Mental DisordersPRIMENCT04975750
A Problem Solving Intervention Involving Employees at Risk of Sick Leave Due to Common Mental Disorders
A study testing Problem solving intervention and Care as usual in people with Mental Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Problem solving intervention and Care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSweden
- Study dates
- 16 Aug 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Problem solving intervention, Care as usual
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem solving interventionBehavioural
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 usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Problem solving intervention | Experimental | 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. Receives: Behavioral: Problem solving intervention |
| Care as usual | Active comparator | 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. Receives: Behavioral: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline until 12 months
Secondary outcomes (8)
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.
Measured: From baseline until the 12-month follow-up
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".
Measured: From baseline until the 12-month follow-up
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).
Measured: From baseline until the 12-month follow-up
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.
Measured: From baseline until the 12-month follow-up
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.
Measured: From baseline until the 12-month follow-up
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).
Measured: From baseline until the 12-month follow-up
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.
Measured: From baseline until the 12-month follow-up
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".
Measured: From baseline until the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start16 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- AFA Insurance
- Responsible party
- Principal investigator, Elisabeth Björk Brämberg, PhD, Karolinska Institutet
- Investigators
- Elisabeth Björk-Brämberg@ki.se, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975750
- Sponsor's protocol ID
- 4-3084/2019
- Acronym
- PRIME
- Status last verified
- Mar 2024
- First submitted
- 14 Jul 2021
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34565357
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04975750
- Acronym / sponsor ID
- PRIME / 4-3084/2019
- Conditions
- Mental Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- AFA Insurance
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem solving intervention | Experimental | Behavioral: Problem solving interventionProblem 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. |
| Care as usual | Active comparator | Behavioral: Care as usualFirst-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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem solving interventionThe 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 | Behavioural | Problem solving intervention |
| Care as usualThe 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. | Behavioural | Care as usual |
Primary outcome
Sick leave
Time frame: 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
8 secondary outcomes
Work performance
Time frame: From baseline until the 12-month follow-up
Work ability
Time frame: From baseline until the 12-month follow-up
Self-rated general health
Time frame: From baseline until the 12-month follow-up
Depressive and anxiety symptoms
Time frame: From baseline until the 12-month follow-up
Self-rated exhaustion
Time frame: From baseline until the 12-month follow-up
Psychosocial work environment
Time frame: From baseline until the 12-month follow-up
Work stress
Time frame: From baseline until the 12-month follow-up
Life-work conflict
Time frame: From baseline until the 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Derived from this study: PubMed 34565357Bjork 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Björk-Brämberg@ki.se, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem solving intervention and Care as usual in people with Mental Disorders, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sick leave (time frame: From baseline until 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04975750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.