EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Changes in binge eating symptoms
研究概览
简要总结
Binge eating, whether formally diagnosed or occurring at subthreshold levels, is associated with adverse health consequences and decreased quality of life.
Access to accessible, cost-effective interventions that effectively address binge eating episodes is critical for individuals with this condition, and smartphone applications have demonstrated promise in treating binge eating and related disorders.
This study aims to evaluate the efficacy of eMOTE, a novel smartphone application for binge eating based on Dialectical Behavior Therapy (DBT) skills. For this purpose, a randomized controlled trial will be conducted in which women who self-report binge eating episodes will be randomly assigned to the app intervention group or a waiting list group.
详细描述
eMOTE is a self-help application for women struggling with binge eating episodes. The application was developed based on DBT skills and has four modules: psychoeducation, mindfulness skills, emotion regulation skills, and distress tolerance skills. Additionally, it includes two self-monitoring diaries that allow the input of data related to food, behaviors, feelings, and exercises. The application content will be delivered through text, audios, and videos.
For this study, adult individuals with binge eating episodes who are fluent in Portuguese and own a smartphone will be recruited. The recruitment will be conducted through social media, the University of Porto, and other relevant institutions.
Participants who enrol in eMOTE will be required to fill out online self-report instruments and provide their body mass index (BMI) at baseline (T0), two months (T1), and four months after randomization (T2). A researcher not involved in the study will conduct the randomization process.
Participants will be randomly allocated to two groups: the experimental and control groups. In the experimental group, the participants will have access to eMOTE for eight weeks, while in the control group, the participants will be on a waiting list for eight weeks, and after this period, the participants will have access to eMOTE. The investigators will analyze the changes in the frequency of objective and subjective binge eating episodes, eating disorder psychopathology, BMI, intuitive eating, depression, anxiety, stress, compensatory behaviors, mindfulness, and difficulties in emotion 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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 18 years or older;
- •self-report at least one binge eating episode over the past four weeks;
- •owned a smartphone;
- •fluent in Portuguese.
排除标准
- •attending psychotherapy (face-to-face or digital) or another clinical trial;
- •body mass index below 18.5;
- •self-report an average of eight or more episodes of binge eating or inappropriate compensatory behaviours per week;
- •being pregnant;
- •self-report bipolar disorder, psychotic disorder, substance abuse, suicidal ideation or borderline personality disorder.
研究组 & 干预措施
eMOTE
Participants will have access to eMOTE for eight weeks.
干预措施: eMOTE (Behavioral)
Waiting List
Participants will be on a waiting list group for eight weeks. After that period, the participants will have access to eMOTE.
结局指标
主要结局
Changes in binge eating symptoms
时间窗: From Baseline to 2-months follow-up
Assessed by Binge Eating Scale - BES. The Binge Eating Scale (BES) is a 16-item self-report questionnaire used to assess the presence and severity of binge eating behaviors. The scale's total score can range from 0 to 46, with higher scores indicating more severe levels of binge eating.
Changes in objective binge eating episodes
时间窗: From Baseline to 2-months follow-up
Assessed by Eating Disorder Examination Questionnaire - EDE-Q. The Eating Disorder Examination Questionnaire (EDE-Q) is a 36-item self-report tool designed to assess the range, frequency, and severity of behaviors associated with eating disorder diagnoses. The total score on the EDE-Q can range from 0 to 6, with higher scores indicating more severe eating difficulties.
次要结局
- Changes in BMI(From Baseline to 2-months follow-up)
- Changes in intuitive eating(From Baseline to 2-months follow-up)
- Changes in depression, anxiety and stress(From Baseline to 2-months follow-up)
- Changes in eating disorder psychopathology(From Baseline to 2-months follow-up)
- Changes in subjective binge eating episodes(From Baseline to 2-months follow-up)
- Changes in compensatory behaviors(From Baseline to 2-months follow-up)
- Acceptability(T1 - immediately after intervention)