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

NCT02563743 | Completed

• 2 other identifiers: 4-2544/20142014-0742
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Mental Disorders and/or Stress Related Symptoms

Keywords

Sick-leave; Return to work; Occupational health; Common mental disorder; Depression; Anxiety disorders; Adjustment disorders; Problem solving therapy; Occupational Health Services; Randomized controlled trial; Intervention studies; Occupational stress

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period.

  (1) Total sick leave in days, register data (sickness benefit and disability pension). Sickness benefit and disability pension will also be analyzed separately. The analyses will be repeated for outcomes on registered sick leave at a three-years follow-up

  At baseline and 12 months after baseline.

Secondary Outcomes (26)

• Change from baseline in self-reported sickness absenteeism during the 12 months follow-up period

  At baseline and during monthly follow-ups for a period of 12 months

• The prevalence of no sick leave, part-time sick leave and full-time sick leave during the 12 months follow-up period following baseline

  Twelve months after baseline

• Among those sick listed at baseline: Time to full Return to Work (RTW) during a follow-up period of 12 months

  At baseline and during monthly follow-ups for a period of 12 months

• Among those sick listed at baseline: Time to Return to Work (RTW) during a follow-up period of 12 months

  At baseline and during monthly follow-ups for a period of 12 months

• Work performance impairment due to health problems

  Will be assessed at baseline and once a month during a 12-month follow-up period

Study Arms (2)

Problem-solving based intervention

EXPERIMENTAL

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.

Behavioral: Problem-solving based intervention

Treatment as usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment as usual

Interventions

Problem-solving based intervention 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.

Problem-solving based intervention

Treatment as usual 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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 14141, Sweden

Location

Related Publications (4)

• 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.

  PMID: 28494753 BACKGROUND

• 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.

  PMID: 32291291 BACKGROUND

• 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.

  PMID: 32698470 BACKGROUND

• 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.

  PMID: 38907784 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Adjustment Disorders; Occupational Stress

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Trauma and Stressor Related Disorders; Occupational Diseases; Stress, Psychological

Study Officials

• Gunnar Bergström, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 30, 2015
• Study Start: August 25, 2015
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

SE (1)