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DepressionPROSANCT03346395

A Problem Solving Based Intervention for Facilitating Return-to-work Among People Suffering From Common Mental Disorders

A study testing Problem solving based intervention and Care as usual in people with Depression and Anxiety Disorders, run by Karolinska Institutet at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Problem solving based intervention involving the workplace has shown promising effects on return-to-work among persons with common mental disorders. A key element is cooperation between the person on sick leave, the participant's employer and health care professionals. Read more about this study

Who is it for?
Ages 18 to 59 years
What is being tested?
Problem solving based intervention and Care as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
2 sitesSweden
Study dates
11 Jan 2018to 17 Jan 2023
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

  • employed women and men aged 18-59, short-term sick leave (i.e. a minimum of 2 weeks and a maximum of 12 weeks) due to mild to moderate depression, anxiety or adjustment disorder (F 32, F 41, F 43) as the primary reason for sick leave, diagnosed by a general practitioner (GP) or physician according to the Swedish version of international statistical classification of diseases and related health problems - tenth revision (ICD-10) contact with a GP or physician at a primary health care center in the vestra gotaland region.

Who cannot join

  • Severe depression, other severe mental disorders, i.e. psychotic or bipolar disorders; pregnancy, somatic complaints or disorders that will influence work ability; not able to read, write and understand Swedish.

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites
  • Primary health care

    Gothenburg, Region Västra Götaland, 40530

  • Elisabeth Björk Brämberg

    Gothenburg, Västra Götaland County, 40530

Other trials in Sweden

About this study

Official title: A Problem Solving Based Intervention in Primary Health Care for Facilitating Return-to-work Among People Suffering From Common Mental Disorders - a Cluster-randomized Trial

Problem solving based intervention involving the workplace has shown promising effects on return-to-work among persons with common mental disorders. A key element is cooperation between the person on sick leave, the participant's employer and health care professionals. The aim of the present study is to evaluate the effects of a problem solving based intervention in the Swedish primary health care system on an employed population on sick leave due to common mental disorders. Cluster randomized controlled trial. The investigators hypothesize that:

Participants who have undergone the work-related problem solving based intervention will have fewer total days on sick leave than the participants who receive treatment as usual at 18 months.

Read more

Participants who receive the work-related problem solving based intervention will have fewer recurrent periods of sick leave than the participants who receive treatment as usual at 18 months.

Participants who receive the work-related problem solving therapy intervention will score better on the secondary outcomes than the participants in the control group.

Population: Employed, aged 18 - 59, on short-term sick leave (min. 2 - max. 12 weeks) due to common mental disorders.

Intervention: Work-related problem solving based intervention in addition to treatment as usual. The intervention will be given by rehabilitation coordinators on max. five occasions and includes: making an inventory of problems and/or opportunities related to return-to-work; identifying the support needed to implement the solutions; a meeting with the person on sick leave, his/her employer and the rehabilitation coordinator to discuss solutions; making an action plan and evaluation.

Control: The control group will receive care as usual (i.e. cognitive behavioral therapy and/or medical treatment, and meeting with a rehabilitation coordinator if this is a part of care as usual at the primary health care centre). A total of 220 persons on sick leave and 30 rehabilitation coordinators will be included.

Primary outcome: total number of days on sick leave at 18 months after baseline. A parallel process evaluation will be conducted to examine: to what extent it is possible to implement problem-solving therapy according to the protocol; the relationship between the key elements of problem-solving intervention and the effect outcome; how the participants perceive the intervention.

Being tested
Problem solving based intervention, Care as usual
Keywords
Adjustment disorders, Anxiety disorders, Depression, Mental disorders, Interventional study, Primary health care, Problem solving, Randomized controlled trial, Return to work, Sick leave
Medical subject headings
Depression, Anxiety Disorders, Adjustment Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Problem solving based interventionBehavioural

    Problem solving based intervention

  • Care as usualBehavioural

    Medical treatment, or behavioral therapy or a coordination of behavioral therapy and medical treatment. Meeting with a rehabilitation coordinator.

Study groups in NCT03346395
Study groupRoleWhat they receive
Problem solving based interventionExperimentalThe problem solving based intervention contains a problem solving process and cooperation between the person on sick leave, his/her employer and health care professionals. The intervention consists of five steps: 1) Making an inventory of problems and/or opportunities related to return to work; 2) brainstorming about solutions; 3) writing down solutions, identifying the support needed to implement the solutions; 4) a three-party meeting with the person on sick leave, his/her employer and the rehabilitation coordinator; 5) evaluation of the action plan and implementation of solutions, relapse prevention. The intervention takes the form of two to five consultations. The first and fourth steps are key elements.
Receives: Behavioral: Problem solving based intervention
Care as usualActive comparatorMedical treatment, or behavioral therapy or in combination. Meeting with a rehabilitation coordinator if that is a part or care as usual within primary health care.
Receives: Behavioral: Care as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in total registered sickness absenteeism in number of days from baseline during the 18 month follow-up.

    Change in total registered sickness absenteeism in number of days from baseline during the 18 months follow-up (including sickness benefit, sickness and activity compensation, disability pension). Data from the Social Insurance Agency's register MiDAS.

    The analyses will be repeated for outcomes on registered sickness absence at a three-year follow-up.

    Measured: At baseline and 18 months after baseline.

Secondary outcomes (25)
  1. Change from baseline in registered part-time sickness absenteeism during the 18 months follow-up

    Change from baseline in registered partial sickness absenteeism (25/50/75% of full-time sickness absenteeism) during a follow-up period of 18 months. Change in registered sickness absenteeism will be calculated from baseline until the 18 months follow-up in number of days on part-time sick leave (25/50/75% of full-time sick leave). Data from the Social Insurance Agency's register MiDAS.

    Measured: From baseline to 18 months after baseline.

  2. Change from baseline in return to work during a period of 18 months.

    Change from baseline in return to work during a follow-up of 18 months. Return to work will be calculated from baseline data until the individual returns to work in ordinary hours during an uninterrupted period of at least four weeks.

    Measured: From baseline to 18 months after baseline.

  3. Episodes of sickness absenteeism after full-time return to work

    Episodes of sick leave after full-time return to work (i.e. work in ordinary hours during an uninterrupted period of at least four weeks) will be calculated from baseline until the 18 months follow-up by registered sickness absenteeism.

    Measured: From baseline during 18 months follow-up.

  4. Change in total registered sick leave from baseline to 36 month follow-up.

    Change in total registered sickness absenteeism at baseline and during the 36 months follow-up (including sickness benefit, sickness and activity compensation, disability pension). Data from the Social Insurance Agency's register MiDAS.

    Measured: Change in total registered sick leave from baseline to 36 month follow-up.

  5. Possible interaction effects

    Possible interaction effects on the primary and secondary outcomes for (1) gender x treatment, and (2) number of sessions with rehabilitation coordinator x treatment will be checked for and if statistically significant subgroup analyses will be considered.

    Measured: Change from baseline and 6, 12 and 18 months after study inclusion.

  6. Self-reported short-term sickness absenteeism

    Change in self-reported sickness absenteeism from baseline during the 12 month follow-up. Self-reported data collected every fourth week during the 12 months. These self-reported data cover shorter spells of sickness absenteeism (i.e. ≤14 consecutive days) that is not covered by the Social Insurance Agency's register.

    Measured: From baseline to 12 months after baseline.

  7. Change from baseline in self-reported part-time sickness absenteeism during the 12 months follow-up

    Change from baseline in self-reported partial sickness absenteeism (25/50/75% of full-time sickness absenteeism) during a follow-up period of 12 months. Change in self-reported sickness absenteeism will be calculated from baseline until the 12 months follow-up in number of days on part-time sick leave (25/50/75% of full-time sick leave).

    Measured: From baseline to 12 months after baseline.

  8. Change from baseline in return to work during a period of 12 months.

    Change from baseline in self-reported return to work during a follow-up of 12 months. Return to work will be calculated from baseline data until the individual returns to work in ordinary hours during an uninterrupted period of at least four weeks. Self-reported data obtained every fourth week during a period of 12 months.

    Measured: From baseline to 12 months after baseline.

  9. Episodes of self-reported sickness absenteeism after full-time return to work.

    Episodes of self-reported sickness absenteeism after full-time return to work (i.e. work in ordinary hours during an uninterrupted period of at least four weeks) will be calculated from baseline until the 12 months follow-up by self-reported sickness absenteeism.

    Measured: From baseline during 12 months follow-up.

  10. Reduction of symptoms related to common mental disorders Hospital Anxiety and Depression scale

    Hospital Anxiety and Depression Scale will be used to assess symptoms of anxiety (seven items) and depression (seven items). Each item is scored on a 4-point Likert scale indicating the extent to which an item was experienced in the past week. Response format from 0 to 3.

    Measured: Baseline and 6 and 12 months after study inclusion.

  11. Reduction of symptoms related to common mental disorders Self-reported exhaustion

    Institute of Stress Medicine's instrument for self-reported exhaustion: Change from baseline in self-reported exhaustion as measured by the Institute of Stress Medicine's instrument. Three items with the response format yes/no and one item with response format from 0 to 2.

    Measured: Baseline and 6 and 12 months after study inclusion.

  12. Reduction of symptoms related to common mental disorders Karolinska Sleep Questionnaire

    Karolinska Sleep Questionnaire, Insomnia subscale will be used for assessing insomnia problems. The subscale includes four items. Each item is scored on a 6 point scale ranging from 0 (never) to 5 (always) indicating to what extent an item was experienced in the last three months. Change from baseline in self-reported sleep problems.

    Measured: Baseline and 6 and 12 months after study inclusion.

  13. Sickness presenteeism

    Sickness presenteeism will be measured with a single question, response format 1-4.

    Measured: Baseline and after 6 and 12 months after study inclusion.

  14. Work ability index (WAI)

    WAI: change from baseline and after 6 and 12 months after study inclusion, self-reported work ability is assessed by 2 items from WAI (with the response format 1 - 5). These questions measures the perceived work capacity in relation to the physical (1 item) and the mental (1 item) demands of the work.

    Measured: Baseline and 6 and 12 months after study inclusion.

  15. Work performance impairment due to health problems

    Work performance due to health problems will be measured by a question from one of the items included in the Work Productivity Impairment - General Health Questionnaire (the response format is 0-10).

    Measured: Will be assessed at baseline and once a month during a 12-month follow-up period.

  16. Work performance impairment due to problems in the working environment

    Work performance due to problems in the working environment will be measured by a question from one of the items included in the Work Productivity Impairment - General Health Questionnaire (the response format is 0-10).

    Measured: Will be assessed at baseline and once a month during a 12-month follow-up period.

  17. Demand-control-support

    Demand-control-support model: Change from baseline and after 6 and 12 months after study inclusion, response format from 1 to 4. Prognostic variable.

    Measured: Baseline and after 6 and 12 months after study inclusion.

  18. Return-to-work self-efficacy

    Return-to-work self-efficacy will be measured by a question with the response format from 0 to 10. Prognostic variable.

    Measured: Change from baseline and 6 and 12 months after study inclusion.

  19. Ongoing conflict with the superior

    Ongoing conflict with the superior is measured by one item. The item is scored on a 3 point Likert-type scale ranging from 0 (never) to 3 (often or always). Prognostic variable.

    Measured: Change from baseline at 6 and 12 months after study inclusion.

  20. Perceived loss of control over work tasks

    Perceived loss of control over work tasks is measured by one item. The item is scored on a Likert-type scales with 5 response options ranging from 0 (never or almost never) to 4 (very often or always). Prognostic variable.

    Measured: Change from baseline at 6 and 12 months after study inclusion.

  21. Conflict between employee's values and how the work actually is done

    Conflict between employee's values and how the work actually is done is measured by three items. Each item is scored on a Likert-type scale5 response options ranging from 0 (never or almost never) to 4 (very often or always). Prognostic variable.

    Measured: Change from baseline at 6 and 12 months after study inclusion.

  22. Job strain

    Job strain (emotional and psychological demands) will be assessed by four items from Copenhagen psychosocial questionnaire, response format is likert-type scales with 5 response options. Prognostic variable.

    Measured: Change from baseline at 6 and 12 months after study inclusion.

  23. Participants' satisfaction

    Participants' satisfaction and experiences with their participation in the intervention or care as usual will be assessed at 6 months after completed intervention, as a part of the process evaluation. Self-reported questionnaire with ten items, response format from 0 to 10 or yes/no/do not know.

    Measured: Will be assessed at 6 months after intervention.

  24. The rehabilitation coordinators' adherence to the intervention.

    The rehabilitation coordinators' adherence to the intervention is measured by a single item with the response format from 1 to 5.

    Measured: Assessed immediately upon completion of intervention.

  25. Health related quality of life

    Health related quality of life will be measured with European Quality of Life 5 Dimensions questionnaire (EQ5D). The response format is a 3-level scale, with higher levels indicating severity.

    Measured: Will be measured at baseline, 6 and 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start11 Jan 2018
  3. Primary completion31 Dec 2022
  4. Study completion17 Jan 2023

Resources

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
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03346395
Sponsor's protocol ID
2016-07415
Other IDs
2016
Acronym
PROSA
Status last verified
Jan 2023
First submitted
11 Oct 2017
Last updated
18 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: There is a plan to make IPD and related data available. In line with the study's ethical approval, data may only be made available after reasonable request to the principal investigator, and after decision by the Swedish Ethical Review Authority.

Publications

  • Karlsson I, Kwak L, Bultmann U, Bergstrom G, Axen I, Bjork Bramberg E. Process Evaluation of a Problem-Solving Intervention with Workplace Involvement for Employees on Sickness Absence Due to Common Mental Disorders in Swedish Primary Health Care. J Occup Rehabil. 2026 Aug 1. doi: 10.1007/s10926-026-10441-4. Online ahead of print.

    PubMed 42541653
  • Eklund A, Karlsson I, Bergstrom G, Lisa H, Elisabeth BB. The effectiveness of a problem-solving intervention with workplace involvement on self-reported sick leave, psychological symptoms and work ability: a cluster randomised clinical trial. BMC Public Health. 2024 Nov 5;24(1):3052. doi: 10.1186/s12889-024-20564-z.

    PubMed 39501245
  • Karlsson I, Frantz A, Axen I, Bergstrom G, Bultmann U, Finnes A, Holmgren K, Kwak L, Bjork Bramberg E. Is a Problem-Solving Intervention with Workplace Involvement for Employees on Sickness Absence Due to Common Mental Disorders More Effective, than Care as Usual, in Reducing Sickness Absence Days? Results of a Cluster-Randomised Controlled Trial in Primary Health Care. J Occup Rehabil. 2025 Sep;35(3):615-624. doi: 10.1007/s10926-024-10229-4. Epub 2024 Aug 7.

    PubMed 39110387
  • Toropova 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
  • Holmlund L, Ljungberg HT, Bultmann U, Bramberg EB. Navigating work and life- a qualitative exploration of managers' and employees' views of return-to-work after sick leave due to common mental disorders. BMC Public Health. 2024 Feb 5;24(1):372. doi: 10.1186/s12889-024-17765-x.

    PubMed 38317150
  • Bjork Bramberg E, Holmgren K, Bultmann U, Gyllensten H, Hagberg J, Sandman L, Bergstrom G. Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA). BMC Public Health. 2018 Jul 18;18(1):889. doi: 10.1186/s12889-018-5816-8.

    PubMed 30021545

Questions about this trial

What is this clinical trial studying?

A study testing Problem solving based intervention and Care as usual in people with Depression and Anxiety Disorders, run by Karolinska Institutet at 2 sites 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 1 inclusion and 1 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 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 in total registered sickness absenteeism in number of days from baseline during the 18 month follow-up. (time frame: At baseline and 18 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 NCT03346395, which also lists 6 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 18 Jan 2023.

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