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临床试验/NCT04065126
NCT04065126已完成不适用

Physical Activity Intervention for Trauma Afflicted Refugees

Swedish Red Cross University College2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2018年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
183
试验地点
2
主要终点
Change in symptoms of PTSD

研究概览

简要总结

This study evaluates the effects of a 10-session physical activity intervention for trauma afflicted refugees. Half of participants will receive this 10-session physical activity intervention and half of the participants will be allocated to the control group.

详细描述

Physical activity, particularly when performed in social settings, has been found to constitute an effective stress reliever and has been associated with improved physical and mental well-being, functional capacity and overall life satisfaction, as well as decreased risk of lifestyle diseases in various populations. Physical activity can also revert symptoms of psychiatric disorders such as depression, anxiety, social isolation and dissociation, which is common among trauma afflicted refugees. Many refugees also suffer from PTSD, and so the investigator's aim is to evaluate what effect a 10-session physical activity intervention will have on the mental and physical health of trauma afflicted refugees in a northern European country. The sessions will include physical exercise as well as psychoeducational components, and will be held by a physiotherapist over a period of ten weeks. The physical activity intervention group will be compared to a control-group, who receives two brief lectures on psycho-education in connection to baseline-assessment and follow-up.

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
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Arabic/Persian speaking persons.
  • Persons with refugee background referred to the Swedish Red Cross Treatment Center for trauma related to war and/or torture.
  • Person able to undertake physical activity in a group setting.

排除标准

  • Current serious suicidal ideation, psychosis, serious cognitive impairments, current substance abuse, acute physical injuries or other health conditions that constrain physical activity.

结局指标

主要结局

Change in symptoms of PTSD

时间窗: Baseline, 10 weeks, and six months

Change in symptoms of PTSD measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5). The PCL-5 is a self-report questionnaire comprising 20 items relating to the main symptoms of PTSD, and which may be divided into the four symptom clusters of PTSD; intrusion, hyperarousal/reactivity, avoidance, and negative alterations in cognitions and mood. Scores range between 0-80. Higher score indicate worse outcome. Initial research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD across samples.

次要结局

  • Health related quality of life(Baseline, 10 weeks, and six months)
  • Emotional distress(Baseline, 10 weeks, and six months)
  • Subjective well-being(Baseline, 10 weeks, and six months)

研究者

发起方
Swedish Red Cross University College
申办方类型
Other
责任方
Sponsor

研究点 (2)

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