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
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Chronic Pain
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.
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
NCT ID
NCT03343457
First Posted
October 30, 2017
Last Updated
November 15, 2017
Sponsor
Uppsala University
Collaborators
Region Stockholm
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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