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临床试验/NCT01926574
NCT01926574Unknown不适用

Evaluation of Inpatient-return- To-work, Multicomponent, Rehabilitation Programs for Persons Temporary Out of Work With Musculoskeletal-, Unspecific-, and/or Common Mental Health Disorders; Randomized Controlled Trial

Norwegian University of Science and Technology2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013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
入组人数
300
试验地点
2
主要终点
time until full sustainable return-to-work (RTW)

研究概览

简要总结

Long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole. Hence, the need for documented effective vocational rehabilitation programs is pressing. Vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain). In contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g. social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal-, unspecific- and common mental disorders. Aim of this study is to investigate whether a group based rehabilitation program for musculoskeletal, mental or unspecific complaints can facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW rehabilitation programs.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •living in the counties of Trøndelag
  • •on sick leave 2-12 months
  • •current sick leave status of 50% - 100%
  • •ICPC-2 (International Classification of Primary Care, Second edition) diagnosis within the L (musculoskeletal), P (psychiatric) or A (unspecific disorders) categories

排除标准

  • •alcohol or drug abuse
  • •serious somatic or psychological disorders
  • •a specific disorder requiring specialized treatment
  • •pregnancy
  • •currently participating in another treatment program
  • •insufficient Norwegian speaking or writing skills to participate in group session and fill out questionnaires
  • •scheduled for surgery within the next 6 months
  • •serious problems with functioning in a group setting

研究组 & 干预措施

long rehabilitation

Experimental

a 3.5-week, in-patient rehabilitation program, organized as a 7-hour workday with weekends off, simulating a close to normal summer work-week in Norway, and mainly group-based with maximum 8 participants per group. Focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving.

干预措施: long rehabilitation program (Behavioral)

short rehabilitation

Experimental

4+4 full days of rehabilitation at Hysnes Rehabilitation Center, separated by 2 weeks living at home. Group-based with 8 participants per group, focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving. A workplace visit will be included in addition to the 4 + 4 rehabilitation days, if considered relevant.

干预措施: short rehabilitation program (Behavioral)

Acceptance and commitment therapy

Active Comparator

6 dynamic processes (committed action, self-as-context, presence in the moment, values, defusion and acceptance) are targeted both in group-sessions and individual meetings. Only the psychological part of the experimental interventions is applied, in an outpatient setting.

干预措施: Acceptance and commitment therapy (ACT) (Behavioral)

Untouched

No Intervention

this group will be followed in registers at group level and not be aware of their participation in the study

结局指标

主要结局

time until full sustainable return-to-work (RTW)

时间窗: 1 year

return-to-work i.e. for at least 4 weeks without relapse

Total number of sickness absence days

时间窗: 1 year

after enrollment in the study (i.e. after pre-screening)

次要结局

  • Sickness absence days(3 years)
  • fear avoidance beliefs(1 year)
  • sickness absence days(5 years)
  • Health related quality of life(1 year)
  • Subjective health complaints(1 year)
  • Physical activity(1 year)
  • physical, social and emotional functional status(1 year)
  • Psychological and social factors at work(1 year)
  • psychological flexibility and acceptance(1 year)
  • share of workers at work(1 year)
  • readiness for return to work(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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