About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
female;
aged 18 years or older;
self-report at least one binge eating episode over the past four weeks;
owned a smartphone;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
eMOTE
BehavioralThe intervention combines psychoeducation, mindfulness skills, emotion regulation skills, and distress tolerance skills, along with self-monitoring of meals, behaviours and feelings.
Treatment groups
Trial outcomes
Primary outcomes
Changes in binge eating symptoms
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
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.
Secondary outcomes
Changes in BMI
Assessed by a Body Composition Analyzer
Changes in intuitive eating
Assessed by Intuitive Eating Scale-2 - IES-2. The Intuitive Eating Scale-2 (IES-2) includes 23 items assessing various dimensions of intuitive eating. The total score on the IES-2 can range from 1 to 5, with higher scores indicate a greater tendency toward intuitive eating behaviors.
Changes in depression, anxiety and stress
Assessed by Depression, Anxiety and Stress Scale - 21 - DASS-21. The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-report questionnaire designed to measure levels of depression, anxiety, and stress. The scale provides three scores, one for each subscale, where the minimum is 0 and the maximum is 21, with higher scores indicate greater severity of emotional distress in each of these areas.
Changes in eating disorder psychopathology
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.
Other outcomes
Changes in emotion regulation
Assessed by Difficulties in Emotion Regulation Scale - DERS. The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report questionnaire designed to assess difficulties in emotional regulation. The total score on DERS can range from 36 to 180, with higher scores indicating greater difficulties in regulating emotions.
Changes in mindfulness
Assessed by Mindful Attention and Awareness Scale - MAAS. The Mindful Attention and Awareness Scale (MAAS) is a 15-item self-report instrument that measures the extent to which individuals act with awareness in daily life. The total score can range from 1 to 6, and higher scores indicate more mindfulness.
Sponsors and contacts
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