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社交康复疗法联合早期干预服务以促进首发精神病患者的社交康复(SUPEREDEN3):一项单盲随机对照试验

Social recovery therapy in combination with early intervention services for enhancement of social recovery in patients with first-episode psychosis (SUPEREDEN3): a single-blind, randomised controlled trial.

作者信息

Fowler David, Hodgekins Jo, French Paul, Marshall Max, Freemantle Nick, McCrone Paul, Everard Linda, Lavis Anna, Jones Peter B, Amos Tim, Singh Swaran, Sharma Vimal, Birchwood Max

机构信息

Psychology Department, University of Sussex, Brighton, UK.

Norwich Medical School, University of East Anglia, Norwich, UK.

出版信息

Lancet Psychiatry. 2018 Jan;5(1):41-50. doi: 10.1016/S2215-0366(17)30476-5. Epub 2017 Dec 11.

DOI:10.1016/S2215-0366(17)30476-5
PMID:29242000
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5818038/
Abstract

BACKGROUND

Provision of early intervention services has increased the rate of social recovery in patients with first-episode psychosis; however, many individuals have continuing severe and persistent problems with social functioning. We aimed to assess the efficacy of early intervention services augmented with social recovery therapy in patients with first-episode psychosis. The primary hypothesis was that social recovery therapy plus early intervention services would lead to improvements in social recovery.

METHODS

We did this single-blind, phase 2, randomised controlled trial (SUPEREDEN3) at four specialist early intervention services in the UK. We included participants who were aged 16-35 years, had non-affective psychosis, had been clients of early intervention services for 12-30 months, and had persistent and severe social disability, defined as engagement in less than 30 h per week of structured activity. Participants were randomly assigned (1:1), via computer-generated randomisation with permuted blocks (sizes of four to six), to receive social recovery therapy plus early intervention services or early intervention services alone. Randomisation was stratified by sex and recruitment centre (Norfolk, Birmingham, Lancashire, and Sussex). By necessity, participants were not masked to group allocation, but allocation was concealed from outcome assessors. The primary outcome was time spent in structured activity at 9 months, as measured by the Time Use Survey. Analysis was by intention to treat. This trial is registered with ISRCTN, number ISRCTN61621571.

FINDINGS

Between Oct 1, 2012, and June 20, 2014, we randomly assigned 155 participants to receive social recovery therapy plus early intervention services (n=76) or early intervention services alone (n=79); the intention-to-treat population comprised 154 patients. At 9 months, 143 (93%) participants had data for the primary outcome. Social recovery therapy plus early intervention services was associated with an increase in structured activity of 8·1 h (95% CI 2·5-13·6; p=0·0050) compared with early intervention services alone. No adverse events were deemed attributable to study therapy.

INTERPRETATION

Our findings show a clinically important benefit of enhanced social recovery on structured activity in patients with first-episode psychosis who received social recovery therapy plus early intervention services. Social recovery therapy might be useful in improving functional outcomes in people with first-episode psychosis, particularly in individuals not motivated to engage in existing psychosocial interventions targeting functioning, or who have comorbid difficulties preventing them from doing so.

FUNDING

National Institute for Health Research.

摘要

背景

提供早期干预服务提高了首发精神病患者的社会康复率;然而,许多患者在社会功能方面仍存在严重且持续的问题。我们旨在评估在首发精神病患者中,早期干预服务联合社会康复治疗的疗效。主要假设是社会康复治疗加早期干预服务将改善社会康复情况。

方法

我们在英国的四个专科早期干预服务机构开展了这项单盲、2期随机对照试验(SUPEREDEN3)。纳入年龄在16 - 35岁、患有非情感性精神病、接受早期干预服务12 - 30个月且存在持续性严重社会残疾(定义为每周参与结构化活动少于30小时)的参与者。参与者通过计算机生成的带有置换区组(大小为4至6)的随机化方法被随机分配(1:1),接受社会康复治疗加早期干预服务或仅接受早期干预服务。随机化按性别和招募中心(诺福克、伯明翰、兰开夏郡和苏塞克斯)进行分层。由于必要原因,参与者未对分组分配进行设盲,但结果评估者对分配情况不知情。主要结局是通过时间使用调查测量的9个月时参与结构化活动的时间。分析采用意向性分析。该试验已在国际标准随机对照试验编号注册库(ISRCTN)注册,编号为ISRCTN61621571。

结果

在2012年10月1日至2014年6月20日期间,我们随机分配155名参与者接受社会康复治疗加早期干预服务(n = 76)或仅接受早期干预服务(n = 79);意向性分析人群包括154名患者。在9个月时,143名(93%)参与者有主要结局数据。与仅接受早期干预服务相比,社会康复治疗加早期干预服务使结构化活动时间增加了8.1小时(95%置信区间2. — 13.6;p = 0.0050)。未发现不良事件可归因于研究治疗。

解读

我们的研究结果表明,对于接受社会康复治疗加早期干预服务的首发精神病患者,强化社会康复对结构化活动具有临床重要益处。社会康复治疗可能有助于改善首发精神病患者的功能结局,特别是对于那些没有动力参与现有针对功能的心理社会干预措施,或因共病困难而无法参与的个体。

资助

英国国家卫生研究院。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a232/5818038/aed22baa66a3/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a232/5818038/aed22baa66a3/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a232/5818038/aed22baa66a3/gr1.jpg

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