A Multicenter Phase II Rater-blinded Randomized Controlled Trial (RCT) to Compare Effectiveness of Eye Movement Desensitization Reprocessing Therapy (EMDR) vs Treatment as Usual (TAU) in First Episode Psychosis and History of Trauma.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Reduction of the severity of trauma-related symptoms
研究概览
简要总结
The main objective of this project is to analyze whether EMDR therapy, as an adjuvant to usual treatment, is effective in reducing post-traumatic stress and psychotic/affective symptoms in patients with a FEP and comorbid psychological trauma associated with first hospital admission and / or previous stressful life event.
详细描述
Background: The experience of psychosis and hospitalization may be highly distressing. In fact, a significant proportion of FEP patients show posttraumatic stress symptoms during their recovery, which has been conceptualized as a posttraumatic postpsychotic syndrome (PPS). Moreover, the prevalence of childhood trauma in psychotic patients is four times higher than in general population. It is currently recognized the clinical implications of trauma in psychosis, as well as the need for treatment. Eye Movement Desensitization and Reprocessing (EMDR) therapy is a well stablished trauma treatment. EMDR is an eight- phase treatment protocol that includes bilateral stimulation to desensitize the discomfort caused by traumatic memories. Initial evidence suggests that EMDR is safe, well tolerated and beneficial in chronic patients with severe mental illness and comorbid psychological trauma.
Objectives: To assess if EMDR therapy leads to: 1) reduce post-traumatic stress symptoms; 2) reduce positive, negative and affective symptoms; 3) improve overall functioning; and 4) improve quality of life.
The hypothesis of this trial is that subjects of the EMDR group will experience an overall clinical improvement after therapy and will suffer from less admissions and relapses at 12 months of follow-up.
Design:
This is a multicenter phase II rater-blinded randomized controlled trial in which 80 FEP patients and psychological trauma will be randomly assigned to EMDR (n=40) or to TAU (n=40). Patients in the EMDR condition will receive up to 20 psychotherapeutic sessions of 60 minutes,
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
Clinical raters carrying out evaluations will be blind to the participants' research condition. Patients will not be blind to treatment as a sham alternative to EMDR therapy is impossible due to its use of bilateral stimulation.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥16 years old
- •presence of one or more traumatic events, causing symptoms associated with the trauma (Impact of Event Scale-Revised >0 and Subjective Units of Distress >5), but it is not necessary that traumatic events meet DSM-5 criteria for PTSD
- •psychotic symptoms/psychiatric hospitalization will be considered a traumatic event when the criteria for a trauma-related disorder or stress factors according to DSM-V (Post-Traumatic Stress Disorder, Acute Stress Disorder, and Other Trauma-related Disorder and unspecified stress factors) are also met
- •ability to read and write in Spanish.
排除标准
- •current suicidal risk
- •presence of organic brain diseases
- •have received trauma-focused therapy in the past 2 years.
研究组 & 干预措施
EMDR therapy
Patients in the psychotherapy intervention will receive up to 20 individual sessions of EMDR, weekly sessions, of 60 minutes each, using the standard EMDR therapy protocol developed by Shapiro to treat both current and past trauma-related symptom.
干预措施: Eye movement desensitization and reprocessing therapy (Behavioral)
EMDR therapy
Patients in the psychotherapy intervention will receive up to 20 individual sessions of EMDR, weekly sessions, of 60 minutes each, using the standard EMDR therapy protocol developed by Shapiro to treat both current and past trauma-related symptom.
干预措施: Treatment as usual (Drug)
Treatment as usual
Multidisciplinary approach that includes pharmacological treatment and psychological support.
干预措施: Treatment as usual (Drug)
结局指标
主要结局
Reduction of the severity of trauma-related symptoms
时间窗: Change from baseline to visits at 6 and 12 months
To measure severity and changes in trauma-related symptoms with the Impact of Event Scale - Revised. Items are rated on a 5-point Likert scale ranging from 0 and 4, yielding a total score ranging from 0 to 88.
次要结局
- Detection of dissociative symptoms(Change from baseline to visits at 6 and 12 months)
- Making a PTSD diagnosis(Change from baseline to visits at 6 and 12 months)
- Detection of Childhood life traumatic events(Childhood period. It is administered only during the baseline visit.)
- Detection of traumatic events in the last year(The last year. It is administered only during the baseline visit.)
- Reduction of positive psychotic symptoms(Change from baseline to visits at 6 and 12 months)
- Reduction in depressive symptoms(Change from baseline to visits at 6 and 12 months)
- Reduction of (hypo) manic symptoms(Change from baseline to visits at 6 and 12 months)
- Improvement of global functioning(Change from baseline to visits at 6 and 12 months)
- Improving of the quality of life associated with health(Change from baseline to visits at 6 and 12 months)
- Improving awareness of having a mental disorder and of their need for treatment(Change from baseline to visits at 6 and 12 months)
- Improving adherence to pharmacological treatment(Change from baseline to visits at 6 and 12 months)
- Reducing in the number of relapses(Change from baseline to visits at 6 and 12 months)