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临床试验/NCT03951909
NCT03951909进行中(未招募)不适用

Effect of Physiotherapy and Psychological Group Treatment on Physical and Mental Health Among Refugees From Syria With Pain Disorders or Post-traumatic Symptoms

University of Bergen2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
180
试验地点
2
主要终点
Change in body pain index using Body Pain Inventory

研究概览

简要总结

The war in Syria began in 2011 and refugees from this country have faced stressors including security risks, lack of access and availability of basic services and resources as well as family, community, and socio political tensions. Exposure to stressful events or situations, either short or long lasting, of exceptionally threatening or catastrophic nature is likely to cause pervasive distress in almost anyone, which might disturb daily life function, integration in society and ability to function in work and society, although this stress does not necessarily need to become an established medical diagnose. For a long time now, somatic and mental health systems have been overburdened and inaccessible both in Syria and in transit countries, and there is little available evidence of the effect of interventions targeting common health problems among refugees once established in their host countries.

In this project, the University of Bergen, in close collaboration with the Centre for Migration Health (Bergen municipality) and the Centre for Crisis Psychology, have developed two treatment interventions that are both theoretically sound and practically scalable if shown to be effective.

Among resettled asylum seekers and refugees, the primary aim of the project is to separately study in a quantitative way the effect on both physical and mental health of two different interventions: Physiotherapy activity and awareness intervention for participants with pain disorders and Teaching recovery techniques for participants with post-traumatic symptoms In addition, in a qualitative mode, our secondary aim is to analyse the processes by which the interventions help/do not help the patients to improve their health. Last, as the third aim of the study, cost effectiveness analyses will be conducted.

详细描述

Introduction Syria is now the 11th country of origin for immigrants in Norway. During the last two years, the numbers of asylum seekers from Syria with permanent refugee status have rapidly grown from 9700 in 2016 to a total of 20800 registered by the 1st of January 2017. Given that more than 1 million Syrians applied for asylum in Europe between April and December 2017, the numbers are probably going to continue growing also in Norway in the months to come.

Impact of stress on health The war in Syria began in 2011 and refugees from this country have faced stressors including security risks, lack of access and availability of basic services and resources as well as family, community, and socio political tensions. Exposure to stressful events or situations, either short or long lasting, of exceptionally threatening or catastrophic nature is likely to cause pervasive distress in almost anyone, which might disturb daily life function, integration in society and ability to function in work and society, although this stress does not necessarily need to become an established medical diagnose. For a long time now, somatic and mental health systems have been overburdened and inaccessible both in Syria and in transit countries. Although our knowledge of the health needs of refugees is still incomplete, several studies suggest a high degree of chronic pain disorders and mental health symptoms as a result of the previous factors.

Arthrosis, arthritis and other forms for chronic pain are especially disabling among the chronic non-communicable diseases and have previously been described to be related to mental health problems. Though there is a lack of data regarding these conditions, some available studies point to a relatively high prevalence among refugees from Syria. Just to point out some examples: Among young Syrian refugees attending an emergency department in Austria between 2011 and 2014, 12% presented chronic musculoskeletal problems and 9% suffered from chronic headaches. A cross-sectional survey of 1550 refugees conducted outside of camps in Jordan found a prevalence of 7% of arthritis. In the previously referred paper on elderly Syrians, 47% reported difficulty walking.

Regarding mental problems, 61% of older refugees from Syria living in Lebanon in 2011-2013 reported feeling anxious, and significant proportions reported feelings of depression, loneliness, and believing they were a burden to their families. In another study, 44% of 310 Syrian forced migrants in Lebanon in 2011 suffered from depression. In 2014, 54% of Syrians accessing International Medical Corps facilities in Syria and neighbouring countries suffered severe emotional disorders, including depression and anxiety.

Once resettled in Norway, the municipalities have the responsibility to offer adequate health care services to refugees in need of health care. However, lack of evidence regarding the best treatment together with limited resources may compromise the offer given to refugees. Group treatment can be a strategy to maximize the effect of the treatment given the resources typically available at the municipalities for this group of patients, as well as a mean to increase social interaction and well-being among participants.

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

盲法说明

Neither the participant or th researcher knew the intervention assignment before enrollment, but there were no masking afterwards (when they had been assigned to either physiotherapy or TRT)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who answer yes to the question "Have you experienced any of these or some other terrifying event(s)?" and score over 24 in the revised Impact of Events Scale (R-IES) will be invited to the TRT-intervention.

排除标准

  • Patients who report health conditions requiring close medical follow up
  • Patients who score in the mental health questions as having a serious mental illness (37 + in the revised Impact of Events Scale or 25 or more in the GHQ-12)
  • Patients with a living situation that impedes following up (including no current address close to Bergen).

结局指标

主要结局

Change in body pain index using Body Pain Inventory

时间窗: At recruitment, right before and after the intervention and 12 weeks afterwards

Pain intensity measures through four questions: worst pain, least pain, average pain, pain right now). Each question can answers with 1 to 10 points and will be measured separately

Change in Impact of Events Scale

时间窗: At recruitment, right before and after the intervention and 12 weeks afterwards

Scores in the Impact of Events-Revised scale. The revised version of the Impact of Event Scale has 22 questions and a scoring range of 0 to 88. Low scores are considered as better outcomes. Scores of 24 or more are of clinical concern and 33 and above is the cutoff for a probable diagnoses of post traumatic stress disorder(PTSD)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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