Bilateral Brain Stimulation in Trauma Therapy: a Randomized Clinical Trial
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
- Impact of Events Test
研究概览
简要总结
Comparatively studied the effects of Eye Movement Desensitization and Reprocessing (EMDR) bilateral brain stimulation in trauma therapy.
A randomized, parallel, before-after, blind study was performed.
详细描述
Comparatively studied the effects of Eye Movement Desensitization and Reprocessing (EMDR) bilateral brain stimulation in trauma therapy.
A randomized, parallel, before-after, blind study was performed. Thirty nine subjects were randomly distributed to two groups: one session of EMDR psychotherapy standard and other with EMDR standard protocol without its typical brain bilateral stimulation. The results of the Beck scales for anxiety, depression and hopelessness and the impact of events test were compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
All participants was invited to one session of brief Psychotherapy with a new model.
To the outcome assessor was said to study if was significant difference between those data from two groups α e β.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for the study were to be a university student, over 18 years old, to have a complaint associated to a traumatic life event and to have accepted to participate of the study.
排除标准
- •Exclusion criteria were the existence of untreated psychiatric disorders and the hypothesis of worsening of the subject's status as the number of sessions in this study was restricted to once.
结局指标
主要结局
Impact of Events Test
时间窗: Before and immediately after the psychotherapy session, which has average of 1:30 hours.
Self-administered questionnaire to measure Impact of the traumatic event, which the patient have selected for this intervention
Beck scale for anxiety
时间窗: Before and immediately after the psychotherapy session, which has average of 1:30 hours.
Self-administered questionnaire to measure anxiety, in this case, when the patient are thinking about that specific traumatic event, which he or she selected for this intervention.
次要结局
- Change from baseline Beck scale for hopelessness at the final of session(Before and immediately after the conclusion of the session, which has average of 1:30 hours)
- Change from baseline Beck scale for depression at the final of session(Before and immediately after the conclusion of the session, which has average of 1:30 hours)
研究者
Maria Aparecida Junqueira Zampieri
Clinical Supervisor, Principal Investigator
Ciclo de Mutação