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临床试验/NCT05055037
NCT05055037已完成不适用

Exploring the Feasibility of Neurofeedback for Trauma-affected Refugees - a Qualitative Study

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年11月22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
32
试验地点
2
主要终点
Harvard Trauma Questionnaire (HTQ)

研究概览

简要总结

Neurofeedback (NF) is a form of treatment that can assist individuals in learning to control their brain wave activity. NF-studies have shown promising results in reducing PSTD-symptoms among military veterans, but there are no published peer-reviewed studies with refugees. However, preliminary studies from Malmö and Sydney indicate that refugees could benefit from NF. Therefore, at the Competence Centre for Transcultural Psychiatry (CTP) a longitudinal feasibility study, testing NF for trauma-affected was started. The study contains both a quantitative and a qualitative substudy. In in the quantitative substudy, where a total of 32 participants have been included, the aim was to evaluate the feasibility of NF with trauma affected refugees using a quantitative perspective. The NF intervention offered was 12 training sessions of 12-20 minutes NF, and the outcome measures were self-administered questionnaires and semi-structured interviews collected before and after the intervention. In a subsample of eight participants of those included in the quantitative substudy, qualitative in-depth interviews were carried out. The participants were offered two interviews; one before the first NF training and one during the treatment course. The aim of the qualitative substudy was to evaluate the feasibility of NF with trauma-affected refugees by examining the participants' thoughts and expectations prior to participating in NF treatment as well as their experience with the treatment after a few sessions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
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

  • Refugee or a person who had been family reunified with a refugee
  • Diagnosed with PTSD (ICD-10 diagnosis F43.1) and experienced a psychological trauma in another country than Denmark.
  • Informed consent.

排除标准

  • Current abuse of drug or alcohol (F1x.24-F1x.26)
  • Diagnosed with a severe psychotic disorder (F2x) or a manic disorder (F30.1-F31.9).
  • No informed consent.

结局指标

主要结局

Harvard Trauma Questionnaire (HTQ)

时间窗: Baseline and after 12 weeks

Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire

次要结局

  • WHO-Five Well-being Index (WHO-5)(Baseline and after 12 weeks)
  • Hamilton interview-based rating scales for depression (Ham-D) and anxiety (Ham-A)(Baseline and after 12 weeks)
  • Hopkins Symptom Checklist-25 (HSCL-25)(Baseline and after 12 weeks)
  • Sheehan Disability Scale (SDS)(Baseline and after 12 weeks)
  • Satisfaction and Accept-ability Questionnaire (SAQ)(After 12 weeks)

研究者

发起方
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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