Data Sheet 1_Psychological assessments, allostatic load and gene expression analyses in a randomized controlled trial comparing meditation, yoga, and stress education.pdf

ObjectivesThe mind–body research field has explored a broad range of outcome measures, however, there has not been systematic investigation on these outcome measures and there is little knowledge on what outcome measures can capture the differences between different mind–body practices. Therefore, this three-arm randomized controlled trial examined the effects of meditation vs. yoga vs. an active control condition of stress education, with a large battery of outcome measures including psychosocial self-report variables, allostatic load biomarkers, and gene expression measures.
MethodsA total of 211 chronically stressed but otherwise healthy adults were randomized to 8-week one-on-one in-person interventions of meditation (N = 73), yoga (N = 68) or stress education (N = 70) interventions. Between-group differences in psychological outcome measurements, allostatic load biomarkers and genomic measures were compared at baseline (week 0), post-intervention (week 9), and at 26-week follow-up. Data were analyzed using a shared-baseline, two-way, repeated-measures ANOVA with unstructured within-person covariance over measurement timepoints. Treatment and time-specific effects were estimated using linear contrasts of adjusted means. False discovery rate correction was applied for multiple comparisons.
ResultsNone of the outcome measures had significant differences among the three treatment arms. Within each treatment arm, most psychological questionnaire measures showed significant improvements (corrected p < 0.05). IL-6 showed slight elevation (but still within normal range for healthy adults) at the post-intervention timepoint within the stress education arm (corrected p < 0.05) and at the follow-up timepoint within the meditation arm (corrected p < 0.05). High density lipoprotein (HDL) levels were increased within the yoga arm at the follow-up timepoint (corrected p < 0.05). Post-intervention score changes of the Perceived Stress Scale (PSS) correlated with blood pressure changes in the meditation arm, insulin level changes in the yoga arm, and changes of allostatic load index in the control arm, none of which survived correction for multiple comparisons.
ConclusionThis study did not find any significant between-group effects with any outcome measures. The null findings in this study might have been due to floor effects from the study sample of healthy adults.
Clinical trial registrationhttps://clinicalTrials.gov, identifier: NCT01308970.

研究目标

心身研究领域已对多种结局指标展开探索，但目前尚未针对这些指标开展系统性研究，且对于何种结局指标能够捕捉不同心身干预手段间的差异仍缺乏相关认知。因此，本项三臂随机对照试验对比了冥想、瑜伽与压力教育活性对照三种干预方式的效果，采用了涵盖社会心理自我报告变量、稳态负荷生物标志物及基因表达检测指标在内的多维度结局指标体系。

研究方法

共计211名存在慢性应激但其余身体状况健康的成年人被随机分配至8周一对一线下干预组，其中冥想组73例、瑜伽组68例、压力教育组70例。分别在基线（第0周）、干预后（第9周）及26周随访时，对比三组在心理结局指标、稳态负荷生物标志物及基因组检测指标上的组间差异。数据分析采用共享基线双向重复测量方差分析，以测量时间点下的个体内非结构化协方差进行建模；通过调整均值的线性对比估算干预措施与时间的特异性效应，并采用错误发现率校正处理多重比较问题。

研究结果

三组干预间未出现任何显著的组间结局指标差异。各组内部的多数心理问卷指标均呈现显著改善（校正后p<0.05）。白细胞介素-6（IL-6）在压力教育组的干预后时间点、冥想组的随访时间点均出现轻微升高（但仍处于健康成年人正常参考范围内），且差异具有统计学意义（校正后p<0.05）。瑜伽组在随访时的高密度脂蛋白（HDL）水平显著升高（校正后p<0.05）。感知压力量表（Perceived Stress Scale, PSS）的干预后得分变化与冥想组的血压变化、瑜伽组的胰岛素水平变化及对照组的稳态负荷指数变化均存在相关性，但上述相关性均未通过多重比较校正。

研究结论

本研究未在任何结局指标中发现显著的组间效应。本研究得到的阴性结果可能缘于研究样本为健康成年人所导致的地板效应。

临床试验注册

注册平台：https://clinicaltrials.gov，注册号：NCT01308970。