本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(23)02791-5

摘要内容如下：

背景

心理健康问题在患有慢性疾病的儿童和年轻人中很常见，但许多有需要的人无法获得循证心理治疗。该研究的目的是评估综合心理健康治疗对患有癫痫的儿童和青少年的临床效果，癫痫是一种常见的慢性健康状况，已知与特别高的心理健康问题共发率相关。

方法

我们进行了一项平行组、多中心、开放标签、随机对照试验，参与者年龄为3-18岁，在英格兰和北爱尔兰的癫痫诊所就诊，符合常见精神健康障碍的诊断标准。参与者被随机分配（1:1；使用独立的网络系统），除了常规护理外，还接受癫痫儿童的心理健康干预（小鼠），或仅接受评估增强的常规护理（对照）。两组儿童和青少年都接受了全面的诊断性心理健康评估。MICE是一种模块化心理干预，旨在使用认知行为疗法和行为育儿策略等循证方法治疗儿童和青少年常见的心理健康问题。精神健康障碍的常规护理因地点而异，但通常包括转诊到适当的服务机构。参与者及其照顾者和临床医生没有对治疗分配进行屏蔽，但统计学家在分析之前被屏蔽。通过改良意向治疗分析的主要结果是随机分组后6个月的父母报告优势和困难问卷（SDQ）。该研究已完成并在ISRCTN（57823197）注册。

调查结果

1401名年轻人可能被认为符合纳入研究的条件。在排除531名年轻人后，对870名参与者进行了资格评估并完成了SDQ，480名照顾者同意在2019年5月20日至2022年1月31日期间纳入研究。2019年8月28日至2022年2月21日期间，334名参与者（小鼠组的平均年龄为10.5岁[SD 3.6]，对照组的平均年龄为10.3岁[SD 4.0]）被随机分配到根据年龄、原发性精神健康障碍、智力残疾诊断和自闭症谱系障碍（基线）平衡的最小化干预中。168名（50%）参与者为女性，166名（50%）为男性。166名参与者被随机分配到小鼠组，168名参与者被随机分配到对照组。6个月时，小鼠组148名参与者的平均SDQ困难为17.6（SD 6.3），对照组148名参与者的平均SDQ困难为19.6（SD 6.1）。小鼠的校正效应为-1.7（95%CI-2.8~-0.5；P=0.0040；科恩的D，0·3）。小鼠组中有14名（8%）患者经历了至少一次严重不良事件，而对照组中有24名（14%）。68%的严重不良事件（50例）因癫痫发作而入院。

解释

在改善患有癫痫和常见精神健康障碍的年轻人的情绪和行为困难症状方面，小鼠优于评估增强的常规护理。因此，该试验表明，精神健康合并症可以由各种临床医生有效和安全地治疗，在智力残疾和自闭症的背景下，利用跨年龄的综合干预。这项试验的证据表明，这种模式应该完全植入癫痫服务中，并作为年轻人其他慢性健康状况的模式。

英文原文如下：

Abstracts

BACKGROUND  Mental health difficulties are common in children and young people with chronic health conditions, but many of those in need do not access evidence-based psychological treatments. The study aim was to evaluate the clinical effectiveness of integrated mental health treatment for children and young people with epilepsy, a common chronic health condition known to be associated with a particularly high rate of co-occurring mental health difficulties.

METHODS  We conducted a parallel group, multicentre, open-label, randomised controlled trial of participants aged 3-18 years, attending epilepsy clinics across England and Northern Ireland who met diagnostic criteria for a common mental health disorder. Participants were randomised (1:1; using an independent web-based system) to receive the Mental Health Intervention for Children with Epilepsy (MICE) in addition to usual care, or assessment-enhanced usual care alone (control). Children and young people in both groups received a full diagnostic mental health assessment. MICE was a modular psychological intervention designed to treat common mental health conditions in children and young people using evidence-based approaches such as cognitive behaviour therapy and behavioural parenting strategies. Usual care for mental health disorders varied by site but typically included referral to appropriate services. Participants, along with their caregivers, and clinicians were not masked to treatment allocation but statisticians were masked until the point of analysis. The primary outcome, analysed by modified intention-to-treat, was the parent-report Strengths and Difficulties Questionnaire (SDQ) at 6 months post-randomisation. The study is complete and registered with ISRCTN (57823197).

FINDINGS  1401 young people were potentially deemed eligible for study inclusion. Following the exclusion of 531 young people, 870 participants were assessed for eligibility and completed the SDQ, and 480 caregivers provided consent for study inclusion between May 20, 2019, and Jan 31, 2022. Between Aug 28, 2019, and Feb 21, 2022, 334 participants (mean ages 10·5 years [SD 3·6] in the MICE group vs 10·3 [4·0] in control group at baseline) were randomly assigned to an intervention using minimisation balanced by age, primary mental health disorder, diagnosis of intellectual disability, and autistic spectrum disorder at baseline. 168 (50%) of the participants were female and 166 (50%) were male. 166 participants were randomly assigned to the MICE group and 168 were randomly assigned to the control group. At 6 months, the mean SDQ difficulties for the 148 participants in the MICE group was 17·6 (SD 6·3) and 19·6 (6·1) for the 148 participants in the control group. The adjusted effect of MICE was -1·7 (95% CI -2·8 to -0·5; p=0·0040; Cohen's d, 0·3). 14 (8%) patients in the MICE group experienced at least one serious adverse event compared with 24 (14%) in the control group. 68% percent of serious adverse events (50 events) were admission due to seizures.

INTERPRETATION  MICE was superior to assessment-enhanced usual care in improving symptoms of emotional and behavioural difficulties in young people with epilepsy and common mental health disorders. The trial therefore shows that mental health comorbidities can be effectively and safely treated by a variety of clinicians, utilising an integrated intervention across ages and in the context of intellectual disability and autism. The evidence from this trial suggests that such a model should be fully embedded in epilepsy services and serves as a model for other chronic health conditions in young people.

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