A Problem Solving Intervention Involving Employees at Risk of Sick Leave Due to Common Mental Disorders

NCT04975750 | Active Not Recruiting

• 1 other identifier: 4-3084/2019
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this randomized controlled trial is to evaluate the effectiveness of a problem-solving intervention for the prevention of sick leave among employees with early signs of CMDs. The intervention is delivered by first-line managers and a 30% reduction in sick leave days is expected in the experimental condition compared to treatment-as-usual, during the 12- months follow-up.

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (1)

• Sick leave

  The total number of days on sick leave due to CMDs (including the first 14 calendar days compensated by the employer) during the 12 month follow-up period

  From baseline until 12 months

Secondary Outcomes (8)

• Work performance

  From baseline until the 12-month follow-up

• Work ability

  From baseline until the 12-month follow-up

• Self-rated general health

  From baseline until the 12-month follow-up

• Depressive and anxiety symptoms

  From baseline until the 12-month follow-up

• Self-rated exhaustion

  From baseline until the 12-month follow-up

Other Outcomes (3)

• General self-efficacy

  From baseline until the 12-month follow-up

• Manager support

  From baseline until the 12-month follow-up

• Job control

  From baseline until the 12-month follow-up

Study Arms (2)

Problem solving intervention

EXPERIMENTAL

Problem solving as developed by Nexu and colleguages. First-line managers are trained in the problem solving intervention (1 1/2 day). Thereafter, they apply the problem-solving in 2 - 5 meetings (about 30 - 45 min each) with employees at risk of future sick leave due to common mental disorders.

Behavioral: Problem solving intervention

Care as usual

ACTIVE COMPARATOR

First-line managers participate in a 3 hour lectur including a brief overview about worker health, occupational stress and the mismatch model and self-efficacy. Thereafter, they provide care-as-usual to employees at risk of future sick leave due to common mental disorders.

Behavioral: Care as usual

Interventions

Problem solving intervention BEHAVIORAL

The intervention focuses on the individual employee and his/her work situation and work-private life balance. The following steps are implemented: inventory and prioritization of problems; brainstorming options and solutions; formulation of an action plan; evaluation, and follow-up. The intervention is carried out in about 3 planned meetings (30 - 45 min) between the manager and the employee. However, given the lack of research regarding the intervention delivered to this specific population and which dose that should be considered as beneficial as well as the complexities of the identified problems, the number of meetings is not specified

Problem solving intervention

Care as usual BEHAVIORAL

The managers and the employee have meetings regarding the employee and his/her work situation and work-private life balance. However, the managers are not educated in and do not use the problem solving intervention. They are instead instructed to use their usual procedures.

Care as usual

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• scoring with a cut-off ≥3 points on the GHQ-12, or a positive answer on the question on risk of SA, namely employee believes that he/she will receive a sickness certification due to stress, anxiety, or depression the following 12 months.
• negative answer on the question on bullying, namely employee has not been exposed to bullying by his or her first line manager.
• understand written and spoken Swedish.

You may not qualify if:

• Ongoing sick leave (full- or part-time), leave of absence, pregnancy.
• Sick leave ≥14 calendar days during the last 3 months due to CMD.

Sponsors & Collaborators

• Karolinska Institutet: lead
• AFA Insurance: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

Related Publications (1)

• Bjork Bramberg E, Arapovic-Johansson B, Bultmann U, Svedberg P, Bergstrom G. Prevention of sick leave at the workplace: design of a cluster-randomized controlled trial of a problem-solving intervention among employees with common mental disorders. BMC Public Health. 2021 Sep 26;21(1):1756. doi: 10.1186/s12889-021-11786-6.

  PMID: 34565357 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Elisabeth Björk-Brämberg@ki.se, 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: Docent, Associate Professor, PhD

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: August 16, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

SE (1)