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

NCT ID: NCT04975750

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2024-12-31

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.

Detailed Description

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.

In an alongside process evaluation on the intervention's core activities, i.e. identification of early signs of CMDs, training of first-line managers in problem-solving and communication, we will:

• evaluate whether and to what extent it was possible for the first-line managers to adhere to the intervention's protocol,
• investigate the association between the intervention's core activities and number of sick leave days,
• identify the facilitators and barriers to the intervention among first-line managers and employees and,
• explore the first-line manager's organizational resources supporting their general managerial work.

The study will be conducted in private sector companies, among first-line managers and blue-collar workers. The outcomes will be evaluated on both cluster- and individual participant level.

Conditions

Mental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Problem solving intervention

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.

Group Type: EXPERIMENTAL

Problem solving intervention

Intervention Type: 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

Care as usual

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.

Group Type: ACTIVE_COMPARATOR

Care as usual

Intervention Type: 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.

Interventions

Problem solving intervention

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

Intervention Type: BEHAVIORAL

Care as usual

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Ongoing sick leave (full- or part-time), leave of absence, pregnancy.
• Sick leave ≥14 calendar days during the last 3 months due to CMD.
• At the time for inclusion planned long-term absence during the coming year (for example parental leave, new job, retirement).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AFA Insurance

INDUSTRY

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth Björk Brämberg, PhD

Docent, Associate Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisabeth Björk-Brämberg@ki.se, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 34565357 (View on PubMed)

Other Identifiers

4-3084/2019

Identifier Type: -

Identifier Source: org_study_id