Biostatistics Core, Centre for Addiction and Mental Health, Toronto, ON, Canada.
Center for Complex Interventions, Centre for Addiction and Mental Health, Toronto, ON, Canada.
Can J Psychiatry. 2023 Sep;68(9):639-648. doi: 10.1177/07067437231154993. Epub 2023 Feb 6.
This study aimed to provide a general overview of mental health randomized controlled trials (RCTs) and summarize the temporal trends in terms of the number of studies, median sample sizes, and median effect sizes using data collected from the Cochrane Database of Systematic Reviews (CDSR).
Using data collected from the CDSR, the temporal trends are compared in terms of the number of studies, median sample sizes, and median effect sizes between two broad categories of interventions: pharmacological RCT (ph-RCT) and non-pharmacological RCT (nph-RCT), and in conjunction with major mental disorder categories.
Chronologically, the number of mental health RCTs reported in publications has increased exponentially from 1955 to 2020. While ph-RCT comprised a majority of mental health RCTs in the earlier years, the proportion of nph-RCTs increased more quickly over time and markedly exceeded ph-RCT after 2010. The median sample size for all 6,652 mental health RCTs was 61, with 61 for ph-RCT and 60 for nph-RCT. Over time, the median fluctuated but an increasing trend was observed over the past 60+ years. The median of the effect size, measured by Pearson's , for overall RCTs was 0.18, and nph-RCT (0.19) had a larger median effect size compared to ph-RCT (0.16). Over the years, the nph-RCT had a larger median effect size than the ph-RCT. Differences in the median effect sizes among the categories of mental disorders were also noted. Schizophrenia had the most RCTs, with a median Pearson's value of 0.17. Mood disorder had the second largest number of RCTs and a median Pearson's value of 0.15. Neurotic/stress-related mental disorder had the third largest number of RCTs with the highest median Pearson's being 0.23.
This study provides meaningful information and filled the knowledge gap in mental health RCTs.
本研究旨在提供一篇关于心理健康随机对照试验（RCT）的概述，并使用从 Cochrane 系统评价数据库（CDSR）中收集的数据，总结研究数量、中位数样本量和中位数效应大小的时间趋势。
使用从 CDSR 中收集的数据，根据两种广泛的干预类别（药理学 RCT（ph-RCT）和非药理学 RCT（nph-RCT））以及主要精神障碍类别，比较了研究数量、中位数样本量和中位数效应大小的时间趋势。
从 1955 年到 2020 年，发表的心理健康 RCT 数量呈指数级增长。虽然 ph-RCT 在早期占大多数心理健康 RCT，但 nph-RCT 的比例随着时间的推移增长更快，并且在 2010 年后明显超过了 ph-RCT。所有 6652 项心理健康 RCT 的中位数样本量为 61，ph-RCT 为 61，nph-RCT 为 60。随着时间的推移，中位数波动，但在过去 60 多年中观察到了上升趋势。总体 RCT 效应大小（以 Pearson's 衡量）的中位数为 0.18，nph-RCT（0.19）的中位数效应大小大于 ph-RCT（0.16）。多年来，nph-RCT 的中位数效应大小大于 ph-RCT。还注意到了精神障碍类别的中位数效应大小之间的差异。精神分裂症 RCT 数量最多，中位数 Pearson's 为 0.17。心境障碍 RCT 数量第二多，中位数 Pearson's 为 0.15。神经症/应激相关精神障碍 RCT 数量第三多，中位数 Pearson's 最高，为 0.23。
本研究提供了有意义的信息，并填补了心理健康 RCT 领域的知识空白。
