EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Beast Cancer : a Faisability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- patients involvement
研究概览
简要总结
The study will consist in an adjustment/adaptation of the "standard EMDR protocol" for cancer disease, and most particulary for women who present a breast cancer and during adjuvant therapy. It will also test the faisability of the research, with a view to adjust the calendar and the ressources to put at disposal for a randomized control trial that follow. This study will also allow to test the need and acceptibility of this new psychotherapy for the patient, and to identify facilitators and obstacles : participation/rejection ratio, inclusion rythm, adhesion of the medical staff about the project
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Being a woman aged of 18 years or more
- •Having a primary invasive breast cancer
- •Having undergo a mastectomy for a primary invasive breast cancer
- •Being able to complete the questionnaires
- •Being informed of the study and having signed the informed consent
- •Being affiliated to a welfare system
排除标准
- •having contraindications to recieve EMDR psychotherapy (neurologic disorders, dissociatif states, oculomotor issues)
- •Having started adjuvant treatments following surgery
- •Having metastatic breast cancer
- •Presenting physical polypathologies
- •Having psychiatric antecedents (included anxiety and depressif disorders - assessed with M.I.N.I. (Sheehan and al., 1997)).
- •Having drug or alcohol addiction
- •Being placed under the safeguard of justice, guardianship or trusteeship
- •Being pregnant or breast-feeding
研究组 & 干预措施
Arms
Experimental: EMDR psychotherapy All the women will be in this arm and thus will receive the same intervention which is : 8 sessions (1 per week). The first session is an inclusion visit at Metz-Thionville Hospital, then 6 EMDR psychotherapy sessions and finally a last visit one month after for data recovery (questionnaire and semi-directive interview)
干预措施: EMDR psychotherapy (Behavioral)
结局指标
主要结局
patients involvement
时间窗: week 12
acceptability of the new psychotherapy
次要结局
- EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires(Week 12)
- adequacy of the intervention with the field(Week 12)