跳至主要内容
临床试验/NCT05651737
NCT05651737已完成不适用

Efficacy of an Unguided or Peer-guided App-based Psychosocial Intervention to Enhance Quality of Life in Arabic-speaking Refugees Residing in Switzerland: A Randomized Controlled Trial

University of Bern2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2022年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
2
主要终点
Well-being at baseline

研究概览

简要总结

The ongoing warfare and economic instability in the Middle East and in North Africa causes many people to leave their home countries. Arrived in a host countries, in this example, in Switzerland, they face a lot of structural and psychosocial hurdles. Particularly in the first years, building up a certain quality of life is complicated and challenging. To support this process, the Swiss Red Cross and the University of Bern have developed the Sui app. It contains structural and social information as well as low-intensity psychological tools to provide support to the everyday life of Arabic-speaking people in Switzerland.

研究设计

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

入排标准

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

入选标准

  • At least 18 years old
  • Arabic as native or second language
  • Good knowledge of reading, writing and speaking Arabic
  • Have lived in Switzerland for no longer than 5 years
  • Give written consent
  • Have access to a smartphone and an internet connection
  • Indicate an emergency contact whom they could contact in event of a crisis

排除标准

  • Indicate an increased risk of self-harm or suicide at baseline
  • Indicate having been diagnosed with psychosis or bipolar disorder
  • Be participating in a similar study at baseline
  • Have a lack of written and spoken Arabic skills

结局指标

主要结局

Well-being at baseline

时间窗: Baseline

Measured by the WHO Quality of Life Short Version (WHOQOL-BREF, 4 domain scores, mean score multiplied by 4, 0 (low) to 100 (high) range)

Well-being at follow-up timepoint

时间窗: Follow-Up (after 16 weeks)

Measured by the WHO Quality of Life Short Version (WHOQOL-BREF, 4 domain scores, mean score multiplied by 4, 0 (low) to100 (high) range)

Well-being at post-intervention timepoint

时间窗: Post (after 8 weeks)

Measured by the WHO Quality of Life Short Version (WHOQOL-BREF, 4 domain scores, mean score multiplied by 4, 0 (low) to 100 (high) range)

次要结局

  • Depressive symptoms(Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks))
  • Satisfaction with the treatment(Post (after 8 weeks), Follow-Up (after 16 weeks))
  • Self-stigma(Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks))
  • PTSD symptoms(Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks))
  • Somatic symptoms(Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks))
  • Anxiety symptoms(Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks))
  • Post migration stressors(Baseline, Post (after 8 weeks), Follow-Up (after 16 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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