The Effect of Integrating Cross-sectoral Collaboration With the Municipality in Multidisciplinary Treatment of Trauma-affected Refugees; a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), interviewer administered 12-item version
研究概览
简要总结
INTRODUCTION Trauma-affected refugees are at high risk of developing mental health problems including post-traumatic stress disorder (PTSD) and depression. In addition to traumatic stress, refugees are furthermore subject to a range of post-migration stressors e.g. unemployment, poor finances and language difficulties. These stressors can moderate or exacerbate mental health outcomes in refugees.
Cross-sectoral collaboration and coordination of municipal social interventions and regional mental health services are currently limited.
The overall aim of this study is to investigate the effect of a psychosocial treatment with a focus on social stressors in an integrated cross-sectoral collaboration with the municipality for trauma-affected refugees
MATERIALS AND METHODS The study is being conducted at Competence Centre for Transcultural Psychiatry (CTP) in Denmark. Included in the study are refugees with post-traumatic stress disorder (PTSD), who are unemployed and attending a municipal job centre in one of the five collaborating municipalities. Approximately 200 patients will be included. The randomised controlled trial is comparing treatment as usual (TAU) comprising 10 sessions with a medical doctor (pharmacological treatment and psycho-education) and 16-21 sessions with a psychologist (manual-based cognitive behavioural therapy) with add-on of the social intervention. Overall, the intervention seeks to integrate working with social stressors alongside treatment for trauma-related mental health problems. This is done in two ways; by a cross-sectoral collaboration with municipality through collaborative meetings and by a systematic focus on social stressors during the treatment.
The primary outcome is functioning, measured by WHODAS 2.0 12 item version together with a variety of secondary outcomes measuring mental health symptoms, quality of life and degree of social stressors.
RESULTS The study is expected to bring forward new perspectives and knowledge on psychosocial treatment of trauma-affected refugees as well as cross-sectoral collaboration.
详细描述
INTRODUCTION Treatment-seeking trauma-affected refugees possess a complexity involving past trauma and ongoing social stressors, which challenges treatment of mental health problems. There is therefore a great need for developing holistic cross-sectoral interventions, where dealing with these complex challenges are integrated in treatment for trauma-related mental health problems. This research gap has led to the present research study.
The overall aim of this study is to examine a psychosocial intervention with an integrated cross-sectoral collaboration for refugees with post-traumatic stress disorder (PTSD) in a randomised controlled trial (RCT) supplemented by a qualitative study.
For the RCT the objectives are:
- To investigate the treatment effect of a psychosocial, cross-sectoral intervention on outcomes of functioning, quality of life and mental health symptoms compared to treatment as usual (TAU) at Competence Center for Transcultural Psychiatry (CTP).
- To study social stressors as a predictor of severity of mental health symptoms, quality of life and functioning at baseline.
- To examine predictors for positive outcomes of treatment including social stressors as a predictor.
Course of treatment and data collection will follow the SPIRIT statement
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
- Single (Outcomes Assessor)
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
- •Adults (18 years or older).
- •Refugees or persons who have been family reunified with a refugee.
- •PTSD pursuant to the ICD-10 research criteria.
- •Psychological trauma experienced outside Denmark in the anamnesis. Trauma is 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.
- •Home address in one of the five collaborating municipalities.
- •Unemployed and assigned to a jobcentre in a collaborating municipality.
- •Signed informed consent.
排除标准
- •Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression.
- •Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).
研究组 & 干预措施
Treatment as usual (TAU)
8-12 months of treatment
干预措施: Treatment as usual (TAU) (Behavioral)
Cross-sectoral social intervention
8-12 months of treatment
干预措施: Cross-sectoral psychosocial intervention (Behavioral)
Cross-sectoral social intervention
8-12 months of treatment
干预措施: Treatment as usual (TAU) (Behavioral)
结局指标
主要结局
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), interviewer administered 12-item version
时间窗: Change from baseline to end-of-treatment after approximately 10 months
Measure of health and disability across cultures. Scoring range: 0-48, lower scores reflect better outcome.
次要结局
- Hopkins Symptom Check List - 25 (HSCL-25)(Change from baseline to end-of-treatment after approximately 10 months)
- European Quality of Life (EQ-5D-5L)(Change from baseline to end-of-treatment after approximately 10 months)
- Global Assessment of Functioning - Functioning (GAF-F)(Change from baseline to end-of-treatment after approximately 10 months)
- Sheehan Disability Scale (SDS)(Change from baseline to end-of-treatment after approximately 10 months)
- Global Assessment of Functioning - Symptoms (GAF-S)(Change from baseline to end-of-treatment after approximately 10 months)
- The Harvard Trauma Questionnaire (HTQ) Part IV(Change from baseline to end-of-treatment after approximately 10 months)
- World Health Organisation - 5 Well-being Index (WHO-5)(Change from baseline to end-of-treatment after approximately 10 months)
- Post-migration Living Difficulties Check List (PMLD)(Change from baseline to end-of-treatment after approximately 10 months)
- Consumer Health Activation Index (CHAI)(Change from baseline to end-of-treatment after approximately 10 months)
研究者
Maja Bruhn Kristiansen
MD, Principal Investigator
Mental Health Services in the Capital Region, Denmark