Return To Work for People on Long Term Sick Leave

NCT ID: NCT03343457

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-01

Study Completion Date

2012-12-31

Brief Summary

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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

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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

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Anxiety Chronic Pain

Keywords

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Anxiety Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acceptance Commitment Therapy

Acceptance Commitment Therapy. Cognitive therapy

Group Type EXPERIMENTAL

Cognitive therapy

Intervention Type BEHAVIORAL

Multidisciplinary assessment

Assessment of a team. Cognitive therapy

Group Type EXPERIMENTAL

Cognitive therapy

Intervention Type BEHAVIORAL

Control

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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ACT, multidisciplinary assessment

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Berglund 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.

Reference Type DERIVED
PMID: 39709368 (View on PubMed)

Other Identifiers

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VITALIS 2010

Identifier Type: -

Identifier Source: org_study_id