Treatment of Traumatised Refugees: the Effect of Basic Body Awareness Therapy Versus Mixed Physical Activity as add-on Treatment. A Randomised Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 338
- 试验地点
- 2
- 主要终点
- Change in Harvard Trauma Questionnaire (HTQ)
研究概览
简要总结
The aim of this randomised controlled trial is to study two types of physical activities as add-on treatment, compared to treatment as usual for traumatised refugees. Hereby, the study will examine the evidence of an often-used treatment modality in a field where very little research yet has been conducted.
详细描述
About the clinic: The study will be carried out at the Competence Centre for Transcultural Psychiatry Denmark (CTP) (before January 2013 named Psychiatric Trauma Clinic for Refugees (PTF)). The clinic was established in 2008 and since 2009 the clinic has been carrying out randomised, controlled trials aiming to increase knowledge about the treatment effect of different types of treatment for traumatised refugees. The target group of the centre is traumatised refugees with PTSD, depression and anxiety. Patients are referred to CTP by general practitioners or psychiatrists. CTP treats approximately 200 patients/year.
The treatment is inter-disciplinary and consists of consultations with a medical doctor whereby pharmacological treatment according to best practice in the field is given, supplemented by cognitive behavioural therapy by a psychologist. Manuals are used for both the treatment given by the medical doctor as well as the psychologist. The total duration of treatment is 6 months.
Material and methods: 310 patients will be included from September 2013 to approximately May 2015. At the referral interview it is clarified whether the patient meets the inclusion or exclusion criteria. If the patient meets the inclusion criteria and gives her/his consent to participate, the patient is randomised to one of the three intervention groups:
A) Control group: receives treatment as usual (TAU) consisting of: 6 months of consultations and medical treatment according to best clinical practice by a medical doctor as well as manual-based Cognitive Behaviour Therapy by a psychologist.
B) Basic Body Awareness Therapy (BBAT): TAU + BBAT.
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
- •Patients referred to treatment for PTSD at Competence Centre for Transcultural Psychiatry from September 2013 to May
- •Adults (18 years or older)
- •Refugees or persons who have been brought in under family reunification
- •Symptoms of PTSD pursuant to the International Classification of Diseases (ICD-10) research criteria.
- •Psychological trauma in the anamnesis. Trauma is typically imprisonment or detention with torture (according to the United Nations definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.
- •Assessed by a doctor to be motivated for treatment
- •Informed consent.
排除标准
- •Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F30.9). Patients are excluded only if the psychotic-like experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression.
- •Current abuser of drugs and alcohol (F1x.24-F1x.26).
- •In need of admission to psychiatric hospital.
- •No informed consent.
- •Physical handicaps that make the person unable to participate in the physical activity.
- •Cardiac arrhythmia identified on the electrocardiogram taken before start of the treatment or symptoms of heart problems that are unclarified.
结局指标
主要结局
Change in Harvard Trauma Questionnaire (HTQ)
时间窗: Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).
次要结局
- Change in Visual Analogue Scale (VAS)(Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).)
- Change in Sheehan Disability Scale(Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).)
- Change in Dynamic Gait Index (DGI)(Assessing a potential change between baseline at the beginning of the treatment and after 6 months (at the end of treatment).)
- Change in Global assessment of function (GAF)(Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).)
- Change in Brief Pain Inventory Short Form (BPI)(Assessing a potential change between baseline at the beginning of the treatment and after 6 months (at the end of treatment).)
- Change in Hamilton depression + anxiety (HAM D+A)(Assessing a potential change between baseline at the beginning of the treatment and after 6 months (at the end of treatment).)
- Change in Senior Fitness Test (SFT)(Assessing a potential change between baseline at the beginning of the treatment and after 6 months (at the end of treatment).)
- Change in De Morton Mobility Index (DEMMI)(Assessing a potential change between baseline at the beginning of the treatment and after 6 months (at the end of treatment).)
- Change in Hopkins Symptom Check List (HSCL-25)(Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).)
- Change in World Health Organisation-5 (WHO5)(Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).)
- Change in Multidimensional Assessment of Interoceptive Awareness (MAIA)(Assessing a potential change between baseline at the beginning of the treatment and after 6 months (at the end of treatment).)