A Problem Solving Intervention Involving Employees at Risk of Sick Leave Due to Common Mental Disorders (PRIME)
Primary Purpose
Mental Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Problem solving intervention
Care as usual
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders
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).
Sites / Locations
- Karolinska InstitutetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Problem solving intervention
Care as usual
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Work performance
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.
Work ability
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".
Self-rated general health
Measured with a single item from the Short-Form Health Survey, with a five-point response scale, ranging from 1 (excellent) to 5 (bad).
Depressive and anxiety symptoms
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
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
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
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
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".
Full Information
NCT ID
NCT04975750
First Posted
July 14, 2021
Last Updated
August 16, 2021
Sponsor
Karolinska Institutet
Collaborators
AFA Insurance
1. Study Identification
Unique Protocol Identification Number
NCT04975750
Brief Title
A Problem Solving Intervention Involving Employees at Risk of Sick Leave Due to Common Mental Disorders
Acronym
PRIME
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
AFA Insurance
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Problem solving intervention
Arm Type
Experimental
Arm 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.
Arm Title
Care as usual
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Problem solving intervention
Intervention Description
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
Intervention Name(s)
Care as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sick leave
Description
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
Time Frame
From baseline until 12 months
Secondary Outcome Measure Information:
Title
Work performance
Description
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.
Time Frame
From baseline until the 12-month follow-up
Title
Work ability
Description
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".
Time Frame
From baseline until the 12-month follow-up
Title
Self-rated general health
Description
Measured with a single item from the Short-Form Health Survey, with a five-point response scale, ranging from 1 (excellent) to 5 (bad).
Time Frame
From baseline until the 12-month follow-up
Title
Depressive and anxiety symptoms
Description
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.
Time Frame
From baseline until the 12-month follow-up
Title
Self-rated exhaustion
Description
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.
Time Frame
From baseline until the 12-month follow-up
Title
Psychosocial work environment
Description
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).
Time Frame
From baseline until the 12-month follow-up
Title
Work stress
Description
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.
Time Frame
From baseline until the 12-month follow-up
Title
Life-work conflict
Description
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".
Time Frame
From baseline until the 12-month follow-up
Other Pre-specified Outcome Measures:
Title
General self-efficacy
Description
The employee's beliefs in his/her ability to cope with the current situation, mobilize motivation and to act upon demands in different situations, measured by a Swedish validated version of General self-efficacy scale, responses are given on a four-point scale ranging from 1 ("not at all true" to 4 ("exacly true"). Reference: Love J, Moore CD, Hensing G: Validation of the Swedish translation of the General Self-Efficacy scale. Qual Life Res 2012, 21(7):1249-1253.) as well as by a single item measure of general self-efficacy (Williams G, Smith A: Using Single-Item Measures to Examine the Relationships between Work, Personality, and Well-Being in the Workplace. Psychology 2016, 7(6):753-767.
Time Frame
From baseline until the 12-month follow-up
Title
Manager support
Description
Measured by the two questions of the Social support from supervisor subscale from the The Copenhagen Psychosocial Questionnaire (COPSOQ) III, Swedish standard version. Responses are given on a five-point scale ranging from Always (100) to never/hardly ever (0). Higher scores mean a better outcome.
Time Frame
From baseline until the 12-month follow-up
Title
Job control
Description
Job control is measured by the four questions of the Influence at work subscale from The Copenhagen Psychosocial Questionnaire (COPSOQ) III, Swedish standard version. Responses are given on a five-point scale ranging from Always (100) to Never/hardly ever (0). Higher scores mean a better outcome.
Time Frame
From baseline until the 12-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Björk-Brämberg, PhD
Phone
+46709221063
Email
elisabeth.bjork.bramberg@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Bozana Arapovic-Johansson, PhD
Phone
+46730348169
Email
bozana.johansson@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Björk-Brämberg@ki.se, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth B Brämberg, PhD
Phone
0046852487412
Email
elisabeth.bjork.bramberg@ki.se
First Name & Middle Initial & Last Name & Degree
Bozana A Johansson, PhD
Email
bozana.johansson@ki.se
12. IPD Sharing Statement
Citations:
PubMed Identifier
34565357
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.
Results Reference
derived
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A Problem Solving Intervention Involving Employees at Risk of Sick Leave Due to Common Mental Disorders
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