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

NCT06683456 | Recruiting

• 1 other identifier: FPCEUP/RH5
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating

Keywords

DBT; Binge Eating; Feeding and Eating Disorders; Application

Outcome Measures

Primary Outcomes (2)

• 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.

  From Baseline to 2-months follow-up

• 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.

  From Baseline to 2-months follow-up

Secondary Outcomes (7)

• 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

Other Outcomes (2)

• Changes in emotion regulation

  From Baseline to 2-months follow-up

• Changes in mindfulness

  From Baseline to 2-months follow-up

Study Arms (2)

eMOTE

EXPERIMENTAL

Participants will have access to eMOTE for eight weeks.

Behavioral: eMOTE

Waiting List

NO INTERVENTION

Participants will be on a waiting list group for eight weeks. After that period, the participants will have access to eMOTE.

Interventions

eMOTE BEHAVIORAL

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

eMOTE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculty of Psychology and Educational and Education Sciences

Porto, Porto District, 4200-135, Portugal

RECRUITING

MeSH Terms

Conditions

Bulimia; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Telma Cruz, MSc

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Telma Cruz, MSc

CONTACT

220400667; telmandreiacruz@gmail.com

Mariana Martins, PhD

CONTACT

220400667; mmartins@fpce.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: November 12, 2024
• Study Start: April 1, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)