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Depressive DisorderCO-WORK-CARENCT03250026

Cooperation for Primary Care Patients on Sick Leave for CMD: Care Manager and Workplace Intervention - CO-WORK-CARE

A study testing Workplace convergence dialogue and Care Manager in people with Depressive Disorder and Anxiety Disorders, run by Göteborg University at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the Primary Care Centre Rehab Coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with a Care Manager during the period of sick… Read more about this study

Who is it for?
Ages 18 to 67 years
Conditions the study is for
Depressive Disorder, Anxiety Disorders
What is being tested?
Workplace convergence dialogue and Care Manager
Could I receive a placebo?
No, everyone receives an active treatment
How many people
349 participants
Where
1 siteSweden
Study dates
5 Dec 2017to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 67 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients attending primary care centers with care manager function
  • aged >=18 to 67 years
  • diagnosed with a new (< 1 month) depression diagnose (F32, F33), anxiety syndrome (F41, F48) or stress related adjustment disorder (F43)
  • on sick-leave > 14 days

Who cannot join

  • Bipolar disorder
  • psychosis
  • addiction
  • other serious mental disorder
  • suicidal ideation or earlier suicide attempt
  • cognitive impairment or not speaking/understanding Swedish

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Primary Health Care, Sahlgrenska Academy

    Gothenburg, Region Västra Götaland, 40530

Other trials in Sweden

About this study

Official title: Cooperation for Patients With Common Mental Disorders: Care Manager Function at the Primary Care Centre and Intervention at the Workplace - CO-WORK-CARE

This study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the Primary Care Centre Rehab Coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with a Care Manager during the period of sick leave. The study will be performed as a randomised controlled trial with randomisation at the PCC level where intervention PCCs offers a convergence dialogue meeting with the work place representative during sick leave in addition to Care Manager contact.

Read the detailed description

In Sweden sick leave time and frequency are increasing. This is primarily in the area of common mental disorders (CMD), and CMD is now the most common single cause of sickness absence. Primary care is the area in which most individuals with mental illness seek care and also receive care. A Care Manager function at the primary care centre (PCC) where the Care Manager is responsible for the support and close contact with patients with CMD and act as the "spider in the web" and combine patient support with other measures, have been shown to have beneficial effects for depression course. In Region Västra Götaland an implementation of the Care Manager function at the PCC has been set out, and the function is now available in nearly 100 PCCs in the region. The present study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the PCCs Rehab Coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with the Care Manager during the period of sick leave. The study will be performed as pragmatic randomised controlled trial with randomisation at the PCC level. Around 20 PCCs with a Care Manager function for patients on sick-leave with CMD diagnosis will be recruited and randomized to intervention where patients in addition to a Care Manager contact (12 weeks) will have one convergence dialogue meeting with the work place representative during sick leave. Control PCCs will give Care Manager contact 12 weeks only.

Being tested
Workplace convergence dialogue, Care Manager
Keywords
primary care, convergence dialogue, sick leave, care manager
Medical subject headings
Depressive Disorder, Anxiety Disorders

What participants receive

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

  • Workplace convergence dialogueBehavioural

    Work place contact as a convergence dialogue between the employer and employee with the Rehab Coordinator as a guide

  • Care ManagerBehavioural

    Regular contact Care Manager during around 12 weeks

Study groups in NCT03250026
Study groupRoleWhat they receive
Intervention (Workplace dialogue)ExperimentalIntervention: Work place convergence dialogue contact
Receives: Behavioral: Workplace convergence dialogue; Behavioral: Care Manager
Care ManagerActive comparatorIntervention: Care Manager contact 12 weeks (Care as usual)
Receives: Behavioral: Care Manager

What is being measured

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

  1. Net and gross sick-leave days

    number of net and gross sick-leave days during 12 months

    Measured: 12 months

Secondary outcomes (5)

  1. Depressive symptoms

    Change of depressive symptoms Montgomery-Asberg Depression Rating Scale - Self rating version (MADRS-S) Range 0-60 (Total score) Low score better outcome

    Measured: 6 and 12 months

  2. Anxiety symptoms

    Change of anxiety symptoms Generalized Anxiety Disorder 7-item (GAD-7) scale Range 0-15 (total score) low score better outcome

    Measured: 6 and 12 months

  3. Quality-of-life questionnaire score

    Change of quality of life EuroQoL-5 Dimension Questionnaire(EQ-5D) Range 0-1.0(total score) low score worst outcome

    Measured: 6 and 12 months

  4. Work ability

    Change of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome

    Measured: 6 and 12 months

  5. Exhaustion

    Change of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome

    Measured: 6 and 12 months

Timeline

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

  1. First posted15 Aug 2017
  2. Study start5 Dec 2017
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
Model description
Pragmatic randomised controlled trial; randomisation on primary care centre level
Masking
None (open label)
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03250026
Sponsor's protocol ID
459-17
Acronym
CO-WORK-CARE
Status last verified
Apr 2025
First submitted
9 Aug 2017
Last updated
11 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data of individual participants will be made available to other researchers, provided reasonable request by personal contact, as soon as publication of results is effected.

Publications

  • Petersson EL, Tornbom K, Hange D, Nejati S, Jerlock M, Wikberg C, Bjorkelund C, Svenningsson I. The experiences of care managers and rehabilitation coordinators of a primary care intervention to promote return to work for patients with common mental disorders: a qualitative study. BMC Fam Pract. 2020 Dec 18;21(1):272. doi: 10.1186/s12875-020-01348-x.

    PubMed 33339512

  • Petersson EL, Tornbom K, Bjorkelund C, Jerlock M, Hange D, Udo C, Svenningsson I. Process evaluation of the CO-WORK-CARE model: Collaboration and a person-centred dialogue meeting for patients with common mental disorder in primary health care. Scand J Caring Sci. 2024 Sep;38(3):602-613. doi: 10.1111/scs.13268. Epub 2024 May 8.

    PubMed 38718100

  • Saxvik A, Svenningsson I, Tornbom K, Petersson EL, Bjorkelund C, Gabartaite G, Hange D. GPs' experiences of a collaborative care model for patients with common mental disorders who need sick leave certification: a qualitative study. BJGP Open. 2022 Dec 20;6(4):BJGPO.2022.0042. doi: 10.3399/BJGPO.2022.0042. Print 2022 Dec.

    PubMed 35977733

  • Saxvik A, Tornbom K, Petersson EL, Hange D, Nejati S, Bjorkelund C, Svenningsson I. Experiences of patients with common mental disorders concerning team-based primary care and a person-centered dialogue meeting: An intervention to promote return to work. PLoS One. 2022 Jul 8;17(7):e0271180. doi: 10.1371/journal.pone.0271180. eCollection 2022.

    PubMed 35802679

  • Bjorkelund C, Petersson EL, Svenningsson I, Saxvik A, Wiegner L, Hensing G, Jonsdottir IH, Larsson M, Wikberg C, Ariai N, Nejati S, Hange D. Effects of adding early cooperation and a work-place dialogue meeting to primary care management for sick-listed patients with stress-related disorders: CO-WORK-CARE-Stress - a pragmatic cluster randomised controlled trial. Scand J Prim Health Care. 2024 Sep;42(3):378-392. doi: 10.1080/02813432.2024.2329212. Epub 2024 Mar 31.

    PubMed 38555865

  • Bjorkelund C, Saxvik A, Svenningsson I, Petersson EL, Wiegner L, Larsson M, Tornbom K, Wikberg C, Ariai N, Nejati S, Hensing G, Hange D. Rehabilitation cooperation and person-centred dialogue meeting for patients sick-listed for common mental disorders: 12 months follow-up of sick leave days, symptoms of depression, anxiety, stress and work ability - a pragmatic cluster randomised controlled trial from the CO-WORK-CARE project. BMJ Open. 2023 Jun 9;13(6):e074137. doi: 10.1136/bmjopen-2023-074137.

    PubMed 37295824

  • Svenningsson I, Bjorkelund C, Hange D, Wiegner L, Ariai N, Petersson EL. Symptom patterns in patients newly sick listed for common mental disorders and associations with work-related and socioeconomic factors: a cross-sectional study in Swedish primary care. BMJ Open. 2022 Jul 8;12(7):e054250. doi: 10.1136/bmjopen-2021-054250.

    PubMed 35803640

Questions about this trial

What is this clinical trial studying?

A study testing Workplace convergence dialogue and Care Manager in people with Depressive Disorder and Anxiety Disorders, run by Göteborg University 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 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Apr 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Net and gross sick-leave days (time frame: 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 NCT03250026, which also lists 7 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 11 Apr 2025.

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