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

Not Applicable

Active, not recruiting

• Conditions: Mental Disorders
• Interventions: Behavioral: Care as usual; Behavioral: Problem solving intervention

• Registration Number: NCT04975750
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-23
• Study Start: 2021-08-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 170

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care as usual	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.
Problem solving intervention	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.

Primary Outcome Measures

Name	Time	Method
Sick leave	From baseline until 12 months	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

Secondary Outcome Measures

Name	Time	Method
Work performance	From baseline until the 12-month follow-up	Evaluated by two items: one item about impairment of work performance due to health problems (presenteeism), and one item about impairment of work performance due to work environment problems. Karlsson ML, Bergstrom G, Bjorklund C, Hagberg J, Jensen I: Measuring production loss due to health and work environment problems: construct validity and implications. J Occup Environ Med 2013, 55(12):1475-1483.; Scale ranging from 0 to 10, higher scores indicate worse outcome.
Self-rated general health	From baseline until the 12-month follow-up	Measured with a single item from the Short-Form Health Survey, with a five-point response scale, ranging from 1 (excellent) to 5 (bad).
Work ability	From baseline until the 12-month follow-up	Measured by three items of the Work Ability Index (WAI) Perceived work ability in relation to physcial and mental demands of the work are measured by a five-point scale, ranging from "very bad" to "excellent".; The employee's beliefs about workability is measured by a three-point sca,e ranging from "unlikely" to "relatively certain".
Depressive and anxiety symptoms	From baseline until the 12-month follow-up	Severity of depressive and anxiety symptoms are assessed by the Hospital Anxiety and Depression Scale.; The response format is a 4-point scale, ranging from 0 to 3, with higher scores indicating higher levels of depressive or anxiety symptoms.
Self-rated exhaustion	From baseline until the 12-month follow-up	Assessed by four items of the Self-rated exhaustion disorder (s-ED) scale, with the response format yes/no. Reference: Glise K, Hadzibajramovic E, Jonsdottir IH, Ahlborg G Jr. Self-reported exhaustion: a possible indicator of reduced work ability and increased risk of sickness absence among human service workers. Int Arch Occup Environ Health. 2010 Jun;83(5):511-20. doi: 10.1007/s00420-009-0490-x. Epub 2009 Nov 27. PMID: 19943058.
Psychosocial work environment	From baseline until the 12-month follow-up	The Copenhagen Psychosocial Questionnaire (COPSOQ) III, Swedish standard version, is used for assessing demands at work (3 questions quantitative and 3 questions emotional demands, responses are given on a five-point scale ranging from Always (100) to Never/hardly ever (0). Higher scores mean a worse outcome); for assessing interpersonal relations and leadership (2 questions recognition and 3 questions quality of leadership, responses are given on a five-point scale from To a very large extent (100) to To a very small extent, Higher scores mean a better outcome), and for assessing work-individual interface (3 questions commitment to the workplace and 3 questions work-life conflict, responses are given on a five-point scale from To a very large extent (100) to To a very small extent, Higher scores mean a better outcome for Commitment to the workplace, while higher scores mean a worse outcome for Work-life conflict).
Work stress	From baseline until the 12-month follow-up	Single Item stress question (SISQ) with a five-poing response scale ranging from 1 ("not at all") to 5 ("very much"). Arapovic-Johansson B, Wåhlin C, Kwak L, Björklund C, Jensen I: Work-related stress assessed by a text message single-item stress question. Occupational medicine (Oxford, England) 2017, 67(8):601-608.
Life-work conflict	From baseline until the 12-month follow-up	Impact of private life on work is measured by a single item question from the General Nordic Questionnaire with the response anchors "Very seldom or never" to "very often or always".

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden