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多中心随机对照试验比较多家庭治疗(MFT)和系统单家庭治疗(SFT)在青少年神经性厌食症患者中的应用:THERAFAMBEST 研究方案。

Multicenter randomized controlled trial on the comparison of multi-family therapy (MFT) and systemic single-family therapy (SFT) in young patients with anorexia nervosa: study protocol of the THERAFAMBEST study.

机构信息

Psychiatry Unit, Institut Mutualiste Montsouris, Paris, France.

CESP, INSERM, UMR 1018, University Paris-Sud, UVSQ, University Paris-Saclay, Villejuif, France.

出版信息

Trials. 2019 Apr 30;20(1):249. doi: 10.1186/s13063-019-3347-y.

DOI:10.1186/s13063-019-3347-y
PMID:31039797
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6492384/
Abstract

BACKGROUND

Anorexia nervosa (AN) is a serious psychiatric illness that begins most of the time during adolescence. An early and efficacious intervention is crucial to minimize the risk of the illness becoming chronic and to limit the occurrence of comorbidities. There is a global consensus on optimal treatment for adolescents suffering from AN: international guidelines recommend single-family therapy that involves the patient and his/her family. Several family therapy approaches have been developed to date. However, these approaches, which imply a direct questioning of intrafamilial dynamics, are not suitable for all patients and families, and the rates of dropout or poor response to treatment remain quite high. A modality of family therapy has been adapted to AN, known as multi-family therapy (MFT), which consists in bringing together several families whose children suffers from the same illness. Objectives of the present randomized clinical trial are to evaluate whether the implementation of MFT in a multi-disciplinary treatment program for adolescents with AN is at least as efficacious as the use of systemic single-family therapy (SFT), with respect to the evolution of body mass index and other clinical outcomes 12 and 18 months after the start of treatment. A cost-efficiency analysis will also be conducted.

METHODS

One hundred fifty patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups. Patients and their families will receive 10 sessions of therapy spread over 12 months. Body weight, eating disorder and other psychopathology-related symptoms, quality of family relationships, and family satisfaction with treatment will be evaluated during the treatment and at an 18 months follow-up. A cost-efficiency analysis will also be carried out.

DISCUSSION

We hypothesize that MFT is at least as efficacious as SFT, but at a lesser cost. The identification of possible preferential indications for each technique could help the improvement of therapeutic indications for adolescents suffering from AN and contribute to the earliness of intervention, which is associated with a better outcome.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT03350594 . Registered on 22 November 2017. IDRCB number 2016-A00818-43.

摘要

背景

神经性厌食症(AN)是一种严重的精神疾病,大多数情况下始于青春期。早期和有效的干预对于降低疾病慢性化的风险和减少合并症的发生至关重要。国际上对于治疗患有 AN 的青少年患者有一个共识:国际指南建议采用涉及患者及其家庭的单一家庭疗法。迄今为止,已经开发了几种家庭治疗方法。然而,这些方法涉及到对家庭内部动态的直接质疑,并不适合所有患者和家庭,而且治疗的辍学率或反应不佳率仍然相当高。已经对一种家庭治疗方法进行了调整,称为多家庭治疗(MFT),即将患有同种疾病的几个家庭聚集在一起。本随机临床试验的目的是评估在针对患有 AN 的青少年的多学科治疗计划中实施 MFT 是否至少与使用系统性单一家庭治疗(SFT)一样有效,在治疗开始 12 和 18 个月后,从身体质量指数和其他临床结果方面进行评估。还将进行成本效益分析。

方法

符合纳入标准的 150 名患者将被随机分配到两个治疗组之一。患者及其家人将在 12 个月内接受 10 次治疗。在治疗期间和 18 个月随访时,将评估体重、饮食障碍和其他与精神病理学相关的症状、家庭关系质量以及家庭对治疗的满意度。还将进行成本效益分析。

讨论

我们假设 MFT 至少与 SFT 一样有效,但成本更低。确定每种技术的可能优先适应症可以帮助改善患有 AN 的青少年的治疗适应症,并有助于尽早干预,这与更好的治疗结果相关。

试验注册

ClinicalTrials.gov,NCT03350594。于 2017 年 11 月 22 日注册。IDRCB 编号 2016-A00818-43。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf77/6492384/6c682a316797/13063_2019_3347_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf77/6492384/f35fbd6ec041/13063_2019_3347_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf77/6492384/6c682a316797/13063_2019_3347_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf77/6492384/f35fbd6ec041/13063_2019_3347_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf77/6492384/6c682a316797/13063_2019_3347_Fig2_HTML.jpg

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