of the employees visit(s) at the OHS (to avoid differential selection into the experimental and the control condition)

Exclusion Criteria

* Bullying
* Pregnancy
* Post traumatic stress-disorder
* Severe mental disorders (e.g. psychosis)
* Any co-morbidity that may substantially affect the employee's ability to work and/or quality of life.
Minimum Eligible Age

18 Years

Maximum Eligible Age

63 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Gunnar Bergström

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunnar Bergström, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Bergstrom G, Lohela-Karlsson M, Kwak L, Bodin L, Jensen I, Torgen M, Nybergh L. Preventing sickness absenteeism among employees with common mental disorders or stress-related symptoms at work: Design of a cluster randomized controlled trial of a problem-solving based intervention versus care-as-usual conducted at the Occupational Health Services. BMC Public Health. 2017 May 12;17(1):436. doi: 10.1186/s12889-017-4329-1.

Reference Type BACKGROUND
PMID: 28494753 (View on PubMed)

Keus van de Poll M, Nybergh L, Lornudd C, Hagberg J, Bodin L, Kwak L, Jensen I, Lohela-Karlsson M, Torgen M, Bergstrom G. Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services. Occup Environ Med. 2020 Jul;77(7):454-461. doi: 10.1136/oemed-2019-106353. Epub 2020 Apr 14.

Reference Type BACKGROUND
PMID: 32291291 (View on PubMed)

Keus Van De Poll M, Bergstrom G, Jensen I, Nybergh L, Kwak L, Lornudd C, Lohela-Karlsson M. Cost-Effectiveness of a Problem-Solving Intervention Aimed to Prevent Sickness Absence among Employees with Common Mental Disorders or Occupational Stress. Int J Environ Res Public Health. 2020 Jul 20;17(14):5234. doi: 10.3390/ijerph17145234.

Reference Type BACKGROUND
PMID: 32698470 (View on PubMed)

Toropova A, Bjork Bramberg E, Bergstrom G. Return to Work Trajectories of Swedish Employees on Sick-Leave Due to Common Mental Disorders. J Occup Rehabil. 2025 Sep;35(3):479-490. doi: 10.1007/s10926-024-10216-9. Epub 2024 Jun 22.

Reference Type DERIVED
PMID: 38907784 (View on PubMed)

Other Identifiers

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2014-0742

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

4-2544/2014

Identifier Type: -

Identifier Source: org_study_id

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