Treatment With Cognitive Behavioural Therapy in Traumatised Refugees - Stress Management Versus Cognitive Restructuring - a Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ)
研究概览
简要总结
The Competence Centre for Transcultural Psychiatry is a clinic specialised in the treatment of traumatised refugees. There is a lack of studies on treatment effect in traumatised refugees. There are several studies indicating an effect of cognitive behavioural therapy (CBT) in Posttraumatic Stress Disorder (PTSD). A few studies point to that CBT could be effective in traumatised refugees. There are no studies examining if some methods used in CBT are more useful than others in traumatised refugees. The aim of this study is to examine the effect of CBT with focus on Stress Management versus cognitive restructuring. Patients included in this study will be randomised to either Stress Management or cognitive restructuring. All referred patients will receive medical treatment as usual (described in the clinic's manual for medical doctors, 2011). All patients that fulfill the inclusion criteria will be included in the study. Hopefully this study will contribute to improve the psychotherapeutic treatment offered to traumatised refugees.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refugee or patient that has been reunified with family member being a refugee.
- •Symptoms of PTSD in accordance with International Classification of Diseases-10 (ICD-10) research criteria.
- •Trauma in the past such as imprisonment, torture (according to UN definition), war experiences.
- •Referred by a medical doctor.
- •Motivated for treatment.
- •Informed consent.
排除标准
- •Severe psychotic illness such as schizophrenia or bipolar disorder
- •Drug abuse
- •Patients admitted to in ward treatment
- •No informed consent
结局指标
主要结局
Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ)
时间窗: Baseline, after 2 months and after 6 months
次要结局
- Change in depressive symptoms measured by the Hopkins Symptoms Checklist-25 (HSCL-25), depressive items(Baseline, after 2 months and after 6 months)
- Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety items(Baseline, after 2 months and after 6 months)
- Change in quality of life measured by the WHO-5(Baseline, after 2 months and 6 months)
- Changes in functioning measured by the the Sheehan Disability Scale (SDS)(Baseline, after 2 months and 6 months)
- Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)(After 6 months)
研究者
Jessica Carlsson Lohmann
M.D., Phd
Mental Health Services in the Capital Region, Denmark