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Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War Victims

2014年4月23日 更新者:Shr-Jie Wang、Rehabilitation and Research Centre for Torture Victims

Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in Victims of Torture and Massive Violence in Kosovo: A Randomized Controlled Trial

This study will measure the effects of biofeedback supported cognitive behavioral therapy (BF-CBT) and group physiotherapy intervention in victims of torture and massive violence in Kosovo. The investigators aim to restore physical and psychosocial functioning of the victims of torture and massive violence with available rehabilitation practice and integrate them into the community. It is also our objective to build local knowledge and expertise to apply measurement principles and CBT methods in the Balkan region.

研究概览

详细说明

The primary objective of this project is to contribute to the promotion of evidence-based health intervention which is dealing with the long-term consequences of trauma in the post-conflict Kosovo.

This is the second phase of a series of multi-site case studies. Based on the knowledge generated in the first phase of project in 2007-2009, the investigators conclude that there is a need to continue with health interventions in northern Kosovo among those who are still suffering from the long-term effects of trauma. Many problems need to be addressed, ranging from unemployment and sleep disturbances to a high suicide rate. As our study shows, the situation is frequently complicated by co-morbidity between mental and physical problems, in particular, anger, hatred, severe depression and chronic pain.

At this phase, the investigators aim to provide the available rehabilitation service to the victims of torture and massive violence in northern Kosovo. The investigators undertake an integrated intervention approach; that is a biofeedback supported cognitive-behavioral therapy (BF-CBT), which involves anger management, anxiety and phobia treatment (based on prolong exposure therapy)and a group physiotherapy intervention, which promotes physical fitness and social participation. The ultimate goal of this project is to determine both feasibility and the effectiveness of combined interventions in the countries with limited resources.

研究类型

介入性

注册 (实际的)

31

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Pristina、科索沃、10000
        • Kosova Rehabilitation Centre for Torture Victims

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Victims of massive violence from northern Kosovo who reported one or more of the following experiences: 1) torture and other cruel, inhuman or degrading treatment or punishment (TCIDTP); 2) sexual harassment, molestation, rape or insertion of a blunt object into a genital organ and/or the rectum; 3) arrest and detention without warrant or order; or 4) extrajudicial execution of family members, perpetrated by members of law enforcement agency.
  • Clinical diagnosis of PTSD and one of following symptoms: depression, anxiety or chronic pain

Exclusion Criteria:

  • With mental retardation or significant speech or cognitive impairment that would impede assessments
  • With past or present schizophrenia
  • With major alcoholic or substance abuse problems
  • Having recently undergone chemotherapy or chemo-radiotherapy for cancer or will have these therapy within following 6 months,
  • Having had any CBT in the past three years

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:BF-CBT and group physiotherapy
Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy
Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
有源比较器:Waiting list
The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later
Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change of depression symptom from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months
Change of anxiety symptom from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months
Change of chronic pain symptom from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months
Change of anger from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months
Change of PTSD symptom from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months

次要结果测量

结果测量
大体时间
Change of disability scale from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months
Change of hand-grip strength from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months
Change of standing balance from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months
Change of BMI from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months
Change of heart rate variability from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months

其他结果措施

结果测量
大体时间
Change of reporting sleep disorder from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months
Change of reporting suicide ideation from baseline at 3 and 6 months
大体时间:0-3-6 months
0-3-6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Shr-Jie Wang, Ph.D.、Rehabilitation and Research Centre for Torture Victims

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2014年4月1日

研究注册日期

首次提交

2012年9月25日

首先提交符合 QC 标准的

2012年9月27日

首次发布 (估计)

2012年10月1日

研究记录更新

最后更新发布 (估计)

2014年4月24日

上次提交的符合 QC 标准的更新

2014年4月23日

最后验证

2014年4月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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