Clinical trial NCT04975750: A Problem Solving Intervention Involving Employees at Risk of Sick Leave Due to Common Mental Disorders
Official title: Early 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: AFA Insurance
First posted: 2021-07-23
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Sick leave
timeFrame: From baseline until 12 months
Secondary outcomes:
measure: Work performance
timeFrame: From baseline until the 12-month follow-up
measure: Work ability
timeFrame: From baseline until the 12-month follow-up
measure: Self-rated general health
timeFrame: From baseline until the 12-month follow-up
measure: Depressive and anxiety symptoms
timeFrame: From baseline until the 12-month follow-up
measure: Self-rated exhaustion
timeFrame: From baseline until the 12-month follow-up
measure: Psychosocial work environment
timeFrame: From baseline until the 12-month follow-up
measure: Work stress
timeFrame: From baseline until the 12-month follow-up
measure: Life-work conflict
timeFrame: From baseline until the 12-month follow-up
Other outcomes:
measure: General self-efficacy
timeFrame: From baseline until the 12-month follow-up
measure: Manager support
timeFrame: From baseline until the 12-month follow-up
measure: Job control
timeFrame: From baseline until the 12-month follow-up
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Elisabeth Björk-Brämberg@ki.se, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.