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青少年神经性厌食症简短早期多家庭治疗(BEAM)试验:一项可行性随机对照试验方案

Brief early adolescent multi-family therapy (BEAM) trial for anorexia nervosa: a feasibility randomized controlled trial protocol.

作者信息

Baudinet Julian, Eisler Ivan, Simic Mima, Schmidt Ulrike

机构信息

Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, 16 De Crespigny Park, London, SE5 8AB, UK.

Maudsley Centre for Child and Adolescent Eating Disorders, South London and Maudsley NHS Foundation Trust, De Crespigny Park, Denmark Hill, London, SE5 8AZ, UK.

出版信息

J Eat Disord. 2021 Jun 16;9(1):71. doi: 10.1186/s40337-021-00426-4.

Abstract

INTRODUCTION

Multi-family therapy (MFT) is a recommended treatment for adolescent anorexia nervosa internationally. Despite recent significant advances in single-family therapy, the evidence base for MFT remains relatively small. Several individual and family factors have been associated with poorer outcomes in single-family therapy, many of which may be addressed or ameliorated by MFT if delivered early in treatment. This trial aims to determine the feasibility and acceptability of adding a five-day multi-family therapy group to the early stages of family therapy for anorexia nervosa. Secondary objectives are to explore effect size changes in key individual and family factors across treatment.

METHODS

This feasibility trial will use a randomised controlled design. Sixty adolescents (age 10-17 inclusive) with anorexia nervosa or atypical anorexia nervosa and their parents will be recruited from a community-based specialist eating disorder service in London, UK. Participants will be randomly allocated to receive six months of eating disorder focussed family therapy with a five-day MFT group (experimental group) or without (control group). Block randomisation will be conducted by the King's Clinical Trials Unit and researchers will be blind to participants' intervention allocation. Feasibility, acceptability and secondary outcomes measures will be collected at baseline, post-MFT, end of treatment, six-month and 12-month follow-up. Feasibility and acceptability will be assessed according to trial sign-up rates, retention, measure completion rates and satisfaction. Secondary outcomes include physical health improvements, changes in psychiatric symptoms, emotion regulation and reflective function capacity, expressed emotion, parental difficulties and therapeutic alliance. Descriptive data and exploration analysis of trends and effect sizes will be reported upon at trial completion.

DISCUSSION

The five-day MFT program developed for this study is novel, brief and more accessible than previous MFT models. The inclusion of a data collection point during treatment and follow-up will allow for an investigation of trends during and after treatment. This will allow exploration and comparison of future potential mediators and moderators of MFT and FT-AN outcomes and how these may differ between treatments.

TRIAL REGISTRATION

ISRCTN registry; ISRCTN93437752 , on 27 January 2021.

摘要

引言

多家庭治疗(MFT)是国际上推荐用于青少年神经性厌食症的一种治疗方法。尽管近期单家庭治疗取得了重大进展,但MFT的证据基础仍然相对较少。在单家庭治疗中,一些个体和家庭因素与较差的治疗结果相关,如果在治疗早期采用MFT,其中许多因素可能会得到解决或改善。本试验旨在确定在神经性厌食症家庭治疗的早期阶段增加一个为期五天的多家庭治疗组的可行性和可接受性。次要目标是探讨治疗过程中关键个体和家庭因素的效应大小变化。

方法

本可行性试验将采用随机对照设计。将从英国伦敦一家社区专业饮食失调服务机构招募60名患有神经性厌食症或非典型神经性厌食症的青少年(年龄在10至17岁之间)及其父母。参与者将被随机分配接受为期六个月的以饮食失调为重点的家庭治疗,并加入一个为期五天的MFT组(实验组)或不加入(对照组)。由国王临床试验单位进行区组随机化,研究人员将对参与者的干预分配情况不知情。将在基线、MFT后、治疗结束、六个月和十二个月随访时收集可行性、可接受性和次要结局指标。将根据试验报名率、留存率、测量完成率和满意度来评估可行性和可接受性。次要结局包括身体健康改善、精神症状变化、情绪调节和反思功能能力、表达性情绪、父母困难和治疗联盟。试验完成时将报告描述性数据以及对趋势和效应大小的探索性分析。

讨论

为本研究开发的为期五天的MFT计划是新颖的、简短的,并且比以前的MFT模型更容易获得。在治疗和随访期间纳入数据收集点将有助于调查治疗期间和治疗后的趋势。这将有助于探索和比较未来MFT和FT-AN结局的潜在中介因素和调节因素,以及这些因素在不同治疗方法之间可能存在的差异。

试验注册

ISRCTN注册库;ISRCTN93437752,于2021年l月27日注册。

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