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Идёт набор NCT06683456

EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills

Без фазы С лечением Binge Eating

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: eMOTE.
Кому может быть актуально
Состояния в реестре: Binge Eating. Базовые параметры: 18 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Португалия
Следующий шаг
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Официальное название

EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое eMOTE
    The intervention combines psychoeducation, mindfulness skills, emotion regulation skills, and distress tolerance skills, along with self-monitoring of meals, behaviours and feelings.

Первичные конечные точки

  • Changes in binge eating symptoms [Срок оценки: From Baseline to 2-months follow-up]
  • Changes in objective binge eating episodes [Срок оценки: From Baseline to 2-months follow-up]
Вторичные конечные точки (7)
  • Changes in BMI [Срок оценки: From Baseline to 2-months follow-up]
  • Changes in intuitive eating [Срок оценки: From Baseline to 2-months follow-up]
  • Changes in depression, anxiety and stress [Срок оценки: From Baseline to 2-months follow-up]
  • Changes in eating disorder psychopathology [Срок оценки: From Baseline to 2-months follow-up]
  • Changes in subjective binge eating episodes [Срок оценки: From Baseline to 2-months follow-up]
  • Changes in compensatory behaviors [Срок оценки: From Baseline to 2-months follow-up]
  • Acceptability [Срок оценки: T1 - immediately after intervention]

Критерии участия

Критерии включения

  • female;
  • aged 18 years or older;
  • self-report at least one binge eating episode over the past four weeks;
  • owned a smartphone;
  • fluent in Portuguese.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Португалия · 1 центр
  • Faculty of Psychology and Educational and Education Sciences — Porto

Идентификаторы

NCT: NCT06683456 · FPCEUP/RH5

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗