Clinical trial NCT06683456: EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills
Official title: EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Binge Eating
Keywords: DBT
Binge Eating
Feeding and Eating Disorders
Application
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in binge eating symptoms
timeFrame: From Baseline to 2-months follow-up
measure: Changes in objective binge eating episodes
timeFrame: From Baseline to 2-months follow-up
Secondary outcomes:
measure: Changes in BMI
timeFrame: From Baseline to 2-months follow-up
measure: Changes in intuitive eating
timeFrame: From Baseline to 2-months follow-up
measure: Changes in depression, anxiety and stress
timeFrame: From Baseline to 2-months follow-up
measure: Changes in eating disorder psychopathology
timeFrame: From Baseline to 2-months follow-up
measure: Changes in subjective binge eating episodes
timeFrame: From Baseline to 2-months follow-up
measure: Changes in compensatory behaviors
timeFrame: From Baseline to 2-months follow-up
measure: Acceptability
timeFrame: T1 - immediately after intervention
Other outcomes:
measure: Changes in emotion regulation
timeFrame: From Baseline to 2-months follow-up
measure: Changes in mindfulness
timeFrame: From Baseline to 2-months follow-up
Locations:
city: Porto
country: Portugal
facility: Faculty of Psychology and Educational and Education Sciences
Study officials:
affiliation: Universidade do Porto
name: Telma Cruz, MSc
role: PRINCIPAL_INVESTIGATOR
References: