跳至主要内容
临床试验/NCT03664713
NCT03664713已完成不适用

Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Therapy Compared to Treatment As Usual (TAU) in Psychiatric Inpatients With Severe Mental Disorder and a History of Psychological Trauma

Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Change in clinical severity from baseline to post-treatment at 6 months and follow up at 12 months.

研究概览

简要总结

The study of psychological trauma has become increasingly important in the field of mental health research due to the strong negative impact it has on the course and prognosis of psychiatric pathologies. However, from a clinical point of view it is still an overlooked and even ignored component. There is scientific evidence that treating traumatic events at outpatient hospital services in patients with severe mental disorder improves both trauma-related symptoms and clinical symptoms. A first-line treatment for psychological trauma is Eye Movement Desensitization and Reprocessing (EMDR) therapy. This therapy is recommended by the World Health Organization for treating Post-Traumatic Stress Disorder and which has obtained promising first results in patients with severe mental disorder. This project proposes to test whether EMDR therapy in addition to standard treatment is more effective than standard treatment alone in psychiatric in-patients with severe mental disorder, in terms of reducing symptoms related to psychopathology and trauma, and in terms of improving functioning. Our first hypothesis is that EMDR will be more effective than standard treatment alone in reducing the severity of psychiatric symptoms. Our second hypothesis is that EMDR will be more effective than standard treatment alone in reducing the severity of trauma-related symptoms. Our third hypothesis is that EMDR will be more effective than standard treatment alone in improving functioning.

详细描述

Background

Severe mental disorders (SMD) are a group of diverse conditions which principally affect perception, cognition, emotion and behavioural control (Hyman et al. 2016). SMD has a significant health impact worldwide, both in economic terms as well as in mortality rate due to suicide or associated medical illnesses (Charlson et al. 2016), due to its high prevalence, frequent early age of onset, and its clinical course (usually chronic or with temporary improvements followed by relapse), and the cognitive deterioration of important mental capabilities.

The results of the different meta-analyses have shown that suffering adverse events in infancy significantly increases the risk of developing SMD in adult life (Bortolato et al., 2017; Palmier-Claus, Berry, Bucci, Mansell, & Varese, 2016). What is more, it is important to take into account that the presence of this comorbidity has important clinical implications, such as an increase in suicides, greater severity of symptoms, an increase in risky sexual behaviours, more hospital admissions, a worse disease course and a greater risk of being retraumatized (Rosenberg et al. 2007; Ford et al. 2007; Oquendo et al. 2005). However, at clinical level it is still an element which receives very little focus and may interfere in the correct evolution of the disease (Mauritz et al. 2013).

Two recently published studies in the severe psychiatric population have shown that the specific treatment of trauma improves in all cases the symptoms related to it in patients diagnoses with schizophrenia (van den Berg et al. 2015) and bipolar disorder (Novo et al. 2014), as well as showing an improvement in other clinical symptoms such as psychotic symptoms, paranoid ideation and hallucinations in the case of schizophrenia, and sub-syndromic symptoms in the case of bipolar disorder. In both studies, the intervention strategy used to treat traumatic events was EMDR (Eye Movement Desensitization and Reprocessing), a psychotherapeutic approach whose use in recent years has grown exponentially in clinical practice due to its great efficacy and safety, as well as being recommended by the World Health Organisation (WHO) and the American Psychiatric Association (APA) as a first line treatment for Post-traumatic Stress Disorder (PTSD) (Shapiro, 2014). It was developed at the beginning of the nineties by the North American psychologist Francine Shapiro to treat the consequences of psychological trauma. EMDR is an 8-phase psychological treatment composed of protocols and standardized procedures applicable to both adults and children. The eight phases (patient history, patient preparation, evaluation of the main aspects of the memory, desensitization of the traumatic memory, installation of the positive cognition, body scan, close and re-evaluation) and the protocol of the time line of past-present-future, allow a holistic evaluation of the image of the traumatic memory, and allow for the patient to be well-prepared before processing past events which underlie current pathology, current situations which cause perturbation, and challenges and possible future stimuli which might lead to the appearance of symptoms (Shapiro, 2014). The distinctive feature of this technique is the incorporation of bilateral stimulation, in the majority of cases through horizontal saccadic eye movements, into the combination of different theoretical and practical psychological orientations, in order to desensitize the suffering cause by traumatic memories and, as a consequence, achieve the reprocessing and the integration of these memories into the normalized biographic memories of the patient (Shapiro 2001). One of the main advantages of EMDR is that all protocols, both the standard and more specific ones, are standardized and scientifically validated both for clinical use and scientific scrutiny (Novo et al. 2016).

Evaluation & Diagnostic Protocol

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)

盲法说明

Evaluators will be blind to treatment. Participants cannot be blind to treatment due to the impossibility of creating a sham alternative to EMDR therapy, due to its use of bilateral stimulation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sub-acute or long-stay ward in-patients diagnosed with an affective or non-affective psychotic disorder, as per DSM-V criteria, who also present a history of traumatic events.

排除标准

  • abuse or dependence on substances in the previous 3 months (except nicotine), organic brain disease, presence of structured suicidal ideation and having received a trauma-focused therapy in the last 2 years.

结局指标

主要结局

Change in clinical severity from baseline to post-treatment at 6 months and follow up at 12 months.

时间窗: The stated improvement will be seen at 6 months and maintained at 12 months.

There will be a reduction in clinical severity of symptoms in the EMDR group as compared to the control group in terms of total score on the Brief Psychiatric Rating Scale (BPRS).

次要结局

  • Change in global clinical severity from baseline to post-treatment at 6 months and follow up at 12 months.(The stated improvement will be seen at 6 months and maintained at 12 months.)
  • Change in depression symptoms from baseline to post-treatment at 6 months and follow up at 12 months.(The stated improvement will be seen at 6 months and maintained at 12 months.)
  • Change in mania symptoms from baseline to post-treatment at 6 months and follow up at 12 months.(The stated improvement will be seen at 6 months and maintained at 12 months.)
  • Change in number of dissociative symptoms from baseline to post-treatment at 6 months and follow up at 12 months.(The stated improvement will be seen at 6 months and maintained at 12 months.)
  • Change in symptoms of schizophrenia from baseline to post-treatment at 6 months and follow up at 12 months.(The stated improvement will be seen at 6 months and maintained at 12 months.)
  • Change in number of patients with a Post-traumatic Stress Disorder (PTSD) diagnosis from baseline to post-treatment at 6 months and follow up at 12 months.(The stated improvement will be seen at 6 months and maintained at 12 months.)
  • Change in current impact of a traumatic event from baseline to post-treatment at 6 months and follow up at 12 months..(The stated improvement will be seen at 6 months and maintained at 12 months.)
  • Change in global functioning from baseline to post-treatment at 6 months and follow up at 12 months.(The stated improvement will be seen at 6 months and maintained at 12 months.)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Moreno Alcázar

PhD

Parc de Salut Mar

研究点 (2)

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