中学简短教育讲座试验（BESST）：一项整群随机对照试验。对抑郁症状升高者的二次分析。

Brief Educational Workshops in Secondary Schools Trial (BESST): a cluster randomised controlled trial. Secondary analysis in those with elevated symptoms of depression.

机构信息

Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK

King's Clinical Trials Unit, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

出版信息

BMJ Ment Health. 2024 Aug 29;27(1):e301192. doi: 10.1136/bmjment-2024-301192.

DOI:10.1136/bmjment-2024-301192

PMID:39209761

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11367360/

Abstract

BACKGROUND

Depression and anxiety are increasingly prevalent in adolescents. The Brief Educational Workshops in Secondary Schools Trial investigated the effectiveness of a brief self-referral stress workshop programme for sixth-form students aged 16-18 years old.

OBJECTIVE

This study conducted a secondary analysis on the outcomes of participants with elevated depressive symptoms at baseline.

METHODS

This is an England-wide, multicentre, cluster randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of a brief cognitive-behavioural therapy workshop (DISCOVER) compared with treatment-as-usual (TAU) (1:1). The primary outcome was depression symptoms (Mood and Feelings Questionnaire (MFQ)) at 6-month follow-up, using the intention-to-treat (ITT) population and analysed with a multilevel linear regression estimating a between-group adjusted mean difference (aMD). Cost-effectiveness, taking a National Health Service (NHS) and personal social services perspective, was explored using quality-adjusted life years (QALYs).

FINDINGS

Between 4 October 2021 and 10 November 2022, 900 adolescents at 57 schools were enrolled. 314 students were identified as having elevated symptoms of depression at baseline (>27 on MFQ). In this prespecified subgroup, the DISCOVER arm included 142 participants and TAU included 172. ITT analysis included 298 participants. Primary analysis at 6 months found aMD to be -3.88 (95% CI -6.48, -1.29; Cohen's d=-0.52; p=0.003), with a similar reduction at 3 months (aMD=-4.00; 95% CI -6.58, -1.42; Cohen's d=0.53; p=0.002), indicating a moderate, clinically meaningful effect in the DISCOVER arm. We found an incremental cost-effectiveness ratio of £5255 per QALY, with a probability of DISCOVER being cost-effective at between 89% and 95% compared with TAU.

CONCLUSIONS AND CLINICAL IMPLICATIONS

DISCOVER is clinically effective and cost-effective in those with elevated depressive symptoms. This intervention could be used as an early school-based intervention by the NHS.

TRIAL REGISTRATION NUMBER

ISRCTN90912799.

摘要

背景

抑郁和焦虑在青少年中越来越普遍。中学短期教育研讨会试验调查了为 16-18 岁的六年级学生提供的简短自我转介压力研讨会计划的有效性。

目的

本研究对基线时有升高的抑郁症状的参与者的结果进行了二次分析。

方法

这是一项英格兰范围内的、多中心的、集群随机对照试验，旨在评估一种简短的认知行为治疗研讨会 (DISCOVER) 与常规治疗 (TAU) 相比的临床有效性和成本效益 (1:1)。主要结果是 6 个月随访时的抑郁症状（情绪和感觉问卷 (MFQ)），采用意向治疗（ITT）人群进行分析，并使用多层线性回归估计组间调整后平均差异（aMD）。从国家卫生服务（NHS）和个人社会服务的角度探讨了成本效益，使用了质量调整生命年（QALYs）。

结果

在 2021 年 10 月 4 日至 2022 年 11 月 10 日期间，有 57 所学校的 900 名青少年入组。在基线时（MFQ>27）有 314 名学生被确定为有升高的抑郁症状。在这个预先指定的亚组中，DISCOVER 组包括 142 名参与者，TAU 组包括 172 名参与者。ITT 分析包括 298 名参与者。6 个月时的主要分析发现 aMD 为-3.88（95%CI-6.48，-1.29；Cohen's d=-0.52；p=0.003），在 3 个月时也有类似的减少（aMD=-4.00；95%CI-6.58，-1.42；Cohen's d=0.53；p=0.002），表明 DISCOVER 组的疗效为中度，具有临床意义。我们发现增量成本效益比为每 QALY 5255 英镑，与 TAU 相比，DISCOVER 的成本效益在 89%至 95%之间。