Efficiency of the Use of Benevolent Memories in the EMDR Protocol in Complex Psychotrauma (Benevolence Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Effectiveness of the combination of SB and / or PMS with EMDR technique on reducing the disturbance experienced by patients with complex psychotrauma.
研究概览
简要总结
This study wants to demonstrate the effectiveness of combining a positive memory with "recommended" therapy based on EMDR in reducing the disturbance that patients with complex psychotrauma may experience. The positive memory will be called "benevolent memory" (SB) or "less worse memory" (SMP).
详细描述
This is an interventional study, prospective, exploratory, comparative, randomized, controlled versus reference treatment protocol, open.
Patients will be seen 16 times for the purposes of the study. They will be hospitalized during therapy. Discharge from hospitalization occurs during follow-up depending on the patient's condition.
They will be evaluated over a period of 4 to 6 weeks between the start (Day 0 = Week 1) and the end of treatment (visit week 12). These visits will coincide with treatment sessions with the EMDR ± SB / SMP protocol, as part of the support of their complex psychotrauma. At the end of treatment, the patient will be evaluated during follow-up visits at Month 1, Month 3 and Month 6.
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
- 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
- •Patient suffering from a combination of a period of complex trauma and a disturbance triggered by situations in adulthood;
- •Having signed an informed consent form to participate in the study.
排除标准
- •Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- •Patient seeking legal benefit from participating in the study;
- •Patient previously treated with EMDR;
- •Patient unable to understand the information related to the study (linguistic, psychological, cognitive reason, etc.);
- •Untreated epileptic patient;
- •Patient with severe oculomotor disorders;
- •Patient in hypomanic phase;
- •Patient treated with high dose corticosteroids;
- •Patient with alcohol and / or drug misuse in the 7 days preceding inclusion;
- •Pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding;
- •Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- •Patient not beneficiary of a social security scheme.
结局指标
主要结局
Effectiveness of the combination of SB and / or PMS with EMDR technique on reducing the disturbance experienced by patients with complex psychotrauma.
时间窗: 6 months
Percentage of patients with a 50% reduction in the SUD score(44/5000 measured by the SUD scale ranging from 0 to 10) at the end of the 3rd "active" EMDR session compared to the pre-treatment score of the 1st "active" session
次要结局
- Disturbance felt(6 months)
- Level of dissociation(6 months)