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HORYZONS 试验:一项随机对照试验的方案,旨在通过在线社交治疗来维持首发精神病服务的治疗效果。

HORYZONS trial: protocol for a randomised controlled trial of a moderated online social therapy to maintain treatment effects from first-episode psychosis services.

机构信息

Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Victoria, Australia.

Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.

出版信息

BMJ Open. 2019 Feb 19;9(2):e024104. doi: 10.1136/bmjopen-2018-024104.

DOI:10.1136/bmjopen-2018-024104
PMID:30782893
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6368148/
Abstract

INTRODUCTION

Specialised early intervention services have demonstrated improved outcomes in first-episode psychosis (FEP); however, clinical gains may not be sustained after patients are transferred to regular care. Moreover, many patients with FEP remain socially isolated with poor functional outcomes. To address this, our multidisciplinary team has developed a moderated online social media therapy (HORYZONS) designed to enhance social functioning and maintain clinical gains from specialist FEP services. HORYZONS merges: (1) peer-to-peer social networking; (2) tailored therapeutic interventions; (3) expert and peer-moderation; and (4) new models of psychological therapy (strengths and mindfulness-based interventions) targeting social functioning. The aim of this trial is to determine whether following 2 years of specialised support and 18-month online social media-based intervention (HORYZONS) is superior to 18 months of regular care.

METHODS AND ANALYSIS

This study is a single-blind randomised controlled trial. The treatment conditions include HORYZONS plus treatment as usual (TAU) or TAU alone. We recruited 170 young people with FEP, aged 16-27 years, in clinical remission and nearing discharge from Early Psychosis Prevention and Intervention Centre, Melbourne. The study includes four assessment time points, namely, baseline, 6-month, 12-month and 18-month follow-up. The study is due for completion in July 2018 and included a 40-month recruitment period and an 18-month treatment phase. The primary outcome is social functioning at 18 months. Secondary outcome measures include rate of hospital admissions, cost-effectiveness, vocational status, depression, social support, loneliness, self-esteem, self-efficacy, anxiety, psychological well-being, satisfaction with life, quality of life, positive and negative psychotic symptoms and substance use. Social functioning will be also assessed in real time through our Smartphone Ecological Momentary Assessment tool.

ETHICS AND DISSEMINATION

Melbourne Health Human Research Ethics Committee (2013.146) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website.

TRIAL REGISTRATION NUMBER

ACTRN12614000009617; Pre-results.

摘要

简介

专门的早期干预服务已证明在首次发作的精神病(FEP)中改善了结局;然而,在患者转至常规护理后,临床获益可能无法持续。此外,许多 FEP 患者仍处于社会隔离状态,功能结局较差。为了解决这一问题,我们的多学科团队开发了一种适度的在线社交媒体治疗(HORYZONS),旨在增强社交功能并维持来自专业 FEP 服务的临床获益。HORYZONS 结合了:(1)对等社交网络;(2)量身定制的治疗干预措施;(3)专家和同行的调节;以及(4)针对社交功能的新心理治疗模式(优势和正念干预)。本试验的目的是确定在接受 2 年的专业支持和 18 个月的在线社交媒体干预(HORYZONS)后是否优于 18 个月的常规护理。

方法和分析

这是一项单盲随机对照试验。治疗条件包括 HORYZONS 加常规治疗(TAU)或 TAU 单独治疗。我们招募了 170 名年龄在 16-27 岁、处于临床缓解期且即将从墨尔本早期精神病预防和干预中心出院的 FEP 年轻人。该研究包括四个评估时间点,即基线、6 个月、12 个月和 18 个月的随访。研究预计于 2018 年 7 月完成,包括 40 个月的招募期和 18 个月的治疗期。主要结局是 18 个月时的社交功能。次要结局指标包括住院率、成本效益、职业状况、抑郁、社会支持、孤独感、自尊、自我效能、焦虑、心理幸福感、生活满意度、生活质量、阳性和阴性精神病症状以及物质使用情况。我们的智能手机生态瞬时评估工具还将实时评估社交功能。

伦理和传播

墨尔本健康人类研究伦理委员会(2013.146)为本研究提供了伦理批准。研究结果将通过科学期刊和论坛提供,并通过社交媒体和 Orygen 网站向公众提供。

试验注册号

ACTRN12614000009617;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b61/6368148/7f44d39d8994/bmjopen-2018-024104f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b61/6368148/7f44d39d8994/bmjopen-2018-024104f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b61/6368148/7f44d39d8994/bmjopen-2018-024104f01.jpg

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