在线认知行为疗法增强治疗暴食障碍：一项随机对照试验的研究方案。
Online cognitive behavioral therapy enhanced for binge eating disorder: study protocol for a randomized controlled trial.
机构信息
Novarum Center for Eating Disorders & Obesity, Jacob Obrechtstraat 92, 1071, KR, Amsterdam, the Netherlands.
Research Department, Arkin Mental Health Institute, Klaprozenweg 111, 1033, NN, Amsterdam, the Netherlands.
出版信息
BMC Psychiatry. 2020 Apr 29;20(1):190. doi: 10.1186/s12888-020-02604-1.
BACKGROUND
Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavioral Therapy-Enhanced and guided self-help treatment are recommended. As online treatment offers several additional advantages, we have developed a CBT-Enhanced online guided self-help intervention. The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition. The experimental condition is hypothesized to be superior to the waiting list condition.
METHODS
The efficacy of an online guided self-help intervention for binge eating disorder will be assessed by conducting a randomized controlled trial. The trial will target adult individuals classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder with a body mass index between 19.5 and 40, referred to an eating disorder treatment center. Dual arm allotment will be performed in a 1:1 ratio stratified for BMI above or below 30. Randomization will be blinded to the online intervention (n = 90), or to the control waiting list condition (n = 90). Assessors will be blinded and assessments will be administered at baseline, week 5, at end-of-treatment, and at 12 and 24 weeks follow-up. Primary outcome will be eating disorder pathology, operationalized as number of days on which binge eating occurred between the two conditions during the period of the intervention. Secondary outcome measures will be differences in other eating disorder pathology, clinical impairment and in quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators. Several types of costs will be assessed.
DISCUSSION
This paper presents an online guided self-help Cognitive Behavioral Therapy- Enhanced study protocol for individuals classified with binge eating disorder or other specified feeding or eating disorder. Efficacy will be examined through a Randomized Controlled Trial.
TRIAL REGISTRATION
The study protocol is registered with the Netherlands Trial Registry NTR (NTR 7994) since 6 September 2019.
背景
暴食症的特征是反复发作的暴食发作，伴有失控感。在现有的不同治疗方法中，推荐使用认知行为治疗增强和指导自助治疗。由于在线治疗具有多项额外优势，我们已经开发了一种 CBT 增强型在线指导自助干预措施。本研究的目的是确定与未治疗的等待名单条件相比，这种干预是否能减少暴食障碍患者的病理变化，增加无暴食发作天数。实验组被假设优于等待名单组。
方法
通过进行随机对照试验，评估在线指导自助干预暴食症的疗效。该试验将针对被诊断为暴食症或其他特定喂养或进食障碍-暴食症的成年患者，其身体质量指数在 19.5 至 40 之间，被转介到饮食失调治疗中心。双臂分配将按 BMI 高于或低于 30 进行分层，比例为 1:1。随机分配将对在线干预（n=90）或对照等待名单条件（n=90）进行盲法。评估者将进行盲法，评估将在基线、第 5 周、治疗结束时以及 12 周和 24 周随访时进行。主要结局将是饮食失调病理，即干预期间两种情况下暴食发作的天数。次要结局指标将是其他饮食失调病理、临床损伤和生活质量的差异，而治疗联盟、人口统计学特征和所遵循的治疗模块将作为效应调节剂。将评估几种类型的成本。
讨论
本文提出了一种针对暴食症或其他特定喂养或进食障碍患者的在线指导自助认知行为治疗增强研究方案。通过随机对照试验来检查疗效。
试验注册
该研究方案于 2019 年 9 月 6 日在荷兰试验注册处（NTR）注册（NTR 7994）。
Zotero 插件