Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Perceived stress reactivity
研究概览
简要总结
This study is a double-blinded randomized controlled trial with two arms, comparing a recorded mindfulness intervention to a control psycho-education audio. It is a monocentric study that will take place in Centre Hospitalier Universitaire Vaudois (CHUV), a primary teaching hospital in Lausanne, Switzerland.
Patients will be randomized 1:1 to the brief mindfulness intervention vs neutral audio intervention. The investigators involved in recruitment and testing will be blind to the intervention condition. A collaborator that is not involved in this study will prepare a coded randomized sequence of audio assignments, uploaded in Redcap. The audio will be played on a laptop or mp-player with a noise cancelling headset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •We plan to recruit adult female patients (>18 years old) suffering from fibromyalgia (FMS), with chronic pain (more than 6 months), willing and able to give informed consent. Specifically, patients must fulfil the criteria of the American College of Rheumatology (2010) by having the following combination of scores at the widespread pain index (WPI) and the severity score (SS) :
- •WPI score is ≥7 and the SS score is ≥ 5 OR
- •WPI score is comprised between 3 to 6 and the SS score ≥9
- •And no other condition explaining the painful syndrome
排除标准
- •Insufficient French language skills
- •Unstable psychiatric co-morbidity: major depression with current suicidal risk, unstable psychotic disorder, unstable psychotropic medication (stable=more than 3 month under the same dose).
- •Somatic co-morbidity that could interfere with physiological monitoring/stress tolerance: such as cardiac malformation, recent myocardial dysfunction, cardiac transplantation, or cardiac treatment (pacemaker, antiarrhythmic drugs, muscarinic receptor blockers, ACE inhibitors or any that would induce a modification in HR)
- •Contraindication to sensors positioning (local skin damage or allergies)
- •Substance use disorder (alcohol, drugs).
- •Refusal to listen to an audio recording of mindfulness
研究组 & 干预措施
Mindfulness
干预措施: Mindfulness (Behavioral)
Psycho-education
干预措施: Psycho-education (Behavioral)
结局指标
主要结局
Perceived stress reactivity
时间窗: Within 3 hours
The primary outcome is the variation of perceived stress level along the task. A 2-way repeated-measures ANOVA will be conducted to compare the stress reactivity of patients receiving the mindfulness intervention and the control intervention. Perceived stress will be measured using visual analog scales from 0 to 10, 0 meaning no stress perceived and 10 meaning the highest stress perceived.
次要结局
- Heart rate variability(Within 3 hours)
- Electrodermal activity(Within 3 hours)
- Blood catecholamine levels(Within 3 hours)
- Respiration rate(Within 3 hours)
- Cerebral activity(Within 3 hours)
- Salivary cortisol concentrations(Within 3 hours)
- Oxygen saturation(Within 3 hours)
研究者
Chantal Berna
Professor
University of Lausanne Hospitals