Long Term Sick LeaveGESAMNCT03348410
Joint Coordination to Facilitate the Transition From Sick Leave to Employment
A study testing Motivational interviewing in people with Long Term Sick Leave and Absent-mindedness, run by Uppsala University at 1 site in Sweden.
Trial summary
GESAM is a randomized controlled intervention study that addressed women and men on long-term sick leave in Uppsala County. Participants which are on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance will be offered to participate in an intervention. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Long Term Sick Leave, Absent-mindedness
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteSweden
- Study dates
- 14 Nov 2017to 14 Dec 2019
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- On sick leave
- Risk of losing sick leave compensation
Who cannot join
- Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)
- Cancer disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Joint Coordination (GESAM) - Collaboration Project to Facilitate the Transition From Sick Leave to Employment
GESAM is a randomized controlled intervention study that addressed women and men on long-term sick leave in Uppsala County. Participants which are on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance will be offered to participate in an intervention.
Those how give informed consent will be randomly assigned one of the following groups: 1) informing and motivating intervention with insurance officer 2) control group. The main purpose of the study is to facilitate the return to work (preventing a return to the public health insurance) during the project period.
- Conditions
- Long Term Sick Leave, Absent-mindedness
- Being tested
- Motivational interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Motivational interviewing with insurance officer
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Motivational interviewing Receives: Behavioral: Motivational interviewing |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work (RTW)
Return to work measured as time to participation in the labor force
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start14 Nov 2017
- Primary completion14 Nov 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Sick LeaveStudies of the same condition, open and under way.
- More trials run by Uppsala 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid Anderzén, PHD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348410
- Sponsor's protocol ID
- GESAM2017
- Acronym
- GESAM
- Status last verified
- Oct 2020
- First submitted
- 16 Nov 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Coordination (GESAM) - Collaboration Project to Facilitate the Transition From Sick Leave to Employment
- ClinicalTrials.gov ID
- NCT03348410
- Acronym / sponsor ID
- GESAM / GESAM2017
- Conditions
- Long Term Sick Leave, Absent-mindedness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 20 Nov 2017 (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.
GESAM is a randomized controlled intervention study that addressed women and men on long-term sick leave in Uppsala County. Participants which are on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance will be offered to participate in an intervention.
Those how give informed consent will be randomly assigned one of the following groups: 1) informing and motivating intervention with insurance officer 2) control group. The main purpose of the study is to facilitate the return to work (preventing a return to the public health insurance) during the project period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational interviewingMotivational interviewing |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- On sick leave
- Risk of losing sick leave compensation
Key exclusion criteria (2 listed)
- Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)
- Cancer disease
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 |
|---|---|---|
| Motivational interviewingMotivational interviewing with insurance officer | Behavioural | Intervention |
Primary outcome
Return to work (RTW)
Time frame: One year
Return to work measured as time to participation in the labor force
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 19 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Long Term Sick Leave
RecruitingObservational study
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Musculoskeletal Disorders (MSDs)
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.
Ingrid Anderzén, PHD principal investigator
Uppsala 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 Motivational interviewing in people with Long Term Sick Leave and Absent-mindedness, run by Uppsala 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 2 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: finished, as of the sponsor's last update on 19 Oct 2020. 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?
Return to work (RTW) (time frame: One year). 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 19 Oct 2020.