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临床试验/NCT03343457
NCT03343457已完成不适用

A Randomized Intervention and Coordination Program Aiming at Return To Work for Women With Long Term Sick Leave

Uppsala University0 个研究点目标入组 400 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
主要终点
Return to work (RTW)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Multidisciplinary assessment

Experimental

Assessment of a team. Cognitive therapy

干预措施: Cognitive therapy (Behavioral)

Control

No Intervention

Control group

Acceptance Commitment Therapy

Experimental

Acceptance Commitment Therapy. Cognitive therapy

干预措施: Cognitive therapy (Behavioral)

结局指标

主要结局

Return to work (RTW)

时间窗: One year

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

次要结局

未报告次要终点

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

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