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Return To Work for People on Long Term Sick Leave (Vitalis)

Primary Purpose

Anxiety, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive therapy
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Chronic Pain

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Acceptance Commitment Therapy

    Multidisciplinary assessment

    Control

    Arm Description

    Acceptance Commitment Therapy. Cognitive therapy

    Assessment of a team. Cognitive therapy

    Control group

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2017
    Last Updated
    November 15, 2017
    Sponsor
    Uppsala University
    Collaborators
    Region Stockholm
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03343457
    Brief Title
    Return To Work for People on Long Term Sick Leave
    Acronym
    Vitalis
    Official Title
    A Randomized Intervention and Coordination Program Aiming at Return To Work for Women With Long Term Sick Leave
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    December 31, 2012 (Actual)
    Study Completion Date
    December 31, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Uppsala University
    Collaborators
    Region Stockholm

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Chronic Pain
    Keywords
    Anxiety, Chronic Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acceptance Commitment Therapy
    Arm Type
    Experimental
    Arm Description
    Acceptance Commitment Therapy. Cognitive therapy
    Arm Title
    Multidisciplinary assessment
    Arm Type
    Experimental
    Arm Description
    Assessment of a team. Cognitive therapy
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control group
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive therapy
    Other Intervention Name(s)
    ACT, multidisciplinary assessment
    Primary Outcome Measure Information:
    Title
    Return to work (RTW)
    Description
    Return to work measured as self-reported change in working hours
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Return To Work for People on Long Term Sick Leave

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