'MindRest: Mindful Network Dynamics Regulation Under Stress
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Difference in perceived stress between experimental and control group
研究概览
简要总结
This study aims to assess the effectiveness of Mindfulness Based Stress reduction to reduce perceived stress in a highly stressed student population, while concurrently investigating neural mechanisms of the intervention. The investigators will perform a randomized, wait-list controlled trial assessing clinical and neurocognitive outcomes as well as measures of daily life stress reactivity.
详细描述
Rationale: Prolonged stress exposure can put people at risk of developing stress-related symptomatology, such as burnout, sleeping disorders, depression and anxiety. Students reporting high levels of perceived stress are an at-risk population that could potentially benefit from a stress-reduction intervention. One approach to reduce stress is Mindfulness Based Stress Reduction (MBSR). Although proven effective, additional evidence is required on the effectiveness of MBSR in reducing stress-related symptoms in student sample pre-selected on high stress. Furthermore, the working mechanisms of MBSR are only marginally understood. This is problematic, because gaining better mechanistic insight on how MBSR works might lead (1) to basic scientific insights into stress and stress resilience and (2) clinically, to improve the provided interventions . In the light of preliminary psychological study results on MBSR the investigators hypothesize that MBSR will not only foster stress-reduction via cognitive control but also via experiential exposure. In accordance with this hypothesis and based on neurocognitive findings in basic stress research and previous mechanistic studies on MBSR, the investigators will assess whether MBSR indeed leads to improved stress-regulation by enhancing both cognitive and affective processing, which will be reflected in neural network configuration.
Objective
The main objective of this study is to assess the effectiveness of MBSR to reduce perceived stress in a highly stressed student population. Our main objective regarding working mechanisms of MBSR is to assess possible MBSR induced changes in large-scale neural network configuration and self-regulation of these networks. Additionally, this study aims to explore possible mediators and moderators of the treatment effect, both in terms of psychological traits, and neural patterns.
Study design: The investigators will perform a two-arm randomized, wait-list controlled trial with a randomisation ratio of 1:1. Participants will be randomised into a treatment and wait-list group after baseline Clinical Assessments (CA), Neurocognitive Assessments (NA), and Ecological Momentary Assessments (EMA). In the following two months the experimental group will participate in an MBSR training and the control group will wait for two months. Another CA and NA and EMA will take place 3 months after baseline. 6 months after baseline there will be a follow-up CA. Participants in the wait-list group will then receive an MBSR training, after which they will perform another CA.
Study population: The investigators will recruit 60 students per group ( total: 120) from Radboud University, Radboudumc, and HAN University of Applied Sciences in Arnhem and Nijmegen with high perceived stress. Participants above 18 years, able to give consent, who score ≥ 16 on the Perceived Stress Scale will be prompted to join our study. Participants will be excluded if they are receiving current specialised psychological or psychiatric treatment or medication, if they have insufficient comprehension of the Dutch language, if they have physical, cognitive, or intellectual impairments interfering with participation, such as deafness, blindness, or sensori-motor handicaps, if they were formerly or currently involved in MBCT or MBSR training, if they have a current drug or alcohol addiction, and if they have contraindications for MRI scanning (e.g., pacemaker, implanted metal parts, deep brain stimulation, claustrophobia, epilepsy, brain surgery, pregnancy).
Intervention: Participants in the treatment group will follow an MBSR training which consists of 8 weekly sessions lasting 2,5 hours; a silent day of approximately 6 hours; and daily home practice assignments of about 45 minutes. The control group will follow the training at the end of the study (7 months after baseline), therefore acting as a wait-list control group during the measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Baseline Measurements will occur before group assignments and therefore both participants and researchers are blinded to these measurements. Post-treatment measurements are de-blinded.
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
- •Able to give informed consent.
- •Perceived Stress Scale score ≥ 16.
排除标准
- •Current specialised psychological or psychiatric treatment or medication.
- •Insufficient comprehension of the Dutch language.
- •Physical, cognitive, or intellectual impairments interfering with participation, such as deafness, blindness, or sensori-motor handicaps.
- •Formerly/currently involved in MBCT or MBSR training.
- •Current drug or alcohol addiction.
- •Contraindications for MRI scanning (e.g., pacemaker, implanted metal parts, deep brain stimulation, claustrophobia, epilepsy, brain surgery, pregnancy).
研究组 & 干预措施
MBSR group
The MBSR group participants will receive an Mindfulness Based Stress Reduction training programme over 2 months.
干预措施: Mindfulness Based Stress Reduction (Behavioral)
Wait-list group
The wait-list control group participants will wait while the experimental group is participating in the Mindfulness Based Stress Reduction training. This group will follow the training at the end of the study (7 months after baseline), after all relevant measurements are concluded.
结局指标
主要结局
Difference in perceived stress between experimental and control group
时间窗: Change between baseline and 3 months
This is measured by the total score of the Perceived Stress Scale (PSS) 10-item questionnaire (range 0-40), which evaluates the degree to which an individual perceives their life as unpredictable, uncontrollable and overloading.
次要结局
- Depressive symptoms(At baseline, 3 months, 6 months)
- Childhood trauma(At baseline)
- Anxiety(At baseline, 3 months, 6 months)
- Allowing of emotions(At baseline, 3 months, 6 months)
- Self-compassion(At baseline, 3 months, 6 months)
- Alcohol use(At baseline, 3 months, 6 months)
- Repetitive negative thinking(At baseline, 3 months, 6 months)
- Cognitive reactivity(At baseline, 3 months, 6 months)
- Personality traits(At baseline, 3 months, 6 months)
- Controlled exogenous stress regulation(At baseline, 3 months)
- Mindfulness skills(Time Frame: At baseline, 3 months, 6 months)
- Blood Oxygen Level Dependent (BOLD) signal(At baseline, 3 months)
- Stress Resilience(At baseline, 3 months, 6 months)
- Positive mental health(At baseline, 3 months, 6 months)
- Automatic exogenous stress regulation(At baseline, 3 months)
- Automatic endogenous stress regulation(At baseline, 3 months)
- Controlled endogenous stress regulation(At baseline, 3 months)