A Mindfulness-based Intervention to Reduce Stress and Improve Prosocial Skills for Health-care Students : a Translational RCT Integrating Clinical, Neuroimaging and Biomedical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Work package 1 (WP1) - Perceived stress
研究概览
简要总结
We aim to study the clinical immediate and long-term efficacy of a web-delivered MBCT-L protocol targeting bachelor and master health-care students in Geneva, as well as to study the correlations of clinical, neuroimaging and biomedical effects of such an intervention.
Primary objective: To evaluate the immediate and long-term effect of MBCT-L on reducing perceived stress and improving pro-social skills for health-care students, compared to a control group.
Secondary objective: To evaluate the immediate and long-term effect of MBCT-L on trait mindfulness, compassion, global psychological well-being, sleep quality, anxiety, depression, satisfaction in studies and resilience, to broaden the clinical understanding of the impact of such an intervention.
详细描述
This study is led jointly by Prof. C. Nemitz-Piguet, Dr F. Jermann, and Prof. S. Rudaz, who serve as co-principal investigators.
This study is funded by the Swiss National Science Foundation (Grant number: 32003B_205111 / 1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Eligibility criteria were applied to recruit second, third- or fourth-year health students in Geneva, Switzerland, who were at least 18 years old, had some interest in mindfulness, were available for the duration of the study, and agreed on refraining from regular mindfulness practice until allocated to the MBCT-L group.
排除标准
- •Students were excluded if they had a current depressive episode, post-traumatic stress disorder, psychotic disorder, or substance dependency as identified through the Mini international Neuropsychiatric Interview (MINI). All participants received oral and written information about the trial and signed the informed consent form prior to the beginning of the study.
研究组 & 干预措施
Clinical arm
In this arm, participants complete clinical questionnaires
干预措施: Mindfulness-based Cognitive Therapy for Life (MBCT-L) (Other)
Neurobiological arm
In this arm, participants complete either MRI and or blood sample
干预措施: Mindfulness-based Cognitive Therapy for Life (MBCT-L) (Other)
结局指标
主要结局
Work package 1 (WP1) - Perceived stress
时间窗: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Perceived stress as measured by the Perceived Stress Scale (PSS; score range: 0 -56; a higher score indicates a higher perceived stress level)
Work package 1 (WP1) - Prosocial skills
时间窗: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Prosocial skills as measured by the Prosocialness Scale for Adults (PBS; score range: 16-80; a higher score indicate a greater tendency towards prosocial behaviors).
Work package 2 (WP2) - Socio-affective Video Task with Resting State (SoVT-Rest)
时间窗: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the SOVT-Rest
Work package 2 (WP2) - Montreal Imaging Stress Task (MIST)
时间窗: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Cortico-limbic emotion regulation network reactivity to psychological stress as measured by functional MRI (fMRI) in response to the MIST
Work package 3 (WP3) - Metabolic
时间窗: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Metabolic constitutive profiles
Work package 3 (WP3) - Lipid
时间窗: T0: baseline T1: 3 months from T0 T2: 9 months from T0
Lipid signalling profiles
次要结局
- WP3 - Cortisol(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP3 - Oxytocine(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP3 - Stress and inflammatory markers(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP2 - Resting State neuroimaging data(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP2 - Grey matter volume and functional connectivity in cortico-limbic emotion regulation networks (sMRI)(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP1 - Trait mindfulness(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP1 - Compassion(T0: baseline T1: 3 months after T0 T2: 9 months after T0)
- WP1 - Psychological well-being(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP1 - Insomnia(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP1 - Anxiety and depression(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP1 - Satisfaction with studies(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
- WP1 - Resilience(T0: baseline T1: 3 months from T0 T2: 9 months from T0)
研究者
Camille Nemitz Piguet
MD, PhD, PD
University of Geneva, Switzerland