跳至主要内容
临床试验/NCT04101032
NCT04101032Unknown不适用

eBEfree - an ICT Adaptation of BEfree: an APP Delivered Programme Based on Mindfulness, Values, and Compassion for Binge Eating

University of Coimbra0 个研究点目标入组 70 人开始时间: 2019年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
主要终点
Reductions in BE symptoms and other disordered eating and body image symptoms

研究概览

简要总结

The eBEfree project aims at testing the effectiveness of an information and communication technology-based delivery version of BEfree in individuals with obesity and Binge Eating Disorder (BED). BED is a serious public health concern, given its prevalence, psychiatric comorbidity and association with obesity, which is currently a major health and economic challenge of epidemic proportions. BED affects obesity onset, maintenance and treatment. BEfree is a 12-session face-to-face group intervention for BED, developed by the current project research team, that integrates mindfulness, compassion, and values. BEfree was found to be effective in treating BED and in improving psychological adjustment. ICT-based interventions are a cost-effective form of treatment delivery that may increase treatment accessibility for individuals with BED and obesity. This project will directly contribute to the treatment of these conditions and improvement of health services at regional and national levels.

详细描述

The current project aims at developing a mobile-app adapted version of BEfree - eBEfree - as well as test the efficacy of this ICT-delivery version in a sample of participants with obesity and BED. The specific objectives of the project are:

  1. Develop an ICT-delivery version of BEfree: eBEfree.
  2. Examine the effectiveness of the ICT-delivery version eBEfree.
  3. Test the stability of the outcomes over 6 months.
  4. Compare the effectiveness of the eBEfree and the face-to-face version of BEfree.
  5. Analyse eBEfree cost-effectiveness.

A detailed description of the aims of the project are presented below.

  1. Developing the ICT-delivery version of BEfree - eBEfree. This toolkit will be developed based on the original manual of the face-to-face version of BEfree and will include the tools targeted in BEfree to support participants in reducing BE symptomatology and improve psychological well-being. These tools will cover three main areas:

i) Mindfulness skills to promote adaptive emotion regulation and improve eating behaviour regulation; ii) Compassion skills to promote motivation that supports sustained adaptive behaviour regulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • overweight and obesity (IMC ≥ 25 using a Body Mass Analyzer TANITA-SC-330);
  • BED (confirmed through the Eating Disorder Examination 17.0D;
  • Access to smartphone and willingness to use it regularly (at least once a week).

排除标准

  • undergoing any other form of psychological intervention for BED or having attended the face-to-face BEfree;
  • severe psychiatric problem (e.g., major depression; psychotic illness; bipolar disorder, assessed through a semi-structured interview using DSM-5 criteria).

研究组 & 干预措施

eBEfree

Experimental

eBEfree is a ICT-delivery version of BEfree - eBEfree that comprises 12 online sessions, based on mindfulness,values and compassion components for women with Binge Eating.

干预措施: eBEfree (Behavioral)

Waiting List

No Intervention

Participants will remain in a waiting list. After 12 weeks, they will be offered the same intervention.

结局指标

主要结局

Reductions in BE symptoms and other disordered eating and body image symptoms

时间窗: 9 months (from baseline to 6 months follow-up)

Assessed by EDE interview

次要结局

  • Weight loss(9 months (from baseline to 6 months follow-up))
  • Reductions in depressive symptoms(9 months (from baseline to 6 months follow-up))
  • Increasing well-being(9 months (from baseline to 6 months follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Augusto Pinto Gouveia

Principal Investigator

University of Coimbra

相似试验