Psychological and Neurobiological Impact of a Retreat Based on Mindfulness and Compassion for Stress Reduction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Epigenetic changes
研究概览
简要总结
The study is aimed at comparing the differential effects of two widely used standardized meditation programs: Mindfulness-Based Stress Reduction (MBSR) and Compassion Cultivation Training (CCT) delivered in a retreat format with a cross-over design in a general population sample of healthy adults.
详细描述
The main objective of the study is to evaluate the effects of two mindfulness-based intensive interventions: Mindfulness-Based Stress Reduction (MBSR) training or Compassion Cultivation Training (CCT), on psychological, physiological and epigenetic changes in a population of health volunteer adults. During a 7-day retreat participants will be randomised to two study arms: group 1 and 2, beginning either with a 3-day MBSR training or a 3-day CCT training. On the 4th day they will cross-over to the opposite intervention.
To address this goal, the effects will be measured by self-report questionnaires belonging to different domains (mindfulness, compassion, well-being, psychological distress, and psychological functioning), psychophysiological measures (EEG resting state, Diurnal cortisol slope, EKG and respiration patterns), epigenetic changes (DNA methylation biomarkers) and an objective stress task (Arithmetic Stress Test). Psychobiological outcome measures will be collected from both groups on day 1 (pre-intervention), on day 4 (post intervention and before beginning of the second intervention). The third assessment will be conducted on day 7 for both groups (post-second intervention). A 6-month follow-up assessment will be carried in both groups only for psychological questionnaires.
Data analysis will include change scores in psychological outcome measures as well as DNA methylation (by EPIC arrays) and gene expression (RNA-seq) measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
MBSR and CCT instructors will be blind to the study hypotheses. Investigators collecting, analyzing data and assessing outcomes will be blind to the group assignment.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult participants.
排除标准
- •Current or past self-reported diagnosable serious or disabling mental disorder (in particular, PTSD, major depression, psychotic disorders, and/or Use of alcohol or drugs disorders).
- •Presenting current health conditions that might affect the immune system (i.e. autoimmune disease, chronic severe infections, HIV, cancer) or past history of the same (less than 5 years from total recovery).
- •Presenting current habits that might affect the immune system (i.e. smoking, alcoholism, substance abuse).
- •Being under medical treatment that might affect the immune system response and inflammatory processes (i.e. corticoids).
- •Travelling from a different time zone/long-travel times that might affect the immune system.
结局指标
主要结局
Epigenetic changes
时间窗: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
Blood samples: 20 ml collected in the standard tubes used in clinical haematology that contain EDTA as an anticoagulant. From this biological material, DNA and RNA will be extracted according to the standard molecular biology procedures, in order to subsequently measure DNA methylation (by EPIC arrays) and gene expression (RNA-seq), respectively.
Change in Psychological distress
时间窗: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
Depression Anxiety Stress Scales (DASS-21), (Lovibond and Lovibond, 1995). The DASS-21 is a 21-item scale containing 3 subscales (Anxiety, Depression and Stress), with 7 items for each subscale. Participants are asked to rate each item using 4-point Likert scale (0=Not applicable to me; 3=Very applicable to me). Higher scores correspond to higher levels of severity of anxiety, stress, and depression.
Change in Stress Reactivity
时间窗: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
Mathematical Stress Test: a standardized laboratory stress induction procedure (Kirshbaum et al., 1992). Individuals are asked to repeatedly subtract a given 2-digit number from a 4-digit number. Time is limited to 3 minutes and participants are told that this is a mental speed task and their performance will be evaluated. Stress levels will be evaluated with an affective adjective checklist (PANAS scales).
Change in Resting State Activity
时间窗: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
EEG resting state (alternating open and closed eyes). EEG resting state will be recorded with four 64-channel EEG devices with laptop and eego EEG recording software. The sampling rate will be 1000 Hz and the reference to be used will be 7Z of the equidistant layout. The interventions will significantly change the EEG spectral profile of the resting state brain activity. We expect changes in the balance between Alpha (8-14 Hz) and Theta (4-8 Hz) frequency bands.
Change in Cortisol activity
时间窗: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program
Cortisol samples 1.5 - 2.0 ml will be collected in Salivette® cortisol saliva sample collection tubes (Sarstedt, Germany) that contain sterile cotton plugs for sample absorption. From this biological material, levels of the principal stress corticosteroid, the hormone cortisol, will be assessed in order to subsequently measure the Diurnal Cortisol Slope and cortisol levels at awakening and bedtime. Using saliva collection tubes, levels of the principal stress corticosteroid, the hormone cortisol, will be assessed in order to subsequently measure the Diurnal Cortisol Slope and cortisol levels at awakening and bedtime at three different moments of the retreat.
Change in Emotion regulation in retrieving autobiographical negative memories
时间窗: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
A 10-min guided test to retrieve one personally painful memory. Affect changes will be asssed before and after the task by using a checklist of affective adjectives (PANAS).
次要结局
- Change in Anxiety state and trait(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in Compassion - State self-compassion(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in current mood(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in Somatic Symptoms(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in Affect(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in Compassion - Fear of Compassion(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in Sleep difficulties(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in Mindfulness State(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in Mindfulness - Adverse Effects(Mid-intervention (T2: Day 4 in the 7-day program), post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in Psychological well-being - Satisfaction with life(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Change in Emotion Regulation(Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4))
- Program satisfaction(Mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program))
- Daily assessments of psychological functioning(Daily, at the end of the day, during the 7-day retreat)
研究者
Carmelo Vázquez
Full Professor of Psychopathology
Universidad Complutense de Madrid