Clinical effectiveness and cost-effectiveness of a brief accessible cognitive behavioural therapy programme for stress in school-aged adolescents (BESST): a cluster randomised controlled trial in the UK

——原载《柳叶刀 – 精神病学》2024年第11卷第7期——

<The Lancet - Psychiatry> Volume 11, Issue 7, 2024

【摘要】背景：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岁青少年的简短易行压力研讨会计划的有效性。我们旨在研究DISCOVER认知行为疗法 (CBT) 研讨会在6个月内对16-18岁青少年抑郁症状的临床有效性和成本效益，并与常规治疗相比。方法：我们在英国设有六年级的学校或学院进行了一项多中心、集群随机对照试验，以评估简短CBT研讨会 (DISCOVER) 与常规治疗相比的临床有效性和成本效益。我们计划招募60所学校和900名青少年，使用自我推荐系统招募参与者。学校按1:1的比例随机分配参与者，让他们接受DISCOVER研讨会或常规治疗，按地点分层，并根据学校规模和多重剥夺指数进行平衡。参与者年龄在16-18岁之间，参加整个学年，寻求压力帮助，英语流利，能够提供书面知情同意书，即可纳入研究。结果评估员、高级卫生经济学家、高级统计师和首席研究员均不知情。有生活经验的人参与了这项研究。主要结果是在6个月的随访中，在所有具有完整协变量数据的意向治疗人群中，使用情绪和情感问卷 (MFQ) 测量抑郁症状。该试验已在ISRCTN注册中心注册（ISRCTN90912799）。结果：111所学校受邀参与研究，其中7所被认为不符合资格，47所学校未提供同意书。2021年10月4日至2022年11月10日期间，57所学校的933名学生接受了资格筛查，7名学生不符合纳入条件，26名学生未参加基线会议和评估，最终共有900名青少年参与了研究。DISCOVER组包括443名参与者（295名 [67%] 名女性和136名 [31%] 名男性），常规治疗组包括457名参与者（346名 [76%] 名女性和92名 [20%] 名男性）。900名参与者中有468名（52%）为白人，参与者的总体年龄为17.2岁（SD 0.6）。在意向治疗人群中，873名（97%）青少年接受了随访。主要意向治疗分析 (n=854) 发现，6个月随访中，MFQ的调整平均差异为–2.06（95% CI –3.35至–0.76；Cohen's d=–0.17；p=0.0019），表明DISCOVER组临床改善。与常规治疗相比，DISCOVER 具有成本效益的可能性在每质量调整生命年阈值20,000至30,000英镑的情况下为 61%至78%。DISCOVER组报告了9起不良事件（其中2起被归类为严重事件），常规治疗组报告了14 起不良事件（其中2起被归类为严重事件）。

[Summary] Background: Depression and anxiety are increasingly prevalent in adolescents. The Brief Educational Workshops in Secondary Schools Trial investigated the effectiveness of a brief accessible stress workshop programme for 16–18-year-olds. We aimed to investigate the clinical effectiveness and cost-effectiveness of the DISCOVER cognitive behavioural therapy (CBT) workshop on symptoms of depression in 16–18-year-olds at 6 months compared with treatment-as-usual. Methods: We conducted a multicentre, cluster randomised controlled trial in UK schools or colleges with sixth forms to evaluate clinical effectiveness and cost-effectiveness of a brief CBT workshop (DISCOVER) compared with treatment-as-usual. We planned to enrol 60 schools and 900 adolescents, using a self-referral system to recruit participants. Schools were randomised in a 1:1 ratio for participants to receive either the DISCOVER workshop or treatment-as-usual, stratified by site and balanced on school size and index of multiple deprivation. Participants were included if they were 16–18 years old, attending for the full school year, seeking help for stress, and fluent in English and able to provide written informed consent. The outcome assessors, senior health economist, senior statistician, and chief investigator were masked. People with lived experience were involved in the study. The primary outcome was depression symptoms measured with the Mood and Feelings Questionnaire (MFQ) at 6-month follow-up, in the intention-to-treat population of all participants with full covariate data. The trial was registered with the ISRCTN registry (ISRCTN90912799). Findings: 111 schools were invited to participate in the study, seven were deemed ineligible, and 47 did not provide consent. Between Oct 4, 2021, and Nov 10, 2022, 933 students at 57 schools were screened for eligibility, seven were not eligible for inclusion, and 26 did not attend the baseline meeting and assessment, resulting in 900 adolescents participating in the study. The DISCOVER group included 443 participants (295 [67%] female and 136 [31%] male) and the treatment-as-usual group included 457 participants (346 [76%] female and 92 [20%] male). 468 (52%) of the 900 participants were White, and the overall age of the participants was 17·2 years (SD 0·6). 873 (97%) adolescents were followed up in the intention-to-treat population. The primary intention-to-treat analysis (n=854) found an adjusted mean difference in MFQ of –2·06 (95% CI –3·35 to –0·76; Cohen's d=–0·17; p=0·0019) at the 6-month follow-up, indicating a clinical improvement in the DISCOVER group. The probability that DISCOVER is cost- effective compared with treatment-as-usual ranged from 61% to 78% at a £20 000 to £30 000 per quality-adjusted life-year threshold. Nine adverse events (two of which were classified as serious) were reported in the DISCOVER group and 14 (two of which were classified as serious) were reported in the treatment-as-usual group.

论文原文：June Brown, Kirsty James, Stephen Lisk, James Shearer, Sarah Byford, Paul Stallar (2024). Clinical effectiveness and cost-effectiveness of a brief accessible cognitive behavioural therapy programme for stress in school-aged adolescents (BESST): a cluster randomised controlled trial in the UK. The Lancet - Psychiatry. Volume 11, Issue 7, Pages: 504-515, July 2024.

https://doi.org/10.1016/S2215-0366(24)00101-9

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