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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 ( IF 30.8 ) Pub Date : 2024-05-14 , DOI: 10.1016/s2215-0366(24)00101-9
June Brown , Kirsty James , Stephen Lisk , James Shearer , Sarah Byford , Paul Stallard , Jessica Deighton , David Saunders , Jynna Yarrum , Peter Fonagy , Timothy Weaver , Irene Sclare , Crispin Day , Claire Evans , Ben Carter

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. 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). 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. Our findings indicate that the DISCOVER intervention is modestly clinically effective and economically viable and could be a promising early intervention in schools. Given the importance of addressing mental health needs early in this adolescent population, additional research is warranted to explore this intervention. National Institute for Health and Care Research Health Technology Assessment Programme

中文翻译:


针对学龄青少年压力的简短认知行为治疗计划 (BESST) 的临床效果和成本效益:英国的一项整群随机对照试验



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 岁学生的简短易懂的压力研讨会计划的有效性。我们的目的是调查 DISCOVER 认知行为疗法 (CBT) 研讨会在 6 个月内与常规治疗相比针对 16-18 岁抑郁症状的临床效果和成本效益。我们在英国第六形式的学校或学院进行了一项多中心、整群随机对照试验,以评估简短的 CBT 研讨会 (DISCOVER) 与常规治疗相比的临床效果和成本效益。我们计划招募 60 所学校和 900 名青少年,通过自我推荐系统招募参与者。学校以 1:1 的比例随机分配,让参与者接受 DISCOVER 研讨会或照常治疗,按地点分层,并根据学校规模和多重剥夺指数进行平衡。参与者的年龄为 16-18 岁,参加了整个学年,寻求缓解压力的帮助,英语流利,能够提供书面知情同意书。结果评估员、高级卫生经济学家、高级统计学家和首席研究员均被蒙面。有生活经验的人参与了这项研究。主要结局是在 6 个月的随访中,在具有完整协变量数据的所有参与者的意向治疗人群中,通过情绪和情感问卷 (MFQ) 测量抑郁症状。该试验已在 ISRCTN 登记处注册 (ISRCTN90912799)。 111 所学校受邀参与这项研究,其中 7 所学校被视为不符合资格,47 所学校未表示同意。 2021年10月4日至2022年11月10日期间,对57所学校的933名学生进行了资格筛查,7名学生不符合纳入资格,26名学生未参加基线会议和评估,共有900名青少年参与了这项研究。 DISCOVER 组包括 443 名参与者(295 [67%] 女性和 136 [31%] 男性),常规治疗组包括 457 名参与者(346 [76%] 女性和 92 [20%] 男性)。 900 名参与者中有 468 名(52%)是白人,参与者的总体年龄为 17·2 岁(SD 0·6)。对意向治疗人群中的 873 名青少年 (97%) 进行了随访。主要意向治疗分析 (n=854) 发现 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)在 6 个月的随访中,表明 DISCOVER 组的临床改善。在每质量调整生命年阈值 20 000 至 30 000 英镑的情况下,DISCOVER 与常规治疗相比具有成本效益的概率为 61% 至 78%。 DISCOVER 组报告了 9 起不良事件(其中 2 起严重),常规治疗组报告了 14 起(其中 2 起严重)。我们的研究结果表明,DISCOVER 干预措施在临床上具有一定的有效性,在经济上也是可行的,并且可能是一种有前途的学校早期干预措施。鉴于尽早解决青少年群体心理健康需求的重要性,有必要进行更多研究来探索这种干预措施。 国家健康与护理研究所卫生技术评估计划
更新日期:2024-05-14
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