Early intervention versus treatment as usual for adolescents with first-episode psychosis: Protocol for the randomized OPUS YOUNG trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2026-03-01 Epub Date: 2026-02-05 DOI:10.1016/j.cct.2026.108253

Mathilde S. Madsen , Marianne Melau , Naja K. Andersen , Caroline Friis Nielsen , Natascha Larsen , Thomas Lind Andersen , Merete Nordentoft , Jens Richardt M. Jepsen , Anne A.E. Thorup , Pia Jeppesen , Birgitte Fagerlund , Martin Køster Rimvall , Patrick McGorry , Swaran Singh , Ditte Lammers Vernal , Lene Halling Hastrup , Lis Raabæk Olsen , Jacob Rydkjær , Christoph U. Correll , Robin Christensen , Anne Katrine Pagsberg

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引用次数: 0

Abstract

Background

The prognosis for early onset psychosis (EOP) is poor for a broad range of outcomes. Early intervention services (EIS) have proven beneficial for adult-onset first-episode psychosis, but no randomized trials have investigated EIS in samples of patients aged <18 years. We will examine benefits and harms of a new integrated intervention OPUS YOUNG for EOP. The primary objective is to compare the effect of the OPUS YOUNG intervention versus treatment as usual (TAU) on change in social functioning at end-of-treatment after two years.

Methods

This investigator-initiated, single-center, pragmatic randomized clinical trial with blinded outcome assessment takes place in child- and adolescent mental health services in Copenhagen, Denmark. We randomize 290 participants aged 12 to 17 years with first-onset psychosis in a 1:1 ratio to a two-year intervention with OPUS YOUNG versus TAU. The OPUS YOUNG manual builds on the Danish evidence-based intervention for young adults (OPUS) adjusted to meet the specific needs of youths. The primary outcome is social functioning (Personal and Social Performance Scale [PSP] total score). Key secondary outcomes include measures of psychotic, negative, and disorganized symptom dimensions, client satisfaction, and health-related quality of life. Analyses will follow the intention-to-treat principle and use mixed-effects repeated measures models.

Discussion

In a rigorous research design, we address the urgent need for evidence-based interventions integrating psychosocial and pharmacological treatments in an age-appropriate manualized program for EOP. The primary trial limitations are the risk of attrition during follow-up, and the inherent inability to mask for allocation in trials with psychosocial interventions.

Trial registration

ClinicalTrials.gov: NCT04916626, registered June 2021. Protocol and modifications is presented here:

https://classic.clinicaltrials.gov/ct2/show/NCT04916626

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早期干预与常规治疗对首发精神病青少年：随机OPUS YOUNG试验方案

背景：早发性精神病（EOP）的预后在很多方面都很差。早期干预服务（EIS）已被证明对成人发病的首发精神病有益，但没有随机试验调查EIS在老年患者样本中的作用。方法：这项研究者发起的、单中心的、实用的随机临床试验，采用盲法结果评估，在丹麦哥本哈根的儿童和青少年精神卫生服务中心进行。我们随机选取290名年龄在12 - 17 岁的首发精神病患者，以1:1的比例进行为期两年的OPUS YOUNG与TAU干预。OPUS YOUNG手册建立在丹麦针对年轻人的循证干预（OPUS）的基础上，对其进行了调整，以满足年轻人的具体需求。主要结果是社会功能（个人和社会表现量表[PSP]总分）。主要的次要结局包括精神病性、阴性和紊乱症状维度、病人满意度和健康相关生活质量的测量。分析将遵循意向治疗原则，并使用混合效应重复测量模型。讨论：在严格的研究设计中，我们解决了基于证据的干预措施的迫切需要，将社会心理和药物治疗结合在一个适合年龄的EOP手动计划中。试验的主要局限性是随访期间的减员风险，以及内在的无法掩盖在社会心理干预试验中的分配。试验注册：ClinicalTrials.gov: NCT04916626，注册于2021年6月。协议和修改如下：https://classic.Clinicaltrials: gov/ct2/show/NCT04916626。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.