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ECHOMANTRA在线干预对成年神经性厌食症患者康复的支持效果:一项随机对照多中心试验的研究方案

Efficacy of the ECHOMANTRA online intervention to support recovery from anorexia nervosa in adult patients: study protocol of a randomized controlled multi-center trial.

作者信息

Quiles Yolanda, Ruiz Álvaro, León-Zarceño Eva, Manchón Javier, Neipp Marie-Carmen, Payá-López Sofía, Kovacheva Katina, Cardi Valentina

机构信息

Department of Behavioral Sciences and Health, Edificio Altamira, Miguel Hernández University, Avda de la Universidad S/N C. P., 03202, Elche, Spain.

Department of Health Psychology, Miguel Hernández University, Elche, Spain.

出版信息

J Eat Disord. 2025 Jan 13;13(1):7. doi: 10.1186/s40337-024-01166-x.

Abstract

BACKGROUND

Poor quality of life in adults with anorexia nervosa (AN) and persistent high rates of readmission highlight the necessity of developing interventions to optimize treatment outcomes. ECHOMANTRA is a novel online intervention based on interventions for carers (Experienced Carers Helping Others, ECHO) and patients (Maudsley Model of Anorexia Nervosa Treatment for Adults, MANTRA) with anorexia nervosa. The objective of this paper is to describe the study protocol of a randomized control trial (RCT) aimed at evaluating the efficacy of an adaptation of the ECHOMANTRA for adults AN inpatients and outpatients, and their carers, to be implemented as an add-on to treatment-as-usual (TAU).

METHODS

In a multi - center pilot randomized controlled trial (RCT), 148 adult AN patients, and their carers, will be randomized to receive treatment as usual (TAU) or TAU plus ECHOMANTRA. Assessments will take place at baseline (T0), post-intervention (2-month) (T1), 6-month follow-up (T2), and 12-month follow-up (T3). Primary outcomes will be eating disorder psychopathology and psychological well-being. For carers, outcome variables will include psychological well-being, accommodation and enabling behaviors, expressed emotion, illness burden, quality of life and care skills.

DISCUSSION

This study will provide evidence of the efficacy of this novel, online and protocolized intervention in facilitating the recovery of these patients.

TRIAL REGISTRATION

ISRCTN registry (Identifier: 80253157 https://doi.org/10.1186/ISRCTN80253157 ).

摘要

背景

神经性厌食症(AN)成人患者生活质量较差且再入院率持续居高不下,这凸显了开发优化治疗效果干预措施的必要性。ECHOMANTRA是一种基于针对神经性厌食症护理人员(经验丰富的护理人员帮助他人,ECHO)和患者(成人神经性厌食症治疗的莫兹利模型,MANTRA)的干预措施的新型在线干预。本文的目的是描述一项随机对照试验(RCT)的研究方案,该试验旨在评估ECHOMANTRA对成人AN住院患者和门诊患者及其护理人员的改编版本作为常规治疗(TAU)补充的疗效。

方法

在一项多中心试点随机对照试验(RCT)中,148名成年AN患者及其护理人员将被随机分配接受常规治疗(TAU)或TAU加ECHOMANTRA。评估将在基线(T0)、干预后(2个月)(T1)、6个月随访(T2)和12个月随访(T3)时进行。主要结局将是饮食失调的精神病理学和心理健康。对于护理人员,结局变量将包括心理健康、接纳和促成行为、表达性情绪、疾病负担、生活质量和护理技能。

讨论

本研究将提供证据,证明这种新型、在线且标准化的干预措施在促进这些患者康复方面的疗效。

试验注册

ISRCTN注册库(标识符:80253157 https://doi.org/10.1186/ISRCTN80253157

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be51/11731152/d2bd861cfd6b/40337_2024_1166_Fig1_HTML.jpg

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