- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01696578
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pristina, Kosovo, 10000
- Kosova Rehabilitation Centre for Torture Victims
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Change of depression symptom from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
|
Change of anxiety symptom from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
|
Change of chronic pain symptom from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
|
Change of anger from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
|
Change of PTSD symptom from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Change of disability scale from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
|
Change of hand-grip strength from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
|
Change of standing balance from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
|
Change of BMI from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
|
Change of heart rate variability from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
|
Change of reporting sleep disorder from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
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Change of reporting suicide ideation from baseline at 3 and 6 months
Prazo: 0-3-6 months
|
0-3-6 months
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Shr-Jie Wang, Ph.D., Rehabilitation and Research Centre for Torture Victims
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RCTF5S2P4D1
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