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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pristina, 코소보, 10000
- Kosova Rehabilitation Centre for Torture Victims
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: BF-CBT and group physiotherapy
Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy
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Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
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활성 비교기: Waiting list
The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later
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Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change of depression symptom from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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Change of anxiety symptom from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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Change of chronic pain symptom from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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Change of anger from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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Change of PTSD symptom from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change of disability scale from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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Change of hand-grip strength from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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Change of standing balance from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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Change of BMI from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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Change of heart rate variability from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Change of reporting sleep disorder from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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Change of reporting suicide ideation from baseline at 3 and 6 months
기간: 0-3-6 months
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0-3-6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shr-Jie Wang, Ph.D., Rehabilitation and Research Centre for Torture Victims
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
BF-CBT and group physiotherapy에 대한 임상 시험
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Istinye University모집하지 않고 적극적으로오스테 오르트 리트 | Eras protokolü | 총 Diz Artroplastisi칠면조
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Charite University, Berlin, GermanyGerman Federal Ministry of Education and Research완전한