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面向未来的研究:一项整群随机对照试验,评估一项针对青少年抑郁症的基于学校的通用认知行为计划的有效性。

Future Proofing Study: a cluster randomised controlled trial evaluating the effectiveness of a universal school-based cognitive-behavioural programme for adolescent depression.

作者信息

Werner-Seidler Aliza, Mackinnon Andrew, Batterham Philip J, Calear Alison L, Larsen Mark E, Torok Michelle, O'Dea Bridianne, Maston Kate, Huckvale Kit, Fujimoto Hiroko, Johnston Lara, Brown Lyndsay, Batholomew Alexandra, Bal Debopriyo, Beames Joanne R, Skinner Susan Rachel, Boydell Katherine M, Schweizer Susanne, Lingam Raghu, Perry Yael, Hudson Jennifer L, Oei Ju Lee, Steinbeck Katharine, Teesson Maree, Venkatesh Svetha, Christensen Helen

机构信息

Black Dog Institute, UNSW Sydney, Sydney, New South Wales, Australia

School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.

出版信息

BMJ Ment Health. 2025 Mar 14;28(1):e301426. doi: 10.1136/bmjment-2024-301426.

DOI:10.1136/bmjment-2024-301426
PMID:
40086808
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11927416/
Abstract

BACKGROUND

Psychological prevention programmes delivered in schools may reduce symptoms of depression. However, high-quality, large-scale trials are lacking.

OBJECTIVE

The aim was to examine whether a digital cognitive-behavioural programme ('SPARX'), delivered at scale in schools, would reduce depressive symptoms 12 months later.

METHODS

A cluster randomised controlled trial with parallel arms (intervention; control) was conducted in Australian schools, between August 2019 and December 2022. Cluster randomisation occurred at the school level (1:1 allocation). Investigators were blind to group allocation, and outcomes were assessed at baseline, 6 weeks, 6 months (primary outcome only) and 12 months post baseline. The intervention was delivered via smartphone app. Schools were instructed to provide in-class time for intervention completion. The primary outcome was the difference in depressive symptom change from baseline to 12 months between the intervention and control group. Secondary outcomes were change in anxiety, psychological distress and insomnia.

FINDINGS

134 schools participated in this study, and baseline data were collected from n=6388 students (n=3266 intervention; n=3122 control). Intent-to-treat analyses showed no difference in depression change between groups from baseline to 12 months, (mean change difference= -0.05, z= -0.32, 95% CI: -0.36 to 0.23, p=0.75). There were no differences on secondary outcomes. Many schools did not provide in-class time for intervention completion, and engagement was low (22% completion rate).

CONCLUSIONS

Scaled delivery of a digital cognitive-behavioural programme did not reduce symptoms of depression, relative to a control group.

CLINICAL IMPLICATIONS

Given the variability in the engagement with and delivery of the digital universal cognitive-behavioural programme, caution is required prior to scaled delivery of SPARX in school contexts.

TRIAL REGISTRATION NUMBER

ACTRN12619000855123.

摘要

背景

在学校开展的心理预防项目可能会减轻抑郁症状。然而,缺乏高质量的大规模试验。

目的

旨在研究在学校大规模开展的数字认知行为项目(“SPARX”)在12个月后是否会减轻抑郁症状。

方法

2019年8月至2022年12月期间,在澳大利亚学校进行了一项双臂平行的整群随机对照试验(干预组;对照组)。整群随机化在学校层面进行(1:1分配)。研究人员对分组情况不知情,在基线、6周、6个月(仅主要结局)和基线后12个月评估结局。干预通过智能手机应用程序进行。学校被要求提供课堂时间以完成干预。主要结局是干预组和对照组从基线到12个月抑郁症状变化的差异。次要结局是焦虑、心理困扰和失眠的变化。

结果

134所学校参与了本研究,从n = 6388名学生中收集了基线数据(n = 3266名干预组;n = 3122名对照组)。意向性分析显示,从基线到12个月,两组之间的抑郁变化无差异(平均变化差异 = -0.05,z = -0.32,95%CI:-0.36至0.23,p = 0.75)。次要结局也无差异。许多学校没有提供课堂时间来完成干预,参与度较低(完成率22%)。

结论

相对于对照组,大规模开展数字认知行为项目并未减轻抑郁症状。

临床意义

鉴于数字通用认知行为项目的参与度和实施存在差异,在学校环境中大规模开展SPARX之前需要谨慎。

试验注册号

ACTRN12619000855123。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f8f/11927416/2b9f1bb8189b/bmjment-28-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f8f/11927416/2b9f1bb8189b/bmjment-28-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f8f/11927416/2b9f1bb8189b/bmjment-28-1-g001.jpg

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