Sick LeaveNCT05772494
Assessment of Activity Limitations, a Basis for Understanding the Need for Sickness Certificate and Rehabilitation
A study testing Assessment of activity limitations, SDO and DOA in people with Sick Leave, run by Göteborg University at 1 site in Sweden.
Trial summary
In Sweden mental disorders have the highest proportion of sickness absence and sickness spells. One cause for this is proposed as the lack of knowledge on which activity limitations that have an impact on the ability to return to work. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sick Leave
- What is being tested?
- Assessment of activity limitations, SDO and DOA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 3 Apr 2023to Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients registered at the chosen psychiatric care centers, in need for their second or third sickness certificate within the unit.
Who cannot join
- Patients with specific diagnosis belonging to another unit within the psychiatric organization.
- Patients assessed as being in an acute vulnerable situation where the planned intervention could negatively influence the situation e.g. having suicidal thoughts, or having such language difficulties that an interpreter is needed (which could complicate the understanding of the meaning of the intervention and cause unnecessary worries).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Göteborg University, Institute of Neuroscience and Physiology
Gothenburg, 40530
About this study
Official title: Early Assessment of Activity Limitations, a Basis for Understanding the Need for Sickness Certificate and Rehabilitation. A Randomized Controlled Study of People With Mental Disorders in Specialized Psychiatric Care
In Sweden mental disorders have the highest proportion of sickness absence and sickness spells. One cause for this is proposed as the lack of knowledge on which activity limitations that have an impact on the ability to return to work. Further, there is a knowledge gap concerning the effect of which early measures from the health system, assessments and early rehabilitation interventions, that enables return to work. Such early measures have been proposed to have a more multidimensional perspective, than to solely focus on specific tasks during a work situation.
The aim of the current project is to examine the effect of an early assessment of activity limitations, made by occupational therapists within specialized psychiatric care, at the time for the next prolonged sickness certification. The assessment will be included in the sickness certificate, and results will be compared between the intervention group and a control group. The results are calculated for differences on treatment measures, prevalence of questions from the Social Insurance Agency and changes in the patterns for sick leave spells. Further, the prevalence of activity limitations and the sick listed participants assessments of the effect of the intervention will be presented.
The results are expected to lead to more adequate interventions for the individual regarding support to return to work, better routines for assessment and rehabilitation within the health care system, which in turn can facilitate decisions for sickness benefits and further have an impact on the long sick leave spells concerning mental disorders.
Read the detailed description
Several individuals diagnosed with mental health disorders get sick-listed, and further, stay within the sick-leave process for a prolonged period. More research has been warranted both concerning how to assess activity limitations and future work capacity when having a psychiatric diagnose, but also when it comes to find suitable measures for supporting individuals to return to work. Such supportive and rehabilitative measures could be situated within the healthcare system, such as specialized psychiatric care. To conduct these measures, both early assessments as well as investigation of the effect of taken measures are needed. The present study concerns an expanded assessment of activity limitations as a basis for possible interventions with a focus on the individuals sick-leave process.
The understanding of work capacity has been proposed as a complex phenomenon, where several perspectives are needed. The contribution from occupational therapist in the teamwork implies being focussed on activity limitations or facilitators in contrast to solely focussing on body functions or symptoms. In the professional vocabular, activities are named occupations, meaning that the actual performance is influenced both by individual experiences and influenced by factors in the environment. Another assumption is that all everyday life occupations are interacting, and thus could have an impact on work capacity.
The purpose with this randomized, controlled trial is to evaluate if an early and expanded assessment made by occupational therapist, and with the use of two validated instruments A Dialogue About Ability Related to Work (DOA) and Satisfaction with Daily Occupations (SDO), can have an impact on choice of interventions, changes in the patterns for sick leave spells as well as prevalence of questions from the Social Insurance Agency (SIA) and the participators evaluation of effects from being part of the project. The chosen instruments are described as complementing each other, where DOA examines an overall summary of prerequisites for work capacity, and SDO adds a broader understanding of a person's occupations in everyday life, including satisfaction and balance between different occupational arenas such as work, un-paid work, leisure etc.
The project will be carried out in specialized, psychiatric teams within the Region Västra Götaland. The aim is to recruit 150 participants (75 to the intervention group and 75 to the control group). The participants will be randomly and consecutively divided into intervention or control group. Inclusion criteria are all patients registered at the chosen psychiatric care centres, in need for their second sickness certificate within the unit. Exclusion criteria are patients with specific diagnosis belonging to another unit within the psychiatric organization, and if the patient is assessed as being in an acute vulnerable situation where the planned intervention could negatively influence the situation. Register follow-ups on health care treatment, sick-leave spells, questions from SIA will be made 6 and 12 months later. The participant questionnaire will be sent 6 months after the intervention. Four studies are planned to evaluate the intervention.
The study is a collaborative project involving Region Västra Götaland. The research team comprise researchers from Göteborg University (C Andersson and K Holmgren) and from Region Västra Götaland (C Melin). The study has been submitted to the Regional Ethical Review Board.
- Conditions
- Sick Leave
- Being tested
- Assessment of activity limitations, SDO and DOA, Control group
- Keywords
- Sick leave, Mental disorders, Occupational Therapy, Activity limitations
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of activity limitations, SDO and DOAOther
Also called Satisfaction with Daily Occupations (SDO), A Dialogue About Ability Realted to Work (DOA)
The assessment is made with two instruments (DOA, SDO), and finally the occupational therapist includes the analysis and summary of activity limitations to the sickness certificate. For comparative reasons the participant will answer to a sociodemographic questionnaire focusing on work situation and sick leave
Control groupOther
All assessments concerning activity limitations are made using usual routines, primarily by the sick-listing physician. For comparative reasons the participant will answer to a sociodemographic questionnaire focusing on work situation and sick leave
| Study group | Role | What they receive |
|---|---|---|
| Assessment of activity limitation | Experimental | Assessment and analysis of activity limitation by occupational therapist using 2 registered instruments (SDO and DOA). Receives: Other: Assessment of activity limitations, SDO and DOA |
| Control group: treatment as usual | Active comparator | Assessment of activity limitations according to usual routines Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care treatments
Differences in types of healthcare treatment options between intervention and control group. Comparisons will be made between intervention and control group with regard to registered codes for intervention and codes for professionals responsible for treatment options. Descriptive calculations and comparisons will be made on differences in types of as well as changes in treatment measures within the notified time frame.
Measured: 6 months after inclusion
Changes in sick leave patterns
Differences in number of sick leave periods, full-time or part-time or number of sick leave spells between intervention and control group.
Measured: 6 months after inclusion
Number of questions from the Social Insurance Agency (SIA)
Differences in number of clarifying questions from SIA between intervention and control group.
Measured: 6 months after inclusion
Secondary outcomes (1)
Participants self-assessed effects of being part of the project
Data is gathered by a structured questionnaire covering experiences of treatment, support, and effects on need for sick leave after inclusion. Differences in experiences between intervention and control group will be measured. Questions asked are constructed as multiple choice questions, on an ordinal scale, about being on prolonged sick leave, length of sick leave period, having returned to work or not. Questions are further asked about opinions on the effect of treatment on work ability, support for following steps in vocational rehabilitation and contact with other stakeholders within the work rehabilitation process. These latter questions are answered with a 5-point Likert scale, where 1 is "do not agree" and 5 is "fully agreeing".
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start3 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sick LeaveStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants are consecutively assigned to either intervention or control group depending on the time for the next prolonged sick leave period. Participants in the intervention group are invited to an assessment session with an occupational therapist focusing on limitations and enablers in activities related to pre-requisites for returning to work. Participants in the control group receive assessments for sickness certificate according to ordinary routines.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Christina Andersson, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772494
- Sponsor's protocol ID
- FK 2022/012285
- Status last verified
- May 2026
- First submitted
- 1 Mar 2023
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of Activity Limitations, a Basis for Understanding the Need for Sickness Certificate and Rehabilitation. A Randomized Controlled Study of People With Mental Disorders in Specialized Psychiatric Care
- ClinicalTrials.gov ID
- NCT05772494
- Acronym / sponsor ID
- FK 2022/012285
- Conditions
- Sick Leave
- Keywords
- Sick leave, Mental disorders, Occupational Therapy, Activity limitations
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Mar 2023 (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.
In Sweden mental disorders have the highest proportion of sickness absence and sickness spells. One cause for this is proposed as the lack of knowledge on which activity limitations that have an impact on the ability to return to work. Further, there is a knowledge gap concerning the effect of which early measures from the health system, assessments and early rehabilitation interventions, that enables return to work. Such early measures have been proposed to have a more multidimensional perspective, than to solely focus on specific tasks during a work situation.
The aim of the current project is to examine the effect of an early assessment of activity limitations, made by occupational therapists within specialized psychiatric care, at the time for the next prolonged sickness certification. The assessment will be included in the sickness certificate, and results will be compared between the intervention group and a control group. The results are calculated for differences on treatment measures, prevalence of questions from the Social Insurance Agency and changes in the patterns for sick leave spells. Further, the prevalence of activity limitations and the sick listed participants assessments of the effect of the intervention will be presented.
The results are expected to lead to more adequate interventions for the individual regarding support to return to work, better routines for assessment and rehabilitation within the health care system, which in turn can facilitate decisions for sickness benefits and further have an impact on the long sick leave spells concerning mental disorders.
Detailed description
Several individuals diagnosed with mental health disorders get sick-listed, and further, stay within the sick-leave process for a prolonged period. More research has been warranted both concerning how to assess activity limitations and future work capacity when having a psychiatric diagnose, but also when it comes to find suitable measures for supporting individuals to return to work. Such supportive and rehabilitative measures could be situated within the healthcare system, such as specialized psychiatric care. To conduct these measures, both early assessments as well as investigation of the effect of taken measures are needed. The present study concerns an expanded assessment of activity limitations as a basis for possible interventions with a focus on the individuals sick-leave process.
The understanding of work capacity has been proposed as a complex phenomenon, where several perspectives are needed. The contribution from occupational therapist in the teamwork implies being focussed on activity limitations or facilitators in contrast to solely focussing on body functions or symptoms. In the professional vocabular, activities are named occupations, meaning that the actual performance is influenced both by individual experiences and influenced by factors in the environment. Another assumption is that all everyday life occupations are interacting, and thus could have an impact on work capacity.
The purpose with this randomized, controlled trial is to evaluate if an early and expanded assessment made by occupational therapist, and with the use of two validated instruments A Dialogue About Ability Related to Work (DOA) and Satisfaction with Daily Occupations (SDO), can have an impact on choice of interventions, changes in the patterns for sick leave spells as well as prevalence of questions from the Social Insurance Agency (SIA) and the participators evaluation of effects from being part of the project. The chosen instruments are described as complementing each other, where DOA examines an overall summary of prerequisites for work capacity, and SDO adds a broader understanding of a person's occupations in everyday life, including satisfaction and balance between different occupational arenas such as work, un-paid work, leisure etc.
The project will be carried out in specialized, psychiatric teams within the Region Västra Götaland. The aim is to recruit 150 participants (75 to the intervention group and 75 to the control group). The participants will be randomly and consecutively divided into intervention or control group. Inclusion criteria are all patients registered at the chosen psychiatric care centres, in need for their second sickness certificate within the unit. Exclusion criteria are patients with specific diagnosis belonging to another unit within the psychiatric organization, and if the patient is assessed as being in an acute vulnerable situation where the planned intervention could negatively influence the situation. Register follow-ups on health care treatment, sick-leave spells, questions from SIA will be made 6 and 12 months later. The participant questionnaire will be sent 6 months after the intervention. Four studies are planned to evaluate the intervention.
The study is a collaborative project involving Region Västra Götaland. The research team comprise researchers from Göteborg University (C Andersson and K Holmgren) and from Region Västra Götaland (C Melin). The study has been submitted to the Regional Ethical Review Board.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants are consecutively assigned to either intervention or control group depending on the time for the next prolonged sick leave period. Participants in the intervention group are invited to an assessment session with an occupational therapist focusing on limitations and enablers in activities related to pre-requisites for returning to work. Participants in the control group receive assessments for sickness certificate according to ordinary routines.
| Arm | Type | Receives |
|---|---|---|
| Assessment of activity limitation | Experimental | Other: Assessment of activity limitations, SDO and DOAAssessment and analysis of activity limitation by occupational therapist using 2 registered instruments (SDO and DOA). |
| Control group: treatment as usual | Active comparator | Other: Control groupAssessment of activity limitations according to usual routines |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients registered at the chosen psychiatric care centers, in need for their second or third sickness certificate within the unit.
Key exclusion criteria (2 listed)
- Patients with specific diagnosis belonging to another unit within the psychiatric organization.
- Patients assessed as being in an acute vulnerable situation where the planned intervention could negatively influence the situation e.g. having suicidal thoughts, or having such language difficulties that an interpreter is needed (which could complicate the understanding of the meaning of the intervention and cause unnecessary worries).
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 |
|---|---|---|
| Assessment of activity limitations, SDO and DOAAlso: Satisfaction with Daily Occupations (SDO), A Dialogue About Ability Realted to Work (DOA)The assessment is made with two instruments (DOA, SDO), and finally the occupational therapist includes the analysis and summary of activity limitations to the sickness certificate. For comparative reasons the participant will answer to a sociodemographic questionnaire focusing on work situation and sick leave | Other | Assessment of activity limitation |
| Control groupAll assessments concerning activity limitations are made using usual routines, primarily by the sick-listing physician. For comparative reasons the participant will answer to a sociodemographic questionnaire focusing on work situation and sick leave | Other | Control group: treatment as usual |
Primary outcome
Health care treatments
Time frame: 6 months after inclusion
Differences in types of healthcare treatment options between intervention and control group. Comparisons will be made between intervention and control group with regard to registered codes for intervention and codes for professionals responsible for treatment options. Descriptive calculations and comparisons will be made on differences in types of as well as changes in treatment measures within the notified time frame.
Changes in sick leave patterns
Time frame: 6 months after inclusion
Differences in number of sick leave periods, full-time or part-time or number of sick leave spells between intervention and control group.
Number of questions from the Social Insurance Agency (SIA)
Time frame: 6 months after inclusion
Differences in number of clarifying questions from SIA between intervention and control group.
1 secondary outcome
Participants self-assessed effects of being part of the project
Time frame: 6 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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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.
Christina Andersson principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of activity limitations, SDO and DOA in people with Sick Leave, 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 1 inclusion and 2 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 6 May 2026. 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?
Health care treatments (time frame: 6 months after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.