Single Center, Randomized, Comparative, Prospective Interventional Study Evaluating the Impact of Brief Psychotherapy by Narrative Exposure Therapy (NET) on the Reduction of Symptoms of Post Traumatic Stress Disorder in Refugee and Asylum Seeking Women in the Program SINDIANE in Marseille
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- PTSD symptoms measure by PCL5
研究概览
简要总结
Displaced people, like refugees or asylum seekers, have high rate of potentially traumatic events. PTSD is one of the most common psychiatric trouble in this population. It requires specialized support and psychosocial program. Narrative Exposure Therapy (NET), a german psychotherapy, was developed in the 2000 to specifically treat psycho-trauma in this population. It is brief, effective on complex trauma and can be delivered by trained non-caregivers. All published randomized studies have conclued that NET is effetive, but there are still insifficient numbers to make recomendations. To our knowledge, NET has never been tested in France. In Marseille, SINDIANE is a community support and program for refugees and asylum seekers. Many workshops led by peer workers are offered to increase empowerment of beneficiaries and hel them to recover. The development of a NET workshop would make it possible to combine community support and specific and validated psychotherapy. Through this study, the investigators hypothesize that tratment of PTSD with NET in the community-based SINDIANE program decrease symptoms of PTSD.
详细描述
Methods and design Forty-six participants with a diagnosis of PTSD disorder within the SINDIANE program will be recruited. A prospective single-blind randomized clinical trial will be conducted comparing two groups, one participant in the classic SINDIANE program and one being treated in addition by NET workshp. The evaluations will be done at the baseline, after the intervention and at three and six months follow-up. IN addition, the qualitative and participatory research method called photovoice will be used to better understand the experiences of participants who recieve NETtroughout their recovery.
The primary objective is the assessment of the symptom intensity score (PCL-5) of posttraumatic stress disorder (PTSD).
Secondary objectives are represented by:
- The assessment of the stability over time of the PTSD symptom intensity score at three months and six months (PCL-5).
- Assessment of the intensity of global psychiatric comorbidities (RHS-15)
- Evaluation of life indicators: ability to act, quality of life (GSE self-efficacy questionnaire).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman over 18
- •Refugee or asylum seeker (habing applied to OFFPRA or with a residence permit)
- •Belonging to the SINDIANE community project
- •Having been exposed to at least one traumatic event (according to the DSM 5 definition validated by a doctor)
- •Having a PCL5 score greater than 23
- •Agreeing to participate in the study with an informed consent signed by the subject after explanations given by the investigating psychiatrist
- •Patient affiliated to a social security health care
- •Patient able to read and write arabic or french
排除标准
- •Be under the age of 18
- •Be included in another intervention research
- •Presence of severe mental retardation or dementia according to DSM5
- •Persons benefiting from special protection : under article L3212-1 and L3213-1 of the Public Health Code
- •Persons referred to in articles L1121-5 to L1121-8 of the CSP
- •Existence of a high suicide risk assessed by the R.U.D.
- •Patient subject to a compulsory care measure (Law n°2011-803 of july 5, 2011 relating to the rights and protection of persons subject to psychiatric care and the terms of care)
- •Patient refusing to sign the consent or unable to receive the information necessary to give informed consent
结局指标
主要结局
PTSD symptoms measure by PCL5
时间窗: 1 month post NET therapy
The PCL-5 is a self reported score. The higher the score, the greater intensity of the symptoms of PTSD. It is validated in english and french with goof psychometric characteristic. The total score of the questionnaire is 80. The scale varies per question from 0 to 4: 0 = Not at all 1. = A little bit 2. = Moderately 3. = Quite a bit 4. = Extremely If the patient gets a 0, it means that he/she does not have this symptom of post-traumatic stress. On the contrary, the more the score increases and tends towards 4, the more the symptom will be present in the patient.
次要结局
- Psychiatric comorbidity intensity score RHS15(before the intervention, 1 month post therapy, 3 months and 6 months)
- Evolution of PCL5 score(3 months and 6 months)
- EvExperience indicators intensity score (GSE)(before the intervention, 1 month post therapy, 3 months and 6 months)