The Effect of Motor Interference Therapy In Traumatic Memories: A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale (EVA)
研究概览
简要总结
The aim of the study is to compare the effect of motor interference therapy (TIM) to reduce the intensity of discomfort (distress) generated by a traumatic memory compared to a relaxation control maneuver, immediately after the intervention, a week, a month and six months after intervention.
详细描述
The investigators treated 10 patients with autobiographical traumatic memories using finger tapping tasks, (Motor Interference Therapy <TIM>)in a pilot study with amazing results and a solid size effect. The investigators decided to challenge the intervention using a control task (Jacobson´s progressive relaxation exercises) The hypothesis consists in achieving a 30% reduction of the distress, (measured with Visual Analogue Scale) by using TIM compared with the control task. Patients with traumatic memories will be enrolled in to one of two treatment modalities. The first group will receIve motor interference therapy and the second group will receive a control task (relaxation exercises). Both groups will be assessed using the Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R), the visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D), and a simple visual-analogue scale (VAS) immediately after, a week after, a month after and six months after the treatment for follow up.
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
- Double (Participant, Outcomes Assessor)
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
- •Patients older than 16 years
- •Spanish as a native language
- •Give written informed consent
- •having at least 1 traumatic memory causing distress
排除标准
- •Neurological or psychiatric disorders that affect the capacity of verbal comprehension and judgment, such as dementia, psychosis, mental retardation or other cognitive alteration that does not allow them to perform the tasks indicated in the TIM or SHAM
- •History of recent substance abuse
- •Patients with significant hearing loss or some other hearing impairment
研究组 & 干预措施
Motor Interference Therapy
Initial interview applying the Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R), the visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D), and a simple visual-analogue scale (VAS). After that, patients will listen to an audio track twice and follow the instructions. The first four minutes of the audio track instruct the subjects to tap their fingers in response to specific sounds. During the remaining ten minutes, the patients will be asked to recall a traumatic memory while simultaneously are tapping their fingers. Patients must complete at least 80% of the motor task in order to be included. We will reassess a week, a month and six months after the intervention, using all three scales.
干预措施: motor interference therapy (Other)
Relaxation Exercise
Initial interview applying the Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R), the visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D), and a simple visual-analogue scale (VAS). After that, patients will listen to an audio track twice and follow the instructions. The first four minutes of the audio track instruct the subjects in how to do the exercises. During the remaining 10 minutes will hear commands for performing progressive muscle tension-relaxation exercises while the patient evoked the traumatic memory. Patients must complete at least 80% of the motor task in order to be included. We will reassess a week, a month and six months after the intervention, using all three scales.
干预措施: Relaxation exercises (Other)
结局指标
主要结局
Change in Visual Analogue Scale (EVA)
时间窗: baseline, immediately, 1 week, 1 month, 6 months
measures the distress related to traumatic memories in 1-10
次要结局
- Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R)(baseline, 1 week, 1 month, 6 months)
- visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D)(baseline, 1 week, 1 month, 6 months)
研究者
Edgar Daniel Crail Melendez
M.SC.
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez