Video-based Guided Self Help Dialectical Behavior Therapy for Binge Eating Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Eating Disorder Examination Questionnaire (EDE-Q)
研究概览
简要总结
Dialectical Behavior Therapy (DBT) is an effective treatment for eating disorders, showing promising remission rates for Binge Eating Disorder (BED) in both standard and guided self-help formats. Traditional guided self-help models typically combine weekly chapter readings with a limited number of brief therapist meetings. However, the requirement of weekly book readings can be particularly challenging for individuals with BED, who often exhibit impulsive personality traits, psychiatric comorbidities, and weight-related health problems.
This study was developed to test a version of guided self-help DBT-BED delivered through video lessons instead of text. This randomized clinical trial will be conducted at the Eating Disorders Program of the Institute of Psychiatry, Hospital das Clínicas, Faculty of Medicine, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil. Eighty adults with BED will be randomized to either an experimental group (weekly video lessons) or a control group (weekly text-based readings).
Both groups will undergo a 13-week intervention, including six brief 30-minute online guidance sessions with a psychologist. The primary outcome will be full remission from binge eating episodes at the end of treatment and at the 3-month follow-up. Secondary outcomes will include changes in eating disorder psychopathology, emotion regulation, quality of life, self-esteem, and dropout rates. Statistical analyses will follow the intention-to-treat principle.
详细描述
The aim of this randomized controlled trial is to compare the efficacy of a video-based adaptation of guided self-help Dialectical Behavior Therapy for adults with Binge Eating Disorder (BED) with the traditional text-based guided self-help format. The study focuses on clinical remission of binge eating episodes, treatment adherence, and maintenance of therapeutic effects over time.
Eighty adults diagnosed with BED will be recruited through the Eating Disorders Program of the Institute of Psychiatry at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil. Participants will be randomly assigned to one of two intervention groups. The experimental group will receive the content of the guided self-help DBT-BED manual delivered through weekly video lessons based on the book chapters. The control group will receive the same content in a traditional text-based guided self-help format, following the same weekly structure.
Both groups will participate in six brief individual online guidance sessions with a psychologist, each lasting approximately 30 minutes. These sessions are intended to support treatment engagement, clarify intervention content, address treatment-interfering behaviors, promote generalization of DBT skills, and enhance motivation throughout the intervention.
Assessments will be conducted at baseline, at the end of the intervention period, and at a 3-month follow-up. The primary outcome of the study will be complete remission of binge eating episodes at post-treatment and follow-up. Secondary outcomes will include changes in eating disorder psychopathology, emotional regulation, quality of life, self-esteem, and treatment dropout rates.
The study is scheduled to begin in February 2026, with anticipated completion in December 2026.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with binge eating disorder according to the DSM-5-TR.
- •Access to a device with a camera, microphone, and internet connection.
- •Minimum ability to read and write in Portuguese.
- •Availability of 1 hour per week to read or watch treatment-related content.
- •Participants with psychiatric comorbidities must be on a stable medication regimen for at least two months prior to enrollment in the study.
排除标准
- •Individuals with anorexia nervosa or bulimia nervosa.
- •Individuals with unstable psychiatric comorbidities (exclusion will apply to individuals who have experienced an acute psychiatric exacerbation requiring additional treatment or medical hospitalization.).
- •Lack of time to read weekly chapters or watch the video lessons.
- •Inability to access devices with a camera, microphone, and internet.
- •Inability to attend six brief 30-minute videoconference sessions over the 13-week study period.
- •Individuals at imminent risk to life (suicidal or self-harming behavior in the previous three months).
- •Lack of minimum reading and writing skills.
研究组 & 干预措施
Video-based DBTgsh for BED
Participants assigned to the experimental group will receive a 13-week guided self-help intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly video lessons. The content is structured into three progressive modules covering core DBT skills: (1) mindfulness, (2) emotion regulation, and (3) distress tolerance. The video lessons will be adapted from the Portuguese version of The DBT Solution for Emotional Eating (Safer, Adler & Masson, 2020).
In addition to the video content, participants will have access to six brief online sessions with a psychologist (30 minutes each), conducted via videoconference. These sessions will be distributed as follows: two in the first two weeks, three biweekly, and one at the end of the treatment.
干预措施: Experimental: Video-based DBTgsh for BED (Behavioral)
Traditional DBTgsh for BED (text-based model)
Participants in the control group will receive the traditional guided self-help version of DBT-BED, using the guided self-help manual of The DBT Solution for Emotional Eating in the Portuguese version (Safer, Adler & Masson, 2020). Participants will be instructed to read one chapter per week over the 13-week treatment period. The content covers the same three core DBT modules: mindfulness skills, emotion regulation, and distress tolerance. As in the experimental group, participants will also participate in six online sessions with a psychologist (30 minutes each), following the same time schedule. These sessions will have the same objectives as those in the experimental group.
干预措施: Traditional DBTgsh for BED (text-based model) (Behavioral)
结局指标
主要结局
Eating Disorder Examination Questionnaire (EDE-Q)
时间窗: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.
Eating Disorder Examination Questionnaire (EDE-Q) is a self-report measure assessing the severity of eating disorder psychopathology, including binge eating-related symptoms. The global score is calculated as the mean of four subscales. Scores range from 0 to 6, with higher scores indicating greater eating disorder psychopathology.
次要结局
- Difficulties in Emotion Regulation Scale (DERS)(Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.)
- Short Form Health Survey (SF-36)(Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.)
- Rosenberg Self-Esteem Scale (RSES)(Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.)
研究者
Táki Athanássios Cordás
Coordinator, Eating Disorders Program
University of Sao Paulo General Hospital