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

Karolinska Institute

Status: Active, not recruiting

Conditions: Mental Disorders

Treatments: Behavioral: Care as usual; Behavioral: Problem solving intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04975750

4-3084/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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170 participants in 2 patient groups

Problem solving intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Problem solving intervention

Care as usual

Active Comparator group

Description:

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.

Treatment:

Behavioral: Care as usual