Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War 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
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Pristina、科索沃、10000
- Kosova Rehabilitation Centre for Torture Victims
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
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
一般刊物
- Wang SJ, Salihu M, Rushiti F, Bala L, Modvig J. Survivors of the war in the Northern Kosovo: violence exposure, risk factors and public health effects of an ethnic conflict. Confl Health. 2010 May 28;4:11. doi: 10.1186/1752-1505-4-11.
- Wang SJ, Pacolli S, Rushiti F, Rexhaj B, Modvig J. Survivors of war in the Northern Kosovo (II): baseline clinical and functional assessment and lasting effects on the health of a vulnerable population. Confl Health. 2010 Sep 21;4:16. doi: 10.1186/1752-1505-4-16.
- Wang SJ, Rushiti F, Sejdiu X, Pacolli S, Gashi B, Salihu F, Modvig J. Survivors of war in northern Kosovo (III): The role of anger and hatred in pain and PTSD and their interactive effects on career outcome, quality of sleep and suicide ideation. Confl Health. 2012 Jul 30;6(1):4. doi: 10.1186/1752-1505-6-4.
- Wang SJ, Bytyci A, Izeti S, Kallaba M, Rushiti F, Montgomery E, Modvig J. A novel bio-psycho-social approach for rehabilitation of traumatized victims of torture and war in the post-conflict context: a pilot randomized controlled trial in Kosovo. Confl Health. 2017 Feb 8;10:34. doi: 10.1186/s13031-016-0100-y. eCollection 2016.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.