Return To Work for People on Long Term Sick Leave

Not Applicable

Completed

• Conditions: Anxiety; Chronic Pain
• Interventions: Behavioral: Cognitive therapy

• Registration Number: NCT03343457
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2012-12-31
• Study Completion: 2012-12-31
• Study First Submitted: 2017-10-30
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-14
• Last Update Submitted: 2017-11-15
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multidisciplinary assessment	Cognitive therapy	Assessment of a team. Cognitive therapy
Acceptance Commitment Therapy	Cognitive therapy	Acceptance Commitment Therapy. Cognitive therapy

Primary Outcome Measures

Name	Time	Method
Return to work (RTW)	One year	Return to work measured as self-reported change in working hours