ClinicalTrials.gg
CompletedNCT03022760PRIMAUpdated Jun 12, 2020

Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care

An interventional study of Work-related measures in Stress, Psychological, Burnout, Professional and Adjustment Disorders, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-12.

Primary conditionBurnout, ProfessionalRegistry: Stress, PsychologicalReclassifiedWhy we changed it
Registry
Stress, Psychological — the first condition term the registry derived for this study.
ClinicalTrials.gg
Burnout, Professional
Why
  1. The study's listed conditions name Burnout, Professional, a narrower term within Stress, Psychological.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this project is to develop a model for return to work (RTW) for patients sick listed due to stress related mental disorders, which takes into account each patient's specific situation; includes the workplace, and is well adapted to the Swedish primary care setting.

In late 2016, general practitioners (GPs) and rehabilitation coordinators at both public and private primary care centers will be offered a one-day training about work and workability for patients with stress related mental disorders. Also, the participants will be trained in a specific method that includes the patient's employer early in the rehabilitation process

The project has a quasi-experimental and longitudinal design. The intervention will be conducted on 15 different primary care centers, which will be matched with a comparison group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18 months after sick-listing. The hypothesis is that patients who are sick-listed at primary care centers that completely or partially implemented the specific method on average will return earlier to work than patients sick-listed at primary care centers that did not implement the method.

Alongside studying if the intervention has an effect on the patients' RTW over time, the investigators aim to investigate the mechanisms explaining the effects and the individual and organizational level (primary care units) circumstances necessary for these mechanisms to be triggered. To gain deeper knowledge about mechanisms and context, the investigators will conduct interviews with the treatment staff and collect registry data about the primary care units.

02

Conditions studied

  • Stress, Psychological
  • Burnout, Professional
  • Adjustment Disorders

Browse trials for

Keywords

  • Exhaustion Disorder
03

In context

Burnout, Professional Reclassified

216 studies on the registry are indexed under Burnout, Professional; 33 are open to participants now.

This study's enrollment of 132 is above the median of 80 across 161 interventional studies indexed under Burnout, Professional.

Browse Burnout, Professional studies →

Lead sponsor

Vastra Gotaland Region is the lead sponsor of 275 studies on the registry; 109 are open to participants now.

Compared within Burnout, Professional, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stress, Psychological. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of International Classification of Diseases (ICD)10 F43
  • Has an employment
  • Good command in spoken and written Swedish

Exclusion criteria

Exclusion Criteria:

  • Participants must not have been on long term sick-leave (>60 days) during the last three years, regardless of causative diagnosis.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (actual)

Study arms

  • Active comparator
    Work-related measures

    * One-day training for GP:s and rehabilitation coordinators * A treatment protocol which includes contact with the patient's employer * Clinical support from the Institute of Stress Medicine

    Behavioral: Work-related measures

  • No intervention
    Treatment as usual

Interventions

  • BehavioralWork-related measures

    After mapping the patient's psychosocial work situation using tools provided at the one-day training, the patient's employer will be contacted and involved in the rehabilitation planning.

06

What researchers measure

Primary outcomes

  1. Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.

    Time frame: Three measurement time points. First measurement will occur 6 months from baseline.

  2. Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.

    Time frame: Second measurement time point will occur at 12 months from baseline.

  3. Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.

    Time frame: Third measurement time point will occur at 18 months from baseline.

07

Study locations

1 site
  • Gothenburg, Sweden
08

References and documents

Publications

  • Bjork L, Glise K, Pousette A, Bertilsson M, Holmgren K. Involving the employer to enhance return to work among patients with stress-related mental disorders - study protocol of a cluster randomized controlled trial in Swedish primary health care. BMC Public Health. 2018 Jul 6;18(1):838. doi: 10.1186/s12889-018-5714-0. PubMed 29976181 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2016 to primary completion in Jan 2019, 25 months.

Of 128 non-industry interventional studies with no phase under Burnout, Professional, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's 25 months is above that.

Counting every sponsor, half of 132 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2016
First posted
Jan 16, 2017
StartActual
Dec 2016
Primary completionActual
Jan 2019
CompletionActual
May 2020
Last update
Jun 12, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03022760
Responsible party
Sponsor
First posted
Jan 16, 2017
Start date
Dec 2016
Primary completion
Jan 2019
Completion
May 2020
Last update
Jun 12, 2020

Study contacts

Lisa Björk
study director · the Institute of Stress Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion