ClinicalTrials.gg
CompletedNCT03343457VitalisUpdated Nov 17, 2017

Return To Work for People on Long Term Sick Leave

An interventional study of Cognitive therapy in Anxiety and Chronic Pain, sponsored by Uppsala University. Completed. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2017-11-17.

Primary conditionChronic PainRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Chronic Pain
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Chronic Pain.
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 Uppsala University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 9 months after the study started (first participant enrolled Jan 2010, registered Oct 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Chronic Pain by Uppsala University — 3 open to participants now, 3 under way, none of them phase 3. Chronic Pain · Uppsala University.

Started
2010
the only one that year
No phase
8 of 15
1 open now
Registered
4th of 15
by date

Among the 15 studies in Chronic Pain by Uppsala University, this one is the only one that started in 2010, is one of 8 with no phase, and was the 4th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

3 of the 15 studies in Chronic Pain by Uppsala University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 20 Years to 64 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Chronic Pain by Uppsala University, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Anxiety
  • Chronic Pain

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Keywords

  • Anxiety
  • Chronic Pain
04

In context

Chronic Pain Reclassified

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

This study's enrollment of 400 is above the median of 60 across 2,387 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.

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

05

Who can participate

Ages eligible
20 Years to 64 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

  • On sick leave for mental illness and/or chronic pain

Exclusion criteria

Exclusion Criteria:

  • 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.
06

Study design

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

Study arms

  • Experimental
    Acceptance Commitment Therapy

    Acceptance Commitment Therapy. Cognitive therapy

    Behavioral: Cognitive therapy

  • Experimental
    Multidisciplinary assessment

    Assessment of a team. Cognitive therapy

    Behavioral: Cognitive therapy

  • No intervention
    Control

    Control group

Interventions

  • BehavioralCognitive therapy

    Also known as: ACT, multidisciplinary assessment

07

What researchers measure

Primary outcomes

  1. Return to work (RTW)

    Return to work measured as self-reported change in working hours

    Time frame: One year

08

Study locations

No study locations are listed for this record.

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 Jan 2010 to primary completion in Dec 2012, 35 months.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 35 months is above that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

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

Registered
Oct 30, 2017
First posted
Nov 17, 2017
StartActual
Jan 1, 2010
Primary completionActual
Dec 31, 2012
CompletionActual
Dec 31, 2012
Last update
Nov 17, 2017
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 Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03343457
Lead sponsor
Uppsala University
Collaborators
Region Stockholm
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Jan 1, 2010
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012
Last update
Nov 17, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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