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临床试验/NCT01696578
NCT01696578已完成不适用

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

Rehabilitation and Research Centre for Torture Victims2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2012年1月1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
31
试验地点
2
主要终点
Change of anxiety symptom from baseline at 3 and 6 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change of anxiety symptom from baseline at 3 and 6 months

时间窗: 0-3-6 months

Change of chronic pain symptom from baseline at 3 and 6 months

时间窗: 0-3-6 months

Change of PTSD symptom from baseline at 3 and 6 months

时间窗: 0-3-6 months

Change of depression symptom from baseline at 3 and 6 months

时间窗: 0-3-6 months

Change of anger from baseline at 3 and 6 months

时间窗: 0-3-6 months

次要结局

  • Change of heart rate variability from baseline at 3 and 6 months(0-3-6 months)
  • Change of disability scale from baseline at 3 and 6 months(0-3-6 months)
  • Change of hand-grip strength from baseline at 3 and 6 months(0-3-6 months)
  • Change of standing balance from baseline at 3 and 6 months(0-3-6 months)
  • Change of BMI from baseline at 3 and 6 months(0-3-6 months)

研究者

发起方
Rehabilitation and Research Centre for Torture Victims
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shr-Jie Wang

Principal investigator

Rehabilitation and Research Centre for Torture Victims

研究点 (2)

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