AnxietyVitalisNCT03343457
Return To Work for People on Long Term Sick Leave
A study testing Cognitive therapy in people with Anxiety and Chronic Pain, run by Uppsala University.
Trial summary
Vitalis was a randomized controlled intervention study that addressed women on long-term sick leave in Uppsala County. Participants were on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Anxiety, Chronic Pain
- What is being tested?
- Cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2012
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- On sick leave for mental illness and/or chronic pain
Who cannot join
- High risk for suicide
- Ongoing alcohol/substance abuse
- Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)
- Participation in psychotherapy or another vocational rehabilitation program.
About this study
Official title: A Randomized Intervention and Coordination Program Aiming at Return To Work for Women With Long Term Sick Leave
Vitalis was a randomized controlled intervention study that addressed women on long-term sick leave in Uppsala County. Participants were on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance. Of the total of 947 eligible reaching the time limit during 2010-2012 648 persons met the projects inclusion- and exclusion criteria and were invited to participate. Of these, 327 persons (50.4%) gave informed consent and was thereafter randomly assigned one of the following groups: 1) multimodal treatment team (TEAM) 2) psychotherapy with Acceptance and Commitment Therapy (ACT), or 3) control group. The main purpose of the study was to facilitate the return to work (preventing a return to the public health insurance) and to improve participants' health during the project period of one year.
Read the detailed description
Vitalis was a randomized controlled intervention study that addressed women on long-term sick leave in Uppsala County. Participants were on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance. Of the total of 947 eligible reaching the time limit during 2010-2012 648 persons met the projects inclusion- and exclusion criteria and were invited to participate. Of these, 327 persons (50.4%) gave informed consent and was thereafter randomly assigned one of the following groups: 1) multimodal treatment team (TEAM) 2) psychotherapy with Acceptance and Commitment Therapy (ACT), or 3) control group. The main purpose of the study was to facilitate the return to work (preventing a return to the public health insurance) and to improve participants' health during the project period of one year.
The participants of the TEAM group received individual meetings/assessments with a doctor, psychologist, occupational therapist and social worker, each assessing the participant's problems in relation to the return to work goal. The TEAM then worked out an individualized plan of actions/treatments, which then was presented to the participant. Suggested and accepted actions were psychotherapy (60%, average 9.2 sessions); Occupational Therapist (72%, average 3.7 sessions); social worker (36%, average 6.5 sessions) and further medical investigations/referrals initiated by physicians (41%).
In the ACT group all participants received psychotherapy with ACT with an average of 10.0 sessions (range 1-23) during the project year.
In addition to the medical assessment/treatments all participants in the intervention groups also participated in scheduled collaboration meetings with representatives from the health insurance agency and employment office in order to establish an agreement and justification on the rehabilitation goals. The participant and a health professional from the project participated in these collaborations meetings.
During the project year the participants filled in questionnaire at three points in time in which they rated their views on returning to work as well as various aspects of their health. Data whether the participants had returned to the health insurance as well as the number of reimbursed days during the first years, was collected from the health insurance register after one year.
- Conditions
- Anxiety, Chronic Pain
- Being tested
- Cognitive therapy
- Keywords
- Anxiety, Chronic Pain
- Medical subject headings
- Anxiety Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive therapyBehavioural
Also called ACT, multidisciplinary assessment
| Study group | Role | What they receive |
|---|---|---|
| Acceptance Commitment Therapy | Experimental | Acceptance Commitment Therapy. Cognitive therapy Receives: Behavioral: Cognitive therapy |
| Multidisciplinary assessment | Experimental | Assessment of a team. Cognitive therapy Receives: Behavioral: Cognitive therapy |
| 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 self-reported change in working hours
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 posted17 Nov 2017
- Study start1 Jan 2010
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343457
- Sponsor's protocol ID
- VITALIS 2010
- Acronym
- Vitalis
- Status last verified
- Nov 2017
- First submitted
- 30 Oct 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Finnes A, Johansson M, Helgesson M, Andersen A, Berglund E, Anderzen I. Long-term health- and cost evaluation of two work-oriented rehabilitation models for women on long-term work disability due to common mental disorders or chronic pain - a randomized controlled trial. BMC Public Health. 2026 May 6;26(1):1478. doi: 10.1186/s12889-026-27634-4.
PubMed 42087116Berglund E, Anderzen I, Helgesson M, Lytsy P, Andersen A. Work participation after receiving multidisciplinary treatment or acceptance and commitment therapy intervention for return to work: long-term follow-up of a randomized controlled trial among sick-listed individuals with mental disorders and/or chronic pain. BMC Public Health. 2024 Dec 21;24(1):3558. doi: 10.1186/s12889-024-21116-1.
PubMed 39709368
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Intervention and Coordination Program Aiming at Return To Work for Women With Long Term Sick Leave
- ClinicalTrials.gov ID
- NCT03343457
- Acronym / sponsor ID
- Vitalis / VITALIS 2010
- Conditions
- Anxiety, Chronic Pain
- Keywords
- Anxiety, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 17 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.
Vitalis was a randomized controlled intervention study that addressed women on long-term sick leave in Uppsala County. Participants were on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance. Of the total of 947 eligible reaching the time limit during 2010-2012 648 persons met the projects inclusion- and exclusion criteria and were invited to participate. Of these, 327 persons (50.4%) gave informed consent and was thereafter randomly assigned one of the following groups: 1) multimodal treatment team (TEAM) 2) psychotherapy with Acceptance and Commitment Therapy (ACT), or 3) control group. The main purpose of the study was to facilitate the return to work (preventing a return to the public health insurance) and to improve participants' health during the project period of one year.
Detailed description
Vitalis was a randomized controlled intervention study that addressed women on long-term sick leave in Uppsala County. Participants were on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance. Of the total of 947 eligible reaching the time limit during 2010-2012 648 persons met the projects inclusion- and exclusion criteria and were invited to participate. Of these, 327 persons (50.4%) gave informed consent and was thereafter randomly assigned one of the following groups: 1) multimodal treatment team (TEAM) 2) psychotherapy with Acceptance and Commitment Therapy (ACT), or 3) control group. The main purpose of the study was to facilitate the return to work (preventing a return to the public health insurance) and to improve participants' health during the project period of one year.
The participants of the TEAM group received individual meetings/assessments with a doctor, psychologist, occupational therapist and social worker, each assessing the participant's problems in relation to the return to work goal. The TEAM then worked out an individualized plan of actions/treatments, which then was presented to the participant. Suggested and accepted actions were psychotherapy (60%, average 9.2 sessions); Occupational Therapist (72%, average 3.7 sessions); social worker (36%, average 6.5 sessions) and further medical investigations/referrals initiated by physicians (41%).
In the ACT group all participants received psychotherapy with ACT with an average of 10.0 sessions (range 1-23) during the project year.
In addition to the medical assessment/treatments all participants in the intervention groups also participated in scheduled collaboration meetings with representatives from the health insurance agency and employment office in order to establish an agreement and justification on the rehabilitation goals. The participant and a health professional from the project participated in these collaborations meetings.
During the project year the participants filled in questionnaire at three points in time in which they rated their views on returning to work as well as various aspects of their health. Data whether the participants had returned to the health insurance as well as the number of reimbursed days during the first years, was collected from the health insurance register after one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acceptance Commitment Therapy | Experimental | Behavioral: Cognitive therapyAcceptance Commitment Therapy. Cognitive therapy |
| Multidisciplinary assessment | Experimental | Behavioral: Cognitive therapyAssessment of a team. Cognitive therapy |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- On sick leave for mental illness and/or chronic pain
Key exclusion criteria (4 listed)
- High risk for suicide
- Ongoing alcohol/substance abuse
- Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)
- Participation in psychotherapy or another vocational rehabilitation program.
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 |
|---|---|---|
| Cognitive therapyAlso: ACT, multidisciplinary assessment | Behavioural | Acceptance Commitment Therapy, Multidisciplinary assessment |
Primary outcome
Return to work (RTW)
Time frame: One year
Return to work measured as self-reported change in working hours
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 17 Nov 2017.
- Derived from this study: PubMed 42087116Finnes A, Johansson M, Helgesson M, Andersen A, Berglund E, Anderzen I. Long-term health- and cost evaluation of two work-oriented rehabilitation models for women on long-term work disability due to common mental disorders or chronic pain - a randomized controlled trial. BMC Public Health. 2026 May 6;26(1):1478. doi: 10.1186/s12889-026-27634-4.
- Derived from this study: PubMed 39709368Berglund E, Anderzen I, Helgesson M, Lytsy P, Andersen A. Work participation after receiving multidisciplinary treatment or acceptance and commitment therapy intervention for return to work: long-term follow-up of a randomized controlled trial among sick-listed individuals with mental disorders and/or chronic pain. BMC Public Health. 2024 Dec 21;24(1):3558. doi: 10.1186/s12889-024-21116-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive therapy in people with Anxiety and Chronic Pain, run by Uppsala University.
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 4 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
On the ClinicalTrials.gov record for NCT03343457, which also lists 2 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 17 Nov 2017.