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肌肉骨骼疼痛和常见心理健康障碍的职业康复计划:一项随机对照试验的研究方案

Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial.

作者信息

Fimland Marius S, Vasseljen Ottar, Gismervik Sigmund, Rise Marit By, Halsteinli Vidar, Jacobsen Henrik B, Borchgrevink Petter C, Tenggren Hanne, Johnsen Roar

机构信息

Department of Public Health and General Practice, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway.

出版信息

BMC Public Health. 2014 Apr 16;14:368. doi: 10.1186/1471-2458-14-368.

Abstract

BACKGROUND

Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group.

METHODS/DESIGN: The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18-60 years, on sick leave 2-12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter "untouched" control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½ weeks with full rehabilitation days. The Short program consists of 4 + 4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and mental health, and perceptions of work. In addition, health economic evaluation will be performed, and the implementation of the interventions, expectations and experiences of users and service providers will be investigated with different qualitative methods.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT01926574.

摘要

背景

长期病假对个人和社会都有相当大的负面影响。因此,确定有效的职业康复计划迫在眉睫。在挪威,将不同诊断的患者合并在一起的基于小组的职业康复计划已经存在多年,但尚未进行严格的评估。所描述的随机对照试验主要旨在比较两个结构化的多成分住院康复计划(在长度和内容上有所不同)与一个对照认知干预。其次,将这两个住院计划相互比较,并与一个常规护理参考组进行比较。

方法/设计:该研究设计为平行组随机对照试验。社会保障办公室每月提取18至60岁、病假2至12个月、因肌肉骨骼、精神或非特异性疾病病假状态为50%至100%的病假人员名单。病假人员被随机分组两次:1)接受两项参与研究邀请中的一项或不接受邀请,后者“未受影响”的对照组将在国家社会保障登记册中监测未来病假情况;2)纳入研究后,随机分配到长疗程或短疗程住院多成分康复计划(取决于发送的是哪项邀请)或门诊认知行为治疗组对照计划。长疗程计划包括3.5周的全天康复。短疗程计划包括4 + 4个全天,中间间隔两周,如有需要将进行一次工作场所访问。康复针对三个领域:心理训练、体能训练和与工作相关的问题解决。主要结局是病假天数。次要结局包括完全可持续重返工作的时间、与健康相关的生活质量、与健康相关的行为、功能状态、身心健康以及对工作的认知。此外,将进行健康经济评估,并采用不同的定性方法调查干预措施的实施情况、用户和服务提供者的期望及体验。

试验注册

ClinicalTrials.gov:NCT01926574。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b11/3996166/9a5bab2b41d6/1471-2458-14-368-1.jpg

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