NCT04101032

Brief Summary

The eBEfree project aims at testing the effectiveness of an information and communication technology-based delivery version of BEfree in individuals with obesity and Binge Eating Disorder (BED). BED is a serious public health concern, given its prevalence, psychiatric comorbidity and association with obesity, which is currently a major health and economic challenge of epidemic proportions. BED affects obesity onset, maintenance and treatment. BEfree is a 12-session face-to-face group intervention for BED, developed by the current project research team, that integrates mindfulness, compassion, and values. BEfree was found to be effective in treating BED and in improving psychological adjustment. ICT-based interventions are a cost-effective form of treatment delivery that may increase treatment accessibility for individuals with BED and obesity. This project will directly contribute to the treatment of these conditions and improvement of health services at regional and national levels.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

July 26, 2019

Last Update Submit

September 23, 2019

Conditions

Keywords

MindfulnessSelf-compassionValuesBinge Eating

Outcome Measures

Primary Outcomes (2)

  • Reductions in BE symptoms and other disordered eating and body image symptoms

    Assessed by EDE interview

    9 months (from baseline to 6 months follow-up)

  • Reductions in BE symptoms and other disordered eating and body image symptoms

    Assessed by Binge Eating Scale

    9 months (from baseline to 6 months follow-up)

Secondary Outcomes (3)

  • Weight loss

    9 months (from baseline to 6 months follow-up)

  • Reductions in depressive symptoms

    9 months (from baseline to 6 months follow-up)

  • Increasing well-being

    9 months (from baseline to 6 months follow-up)

Other Outcomes (7)

  • Increase in self-compassion

    9 months (from baseline to 6 months follow-up)

  • Increase in mindfulness

    9 months (from baseline to 6 months follow-up)

  • Increase in engagement with valued living

    9 months (from baseline to 6 months follow-up)

  • +4 more other outcomes

Study Arms (2)

eBEfree

EXPERIMENTAL

eBEfree is a ICT-delivery version of BEfree - eBEfree that comprises 12 online sessions, based on mindfulness,values and compassion components for women with Binge Eating.

Behavioral: eBEfree

Waiting List

NO INTERVENTION

Participants will remain in a waiting list. After 12 weeks, they will be offered the same intervention.

Interventions

eBEfreeBEHAVIORAL

Contextual interventions based on promoting acceptance,mindfulness and self-compassion abilities

eBEfree

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • overweight and obesity (IMC ≥ 25 using a Body Mass Analyzer TANITA-SC-330);
  • BED (confirmed through the Eating Disorder Examination 17.0D;
  • Access to smartphone and willingness to use it regularly (at least once a week).

You may not qualify if:

  • undergoing any other form of psychological intervention for BED or having attended the face-to-face BEfree;
  • severe psychiatric problem (e.g., major depression; psychotic illness; bipolar disorder, assessed through a semi-structured interview using DSM-5 criteria).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Pinto-Gouveia J, Carvalho SA, Palmeira L, Castilho P, Duarte C, Ferreira C, Duarte J, Cunha M, Matos M, Costa J. Incorporating psychoeducation, mindfulness and self-compassion in a new programme for binge eating (BEfree): Exploring processes of change. J Health Psychol. 2019 Mar;24(4):466-479. doi: 10.1177/1359105316676628. Epub 2016 Nov 15.

    PMID: 27852886BACKGROUND
  • Pinto-Gouveia J, Carvalho SA, Palmeira L, Castilho P, Duarte C, Ferreira C, Duarte J, Cunha M, Matos M, Costa J. BEfree: A new psychological program for binge eating that integrates psychoeducation, mindfulness, and compassion. Clin Psychol Psychother. 2017 Sep;24(5):1090-1098. doi: 10.1002/cpp.2072. Epub 2017 Jan 25.

    PMID: 28124451BACKGROUND
  • Senra H, Duarte C, Carvalho SA, Simoes L, Ferreira C, Palmeira L, Matos M, Cunha M, Castilho P, Sousa B, Cordeiro L, Pinto-Gouveia J. eBEfree: Combining Psychoeducation, Mindfulness, and Self-Compassion in an App-Based Psychological Intervention to Manage Binge-Eating Symptoms: A Randomized Controlled Trial. Int J Eat Disord. 2025 Jul;58(7):1199-1218. doi: 10.1002/eat.24432. Epub 2025 Mar 29.

MeSH Terms

Conditions

Binge-Eating DisorderBulimia

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • José Augusto Pinto Gouveia, PhD

    University of Coimbra

    PRINCIPAL INVESTIGATOR

Central Study Contacts

José Augusto Pinto Gouveia, PhD

CONTACT

Cristiana Duarte, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2019

First Posted

September 24, 2019

Study Start

October 14, 2019

Primary Completion

December 30, 2019

Study Completion

July 1, 2021

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share