Gleeson John, Lederman Reeva, Herrman Helen, Koval Peter, Eleftheriadis Dina, Bendall Sarah, Cotton Sue M, Alvarez-Jimenez Mario
School of Psychology, Faculty of Health Sciences, Australian Catholic University, Fitzroy, Australia.
The Department of Computing and Information Systems, The University of Melbourne, Parkville, Australia.
Trials. 2017 Jan 17;18(1):27. doi: 10.1186/s13063-016-1775-5.
First-episode psychosis most often has its onset during late adolescence. In caring for the young person, families endure high levels of stress and depression. Meanwhile, the social networks of families often erode. Our group has previously shown that family cognitive behaviour therapy (CBT) leads to significantly improved perceived stress compared with specialist first-episode treatment as usual; however, there are well-known barriers to the dissemination of effective family interventions. To address this, we have developed a novel online intervention entitled 'Altitudes' that fully integrates purpose-built online social networking, expert and peer moderation, and evidence-based psychoeducation within a single application. The primary aim of this trial is to evaluate the effectiveness of Altitudes in reducing stress in carers over a 6-month period.
METHODS/DESIGN: We describe here a single-blinded cluster randomised controlled trial (cRCT) with permutated blocks. The clusters comprise individual families. The two treatment conditions include Altitudes plus Specialist Treatment as Usual (STAU) and STAU alone. Altitudes involves participation in our novel online programme whereas STAU comprises specialist family work at the Early Psychosis Prevention and Intervention Centre (EPPIC), Melbourne, Australia. We aim to recruit 160 family members of young, 15-27 year-old, patients registered for treatment for first-episode psychosis (FEP) at EPPIC. The design includes two assessment time points, namely, baseline and 6-month follow-up. The study is due for completion within 2 years including an 18-month recruitment period and a 6-month treatment phase. The primary outcome is carers' perceived stress at 6 months. Secondary outcome measures include a biomarker of stress, depressive symptoms, worry, substance use, loneliness, social support, satisfaction with life, and a range of measures that tap into coping resources. We seek to gain a dynamic picture of carer stress through our Smartphone Ecological Momentary Assessment (SEMA) tool.
This is the first randomised controlled trial designed to evaluate an online intervention for carers of young people recovering from FEP. It has the potential to produce evidence in support of a highly novel, accessible, and cost-effective intervention to reduce stress in carers who are providing support to young people at a critical phase in their recovery from psychosis.
Australian New Zealand Clinical Trial Registry, identifier: ACTRN12616000968471 . Retrospectively registered on 22 July 2016.
首发精神病最常在青春期后期发病。在照顾年轻人的过程中，家庭承受着高水平的压力和抑郁。与此同时，家庭的社交网络往往会受到侵蚀。我们的团队此前已经表明，与常规的专科首发治疗相比，家庭认知行为疗法（CBT）能显著改善感知到的压力；然而，有效的家庭干预措施在传播方面存在众所周知的障碍。为了解决这个问题，我们开发了一种名为“Altitudes”的新型在线干预措施，该措施在一个应用程序中全面整合了专门构建的在线社交网络、专家和同伴管理以及循证心理教育。这项试验的主要目的是评估“Altitudes”在6个月内减轻照顾者压力方面的有效性。
方法/设计：我们在此描述一项采用置换区组的单盲整群随机对照试验（cRCT）。整群包括各个家庭。两种治疗条件包括“Altitudes”加常规专科治疗（STAU）以及仅接受STAU。“Altitudes”包括参与我们的新型在线项目，而STAU包括在澳大利亚墨尔本早期精神病预防与干预中心（EPPIC）开展的专科家庭工作。我们的目标是招募160名年龄在15至27岁之间、在EPPIC登记接受首发精神病（FEP）治疗的年轻患者的家庭成员。该设计包括两个评估时间点，即基线和6个月随访。该研究预计在2年内完成，包括18个月的招募期和6个月的治疗阶段。主要结局是6个月时照顾者感知到的压力。次要结局指标包括压力的生物标志物、抑郁症状、担忧、物质使用、孤独感、社会支持、生活满意度以及一系列涉及应对资源的指标。我们试图通过我们的智能手机生态瞬时评估（SEMA）工具全面了解照顾者的压力情况。
这是第一项旨在评估针对从FEP康复的年轻人的照顾者的在线干预措施的随机对照试验。它有可能提供证据支持一种高度新颖、易于获得且具有成本效益的干预措施，以减轻在年轻人从精神病康复的关键阶段为其提供支持的照顾者的压力。
澳大利亚新西兰临床试验注册中心，标识符：ACTRN12616000968471。于2016年7月22日追溯注册。
