Common Mental Disorders and/or Stress Related SymptomsNCT02563743
Stress and Mental Ill-health in the Workplace: Evaluation of an Intervention for the Prevention of Sick Leave
A study testing Problem-solving based intervention and Treatment as usual in people with Common Mental Disorders and/or Stress Related Symptoms, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Purpose Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden, resulting in suffering for the individual and financial costs for the employer as well as for society at large. Read more about this study
- Who is it for?
- Ages 18 to 63 years
- Conditions the study is for
- Common Mental Disorders and/or Stress Related Symptoms
- What is being tested?
- Problem-solving based intervention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 25 Aug 2015to 30 May 2020
- 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 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The employee suffers from stress related symptoms or work-related common mental disorders.
- The employee is either not on sick leave or is on sick leave for a maximum of 3 consecutive months (full or part time).
- The employee understands both written and spoken Swedish.
- The employees nearest supervisor should be aware of the employees visit(s) at the OHS (to avoid differential selection into the experimental and the control condition)
Who cannot join
- Bullying
- Pregnancy
- Post traumatic stress-disorder
- Severe mental disorders (e.g. psychosis)
- Any co-morbidity that may substantially affect the employee's ability to work and/or quality of life.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Sickness Absenteeism Among Employees With Common Mental Disorders and Stress-related Symptoms: a Cluster Randomized Trial of a Problem-solving Based Intervention Versus Care-as-usual Conducted at the Occupational Health Services
Purpose
Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden, resulting in suffering for the individual and financial costs for the employer as well as for society at large. Studies on interventions that address stress and mental ill-health and that focus on sick leave and return to work (RTW) show little or no effect of commonly used methods such as medication or psychological approaches. Furthermore, these interventions often focus on the individual's symptoms without considering their work situation. The occupational health services (OHS) has knowledge of the employee's work environment and can offer treatment facilitating the employee's RTW and improving the employee's work ability while taking into account both the individual and the work situation. The intervention in the current study will be performed at the OHS.
The study aim is two-fold: first, an intervention that addresses both individual and workplace related aspects among employees with work-related CMD:s and/or stress related symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence to the intended treatment and associations with the outcome of the intervention will be assessed.
- Being tested
- Problem-solving based intervention, Treatment as usual
- Keywords
- Sick-leave, Return to work, Occupational health, Common mental disorder, Depression, Anxiety disorders, Adjustment disorders, Problem solving therapy, Occupational Health Services, Randomized controlled trial, Intervention studies, Occupational stress
- Medical subject headings
- Depression, Anxiety Disorders, Adjustment Disorders, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-solving based interventionBehavioural
The intervention comprises both the employee and the employer, and follows a clear structure comprising problem solving, stepwise activation and relapse prevention. It includes three meetings at the OHS with additional follow-ups.
Treatment as usualBehavioural
Study participants that are randomized into the control group will receive the usual care given at the OHS. This intervention will differ due to differences between the OHS units.
| Study group | Role | What they receive |
|---|---|---|
| Problem-solving based intervention | Experimental | Problem-solving based intervention with a participative approach. During the intervention a systematic assessment of the match between the employee and the work environment is considered. The intervention applies a participatory approach where the supervisor and the employee are guided by the OHS consultant and encouraged to actively take part in problem solving concerning the work situation. The intervention consists of three meetings, one between the OHS consultant and a representative for the employer (usually the nearest supervisor), one between the consultant and the employee and then a third meeting where all three parties participate. Receives: Behavioral: Problem-solving based intervention |
| Treatment as usual | Active comparator | The control intervention consists of the usual interventions given at the participating OHS. These interventions are also work-directed and usually also include participation of both the employee and the supervisor. However, structured problem solving methods and the systematic consideration of the match between the employee and the job situation are not applied. The content of the control condition will vary between different occupational health service units. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period.
(1) Total sick leave in days, register data (sickness benefit and disability pension). Sickness benefit and disability pension will also be analyzed separately.
The analyses will be repeated for outcomes on registered sick leave at a three-years follow-up
Measured: At baseline and 12 months after baseline.
Secondary outcomes (26)
Change from baseline in self-reported sickness absenteeism during the 12 months follow-up period
Self-report data obtained every four weeks during the 12-months follow-up period. These data also include short spells of sick leave.
Possible interaction effects on the primary and secondary outcomes for (1) gender x treatment (intervention) and (2) sick leave status (sick leave/no sick leave) x treatment will be checked for and if statistically significant subgroup analyses will be considered.
Measured: At baseline and during monthly follow-ups for a period of 12 months
The prevalence of no sick leave, part-time sick leave and full-time sick leave during the 12 months follow-up period following baseline
Change from baseline in self-reported data (no sick leave, 25%, 50%, 75% or 100% sick leave) obtained every fourth week during a follow-up period of 12 months
Measured: Twelve months after baseline
Among those sick listed at baseline: Time to full Return to Work (RTW) during a follow-up period of 12 months
RTW will be calculated from the study inclusion date until the individual returns in ordinary hours of work during an uninterrupted period of at least four weeks. Self-reported data obtained every fourth week during a follow-up period of 12 months.
Measured: At baseline and during monthly follow-ups for a period of 12 months
Among those sick listed at baseline: Time to Return to Work (RTW) during a follow-up period of 12 months
RTW will be calculated from the study inclusion date until the individual returns to work in any increased level (25%, 50%, 75% or 100%). Self-reported data obtained every fourth week during a follow-up period of 12 months.
Measured: At baseline and during monthly follow-ups for a period of 12 months
Work performance impairment due to health problems
Change from baseline in work performance as assessed by a question based on one item from the Work Productivity Activity Impairment - General Health Questionnaire (response format from 0-10).
Measured: Will be assessed at baseline and once a month during a 12-month follow-up period
Work performance impairment due to problems in working environment
Change from baseline in work performance as assessed by a question based on one item from the Work Productivity Activity Impairment - General Health Questionnaire (response format from 0-10).
Measured: Will be assessed at baseline and every other month (eighth weeks intervals) during a 12-month follow-up period
Cost-effectiveness of the intervention compared to treatment as usual.
The cost-effectiveness of the intervention will be calculated with regard to production loss (sick leave and performance while at work).
Measured: At 12 months after baseline
Work satisfaction
Change from baseline in self-reported work satisfaction will be assessed by a single item (response format from 0-10).
Measured: Will be assessed at baseline and after 6 and 12 months.
Work ability index (WAI)
Change from baseline in self-reported work ability as assessed by two items from WAI (response format from 1-5). The items relate to perceived capacity to work relative to the physical (1 item) and mental (1 item) demands of the work.
Measured: Will be assessed at baseline and after 6 and 12-months of study inclusion.
Sickness presenteeism
Change from baseline in sickness presenteeism is assessed with a single question (response format from 1-4).
Measured: Will be assessed at baseline and after 6 and 12-months of study inclusion.
The Institute of Stress Medicine's instrument for self-rating of stress-related Exhaustion Disorder (s-ED)
Change from baseline in self-reported exhaustion on the s-UMS (two yes/no items and one item with a response format from 0-2.
Measured: Will be assessed at baseline and after 6 and 12-months of study inclusion.
Maslach Burnout Inventory - General Survey, Exhaustion-scale
Change from baseline in self-reported exhaustion as assessed by the MBI-GS's exhaustion scale (response format from 0 to 6).
Measured: Will be assessed at baseline and after 6 and 12-months of study inclusion.
Hospital Anxiety and Depression Scale
Change from baseline in self-reported mental health as assessed by the Hospital Anxiety and Depression Scale (response format from 0-3).
Measured: Will be assessed at baseline and after 6 and 12-months of study inclusion.
Self-perceived health
Change from baseline in self-perceived health will be assessed with a single question (response format from 1-5).
Measured: Will be assessed at baseline and after 6 and 12-months of study inclusion.
European Quality of Life - 5 Dimensions questionnaire (EQ-5D)
Change from baseline in self-assessed health as assessed by EQ-5D (response format from 1-3).
Measured: Will be measured at baseline and after 6 and 12-months of study inclusion.
Self-reported stress
Change from baseline in self-reported stress as assessed by a single item (response format from 1-5).
Measured: At baseline and every other month (eighth weeks intervals) during a follow-up period of 12 months
Karolinska Sleep Questionnaire, Insomnia sub-scale
Change from baseline in self-assessed sleeping problems as assessed by the Insomnia subscale of the Karolinska Sleep Questionnaire (response format from 1-6).
Measured: Will be measured at baseline and after 6 and 12-months of study inclusion.
Demand-control-support model. Prognostic variable.
Change from Baseline at 6 and 12 months (response format from 1-4).
Measured: Baseline and at 6 and 12 months of study inclusion
Other work related variables such as ongoing conflicts with the superior, perceived loss of control over work tasks and conflicts between the employee´s values and how the work actually is done. Prognostic variables.
Change from baseline at 6 and 12 months after baseline (Likert-type scales with 3 to 5 response options).
Measured: Baseline and at 6 months after study inclusion
Physical activity. Prognostic variable.
Physical activity will be assessed by a single item. Response options: 0 minutes, less than 30 minutes, 30-60 minutes, 60-90 minutes, 90-120 minutes or more than 120 minutes.
Measured: At 6 and 12 months after intervention
Change in work conditions. Prognostic variable.
Possible changes to the participant's work conditions will be asked by a single item with 12 choices.
Measured: At 6 and 12 months after intervention
Change in the organization. Prognostic variable.
Possible changes in the organization over the past six months are assessed with four response options.
Measured: At 6 and 12 months after intervention
Participants' satisfaction and experiences with the intervention or treatment as usual will be assessed at 6 months after completed intervention by eleven items (response format from 0-10 or yes/no/do not know). Process evaluation data.
These items referred to aspects such as quality of the communication with the OHS personnel, relevance of the intervention, perceived problem-solving skills learned during the intervention, planned adjustments at work, agreement with the supervisor, the implementation of planned adjustments, if follow-up contacts with the OHS have been undertaken and questions regarding treatment satisfaction).
Measured: Will be assessed 6 months after intervention.
OHS staff's adherence to the intervention (process evaluation data)
Self-reported data, single items.
Measured: Assessed at the end of the 12-18 months long recruitment period
Implementation of the intervention and entire research project at the OHS units (process evaluation data)
Self-report data, single items and focus group interviews
Measured: Assessed at the end of the 12-18 months long recruitment period
Three years follow-up: Change from Baseline in registered sickness absenteeism during a 3-year follow-up period
Total sick leave in days, register data (sickness benefit and disability pension).
The analyses will be conducted in accordance with the 12-month follow-up.
Measured: At baseline and 3 years after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start25 Aug 2015
- Primary completion30 May 2018
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Common Mental Disorders and/or Stress Related SymptomsStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunnar Bergström, Karolinska Institutet
- Investigators
- Gunnar Bergström, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563743
- Sponsor's protocol ID
- 4-2544/2014
- Other IDs
- 2014-0742
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2015
- Last updated
- 13 Sep 2021
- Results posted
- No
Publications
Bergstrom G, Lohela-Karlsson M, Kwak L, Bodin L, Jensen I, Torgen M, Nybergh L. Preventing sickness absenteeism among employees with common mental disorders or stress-related symptoms at work: Design of a cluster randomized controlled trial of a problem-solving based intervention versus care-as-usual conducted at the Occupational Health Services. BMC Public Health. 2017 May 12;17(1):436. doi: 10.1186/s12889-017-4329-1.
PubMed 28494753Keus van de Poll M, Nybergh L, Lornudd C, Hagberg J, Bodin L, Kwak L, Jensen I, Lohela-Karlsson M, Torgen M, Bergstrom G. Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services. Occup Environ Med. 2020 Jul;77(7):454-461. doi: 10.1136/oemed-2019-106353. Epub 2020 Apr 14.
PubMed 32291291Keus Van De Poll M, Bergstrom G, Jensen I, Nybergh L, Kwak L, Lornudd C, Lohela-Karlsson M. Cost-Effectiveness of a Problem-Solving Intervention Aimed to Prevent Sickness Absence among Employees with Common Mental Disorders or Occupational Stress. Int J Environ Res Public Health. 2020 Jul 20;17(14):5234. doi: 10.3390/ijerph17145234.
PubMed 32698470Toropova A, Bjork Bramberg E, Bergstrom G. Return to Work Trajectories of Swedish Employees on Sick-Leave Due to Common Mental Disorders. J Occup Rehabil. 2025 Sep;35(3):479-490. doi: 10.1007/s10926-024-10216-9. Epub 2024 Jun 22.
PubMed 38907784
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Sickness Absenteeism Among Employees With Common Mental Disorders and Stress-related Symptoms: a Cluster Randomized Trial of a Problem-solving Based Intervention Versus Care-as-usual Conducted at the Occupational Health Services
- ClinicalTrials.gov ID
- NCT02563743
- Acronym / sponsor ID
- 4-2544/2014
- Keywords
- Sick-leave, Return to work, Occupational health, Common mental disorder, Depression, Anxiety disorders, Adjustment disorders, Problem solving therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 25 Aug 2015 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 30 Sep 2015 (estimated)
- 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.
Purpose
Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden, resulting in suffering for the individual and financial costs for the employer as well as for society at large. Studies on interventions that address stress and mental ill-health and that focus on sick leave and return to work (RTW) show little or no effect of commonly used methods such as medication or psychological approaches. Furthermore, these interventions often focus on the individual's symptoms without considering their work situation. The occupational health services (OHS) has knowledge of the employee's work environment and can offer treatment facilitating the employee's RTW and improving the employee's work ability while taking into account both the individual and the work situation. The intervention in the current study will be performed at the OHS.
The study aim is two-fold: first, an intervention that addresses both individual and workplace related aspects among employees with work-related CMD:s and/or stress related symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence to the intended treatment and associations with the outcome of the intervention will be assessed.
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 based intervention | Experimental | Behavioral: Problem-solving based interventionProblem-solving based intervention with a participative approach. During the intervention a systematic assessment of the match between the employee and the work environment is considered. The intervention applies a participatory approach where the supervisor and the employee are guided by the OHS consultant and encouraged to actively take part in problem solving concerning the work situation. The intervention consists of three meetings, one between the OHS consultant and a representative for the employer (usually the nearest supervisor), one between the consultant and the employee and then a third meeting where all three parties participate. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualThe control intervention consists of the usual interventions given at the participating OHS. These interventions are also work-directed and usually also include participation of both the employee and the supervisor. However, structured problem solving methods and the systematic consideration of the match between the employee and the job situation are not applied. The content of the control condition will vary between different occupational health service units. |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The employee suffers from stress related symptoms or work-related common mental disorders.
- The employee is either not on sick leave or is on sick leave for a maximum of 3 consecutive months (full or part time).
- The employee understands both written and spoken Swedish.
- The employees nearest supervisor should be aware of the employees visit(s) at the OHS (to avoid differential selection into the experimental and the control condition)
Key exclusion criteria (5 listed)
- Bullying
- Pregnancy
- Post traumatic stress-disorder
- Severe mental disorders (e.g. psychosis)
- Any co-morbidity that may substantially affect the employee's ability to work and/or quality of life.
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 based interventionThe intervention comprises both the employee and the employer, and follows a clear structure comprising problem solving, stepwise activation and relapse prevention. It includes three meetings at the OHS with additional follow-ups. | Behavioural | Problem-solving based intervention |
| Treatment as usualStudy participants that are randomized into the control group will receive the usual care given at the OHS. This intervention will differ due to differences between the OHS units. | Behavioural | Treatment as usual |
Primary outcome
Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period.
Time frame: At baseline and 12 months after baseline.
(1) Total sick leave in days, register data (sickness benefit and disability pension). Sickness benefit and disability pension will also be analyzed separately. The analyses will be repeated for outcomes on registered sick leave at a three-years follow-up
26 secondary outcomes
Change from baseline in self-reported sickness absenteeism during the 12 months follow-up period
Time frame: At baseline and during monthly follow-ups for a period of 12 months
The prevalence of no sick leave, part-time sick leave and full-time sick leave during the 12 months follow-up period following baseline
Time frame: Twelve months after baseline
Among those sick listed at baseline: Time to full Return to Work (RTW) during a follow-up period of 12 months
Time frame: At baseline and during monthly follow-ups for a period of 12 months
Among those sick listed at baseline: Time to Return to Work (RTW) during a follow-up period of 12 months
Time frame: At baseline and during monthly follow-ups for a period of 12 months
Work performance impairment due to health problems
Time frame: Will be assessed at baseline and once a month during a 12-month follow-up period
Work performance impairment due to problems in working environment
Time frame: Will be assessed at baseline and every other month (eighth weeks intervals) during a 12-month follow-up period
Cost-effectiveness of the intervention compared to treatment as usual.
Time frame: At 12 months after baseline
Work satisfaction
Time frame: Will be assessed at baseline and after 6 and 12 months.
Work ability index (WAI)
Time frame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
Sickness presenteeism
Time frame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
The Institute of Stress Medicine's instrument for self-rating of stress-related Exhaustion Disorder (s-ED)
Time frame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
Maslach Burnout Inventory - General Survey, Exhaustion-scale
Time frame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
Hospital Anxiety and Depression Scale
Time frame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
Self-perceived health
Time frame: Will be assessed at baseline and after 6 and 12-months of study inclusion.
European Quality of Life - 5 Dimensions questionnaire (EQ-5D)
Time frame: Will be measured at baseline and after 6 and 12-months of study inclusion.
Self-reported stress
Time frame: At baseline and every other month (eighth weeks intervals) during a follow-up period of 12 months
Karolinska Sleep Questionnaire, Insomnia sub-scale
Time frame: Will be measured at baseline and after 6 and 12-months of study inclusion.
Demand-control-support model. Prognostic variable.
Time frame: Baseline and at 6 and 12 months of study inclusion
Other work related variables such as ongoing conflicts with the superior, perceived loss of control over work tasks and conflicts between the employee´s values and how the work actually is done. Prognostic variables.
Time frame: Baseline and at 6 months after study inclusion
Physical activity. Prognostic variable.
Time frame: At 6 and 12 months after intervention
Change in work conditions. Prognostic variable.
Time frame: At 6 and 12 months after intervention
Change in the organization. Prognostic variable.
Time frame: At 6 and 12 months after intervention
Participants' satisfaction and experiences with the intervention or treatment as usual will be assessed at 6 months after completed intervention by eleven items (response format from 0-10 or yes/no/do not know). Process evaluation data.
Time frame: Will be assessed 6 months after intervention.
OHS staff's adherence to the intervention (process evaluation data)
Time frame: Assessed at the end of the 12-18 months long recruitment period
Implementation of the intervention and entire research project at the OHS units (process evaluation data)
Time frame: Assessed at the end of the 12-18 months long recruitment period
Three years follow-up: Change from Baseline in registered sickness absenteeism during a 3-year follow-up period
Time frame: At baseline and 3 years after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Background: PubMed 28494753Bergstrom G, Lohela-Karlsson M, Kwak L, Bodin L, Jensen I, Torgen M, Nybergh L. Preventing sickness absenteeism among employees with common mental disorders or stress-related symptoms at work: Design of a cluster randomized controlled trial of a problem-solving based intervention versus care-as-usual conducted at the Occupational Health Services. BMC Public Health. 2017 May 12;17(1):436. doi: 10.1186/s12889-017-4329-1.
- Background: PubMed 32291291Keus van de Poll M, Nybergh L, Lornudd C, Hagberg J, Bodin L, Kwak L, Jensen I, Lohela-Karlsson M, Torgen M, Bergstrom G. Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services. Occup Environ Med. 2020 Jul;77(7):454-461. doi: 10.1136/oemed-2019-106353. Epub 2020 Apr 14.
- Background: PubMed 32698470Keus Van De Poll M, Bergstrom G, Jensen I, Nybergh L, Kwak L, Lornudd C, Lohela-Karlsson M. Cost-Effectiveness of a Problem-Solving Intervention Aimed to Prevent Sickness Absence among Employees with Common Mental Disorders or Occupational Stress. Int J Environ Res Public Health. 2020 Jul 20;17(14):5234. doi: 10.3390/ijerph17145234.
- Derived from this study: PubMed 38907784Toropova A, Bjork Bramberg E, Bergstrom G. Return to Work Trajectories of Swedish Employees on Sick-Leave Due to Common Mental Disorders. J Occup Rehabil. 2025 Sep;35(3):479-490. doi: 10.1007/s10926-024-10216-9. Epub 2024 Jun 22.
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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.
Gunnar Bergström, 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 based intervention and Treatment as usual in people with Common Mental Disorders and/or Stress Related Symptoms, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in total registered sickness absenteeism during the 12 month follow-up period. (time frame: At baseline and 12 months after baseline.). 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 NCT02563743, which also lists 4 linked publications.
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 13 Sep 2021.