NCT07327203

Brief Summary

Dialectical Behavior Therapy (DBT) is an effective treatment for eating disorders, showing promising remission rates for Binge Eating Disorder (BED) in both standard and guided self-help formats. Traditional guided self-help models typically combine weekly chapter readings with a limited number of brief therapist meetings. However, the requirement of weekly book readings can be particularly challenging for individuals with BED, who often exhibit impulsive personality traits, psychiatric comorbidities, and weight-related health problems. This study was developed to test a version of guided self-help DBT-BED delivered through video lessons instead of text. This randomized clinical trial will be conducted at the Eating Disorders Program of the Institute of Psychiatry, Hospital das Clínicas, Faculty of Medicine, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil. Eighty adults with BED will be randomized to either an experimental group (weekly video lessons) or a control group (weekly text-based readings). Both groups will undergo a 13-week intervention, including six brief 30-minute online guidance sessions with a psychologist. The primary outcome will be full remission from binge eating episodes at the end of treatment and at the 3-month follow-up. Secondary outcomes will include changes in eating disorder psychopathology, emotion regulation, quality of life, self-esteem, and dropout rates. Statistical analyses will follow the intention-to-treat principle.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress30%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

December 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

December 25, 2025

Last Update Submit

February 3, 2026

Conditions

Keywords

BEDDBTDialectical Behavior TherapyGuided Self-HelpVideo-based interventionDBT-BEDDBTgsh

Outcome Measures

Primary Outcomes (1)

  • Eating Disorder Examination Questionnaire (EDE-Q)

    Eating Disorder Examination Questionnaire (EDE-Q) is a self-report measure assessing the severity of eating disorder psychopathology, including binge eating-related symptoms. The global score is calculated as the mean of four subscales. Scores range from 0 to 6, with higher scores indicating greater eating disorder psychopathology.

    Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.

Secondary Outcomes (3)

  • Difficulties in Emotion Regulation Scale (DERS)

    Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.

  • Short Form Health Survey (SF-36)

    Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.

  • Rosenberg Self-Esteem Scale (RSES)

    Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.

Study Arms (2)

Video-based DBTgsh for BED

EXPERIMENTAL

Participants assigned to the experimental group will receive a 13-week guided self-help intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly video lessons. The content is structured into three progressive modules covering core DBT skills: (1) mindfulness, (2) emotion regulation, and (3) distress tolerance. The video lessons will be adapted from the Portuguese version of The DBT Solution for Emotional Eating (Safer, Adler \& Masson, 2020). In addition to the video content, participants will have access to six brief online sessions with a psychologist (30 minutes each), conducted via videoconference. These sessions will be distributed as follows: two in the first two weeks, three biweekly, and one at the end of the treatment.

Behavioral: Experimental: Video-based DBTgsh for BED

Traditional DBTgsh for BED (text-based model)

ACTIVE COMPARATOR

Participants in the control group will receive the traditional guided self-help version of DBT-BED, using the guided self-help manual of The DBT Solution for Emotional Eating in the Portuguese version (Safer, Adler \& Masson, 2020). Participants will be instructed to read one chapter per week over the 13-week treatment period. The content covers the same three core DBT modules: mindfulness skills, emotion regulation, and distress tolerance. As in the experimental group, participants will also participate in six online sessions with a psychologist (30 minutes each), following the same time schedule. These sessions will have the same objectives as those in the experimental group.

Behavioral: Traditional DBTgsh for BED (text-based model)

Interventions

This is a guided self-help behavioral intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly pre-recorded video lessons over 13 weeks. The intervention covers three core DBT skill modules-mindfulness, emotion regulation, and distress tolerance-and is supported by six brief 30-minute individual online guidance sessions with a psychologist to enhance adherence, clarify content, and support skill application.

Video-based DBTgsh for BED

This is a guided self-help behavioral intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly chapter readings from a structured manual over 13 weeks. The intervention covers the same three core DBT skill modules-mindfulness, emotion regulation, and distress tolerance-and is supported by six brief 30-minute individual online guidance sessions with a psychologist to enhance adherence, clarify content, and support skill application.

Traditional DBTgsh for BED (text-based model)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals diagnosed with binge eating disorder according to the DSM-5-TR.
  • Access to a device with a camera, microphone, and internet connection.
  • Minimum ability to read and write in Portuguese.
  • Availability of 1 hour per week to read or watch treatment-related content.
  • Participants with psychiatric comorbidities must be on a stable medication regimen for at least two months prior to enrollment in the study.

You may not qualify if:

  • Individuals with anorexia nervosa or bulimia nervosa.
  • Lack of time to read weekly chapters or watch the video lessons.
  • Inability to access devices with a camera, microphone, and internet.
  • Inability to attend six brief 30-minute videoconference sessions over the 13-week study period.
  • Individuals at imminent risk to life (suicidal or self-harming behavior in the previous three months).
  • Lack of minimum reading and writing skills.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMBULIM IPq HC FMUSP

São Paulo, São Paulo, 05403-903, Brazil

RECRUITING

Related Publications (1)

  • Ben-Porath, D., Duthu, F., Luo, T., Gonidakis, F., Compte, E. J., & Wisniewski, L. (2020). Dialectical behavioral therapy: an update and review of the existing treatment models adapted for adults with eating disorders. Dialectical Behavior Therapy for Eating Disorders, 5-25. DOI: 10.1080/10640266.2020.1723371. Carter, J. C., Kenny, T. E., Singleton, C., Van Wijk, M., & Heath, O. (2020). Dialectical behavior therapy self-help for binge-eating disorder: A randomized controlled study. International Journal of Eating Disorders, 53(3), 451-460.Masson, P. C., von Ranson, K. M., Wallace, L. M., & Safer, D. L. (2013). A randomized wait-list controlled pilot study of dialectical behaviour therapy guided self-help for binge eating disorder. Behaviour research and therapy, 51(11), 723-728.Safer, D. L., Adler, S., & Masson, P. C. (2018). The DBT solution for emotional eating: A proven program to break the cycle of bingeing and out-of-control eating. Guilford Publications.

    BACKGROUND

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Beds

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Equipment and Supplies, HospitalEquipment and Supplies

Study Officials

  • Táki Cordas, Medical Coordinator

    Eating Disorders Program of the Psychiatry Institute, Hospital das Clínicas, Medical School, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil.

    STUDY DIRECTOR

Central Study Contacts

Fellipe Augusto Lenzing, Clinical Research Supervisor

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
Coordinator, Eating Disorders Program

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 8, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

October 23, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations