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

0 PSYCHIATRY BMJ mental health Pub Date : 2024-08-29 DOI:10.1136/bmjment-2024-301192
Stephen Lisk, Kirsty James, James Shearer, Sarah Byford, Paul Stallard, Jessica Deighton, David Saunders, Jynna Yarrum, Peter Fonagy, Timothy Weaver, Irene Sclare, Crispin Day, Claire Evans, Ben Carter, June Brown
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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.

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中学简短教育研讨会试验(BESST):分组随机对照试验。对抑郁症状升高者进行二次分析。
背景介绍抑郁和焦虑在青少年中越来越普遍。中学简短教育研讨会试验调查了针对 16-18 岁六年级学生的简短自我转介压力研讨会计划的有效性:本研究对基线抑郁症状升高的参与者的结果进行了二次分析:这是一项英格兰范围内的多中心、分组随机对照试验,旨在评估简短认知行为疗法工作坊(DISCOVER)与常规治疗(TAU)(1:1)相比的临床效果和成本效益。主要结果是随访 6 个月时的抑郁症状(情绪和感觉问卷 (MFQ)),采用意向治疗 (ITT) 人群,并通过多层次线性回归估计组间调整后平均差 (aMD) 进行分析。从国民健康服务(NHS)和个人社会服务的角度,采用质量调整生命年(QALYs)对成本效益进行了探讨:2021 年 10 月 4 日至 2022 年 11 月 10 日期间,57 所学校的 900 名青少年参加了研究。有 314 名学生被确定为基线抑郁症状加重(MFQ>27)。在这一预设分组中,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),3个月时也有类似的下降(aMD=-4.00;95% CI -6.58,-1.42;Cohen's d=0.53;p=0.002),这表明DISCOVER治疗组具有适度的、有临床意义的效果。我们发现每QALY的增量成本效益比为5255英镑,与TAU相比,DISCOVER具有成本效益的概率在89%至95%之间:DISCOVER对抑郁症状升高的患者临床有效且具有成本效益。试验注册号:ISRCTN90912799。
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