Trials / Recruiting
RecruitingNCT07327203
Video-based Guided Self Help Dialectical Behavior Therapy for Binge Eating Disorder
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The aim of this randomized controlled trial is to compare the efficacy of a video-based adaptation of guided self-help Dialectical Behavior Therapy for adults with Binge Eating Disorder (BED) with the traditional text-based guided self-help format. The study focuses on clinical remission of binge eating episodes, treatment adherence, and maintenance of therapeutic effects over time. Eighty adults diagnosed with BED will be recruited through the Eating Disorders Program of the Institute of Psychiatry at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil. Participants will be randomly assigned to one of two intervention groups. The experimental group will receive the content of the guided self-help DBT-BED manual delivered through weekly video lessons based on the book chapters. The control group will receive the same content in a traditional text-based guided self-help format, following the same weekly structure. Both groups will participate in six brief individual online guidance sessions with a psychologist, each lasting approximately 30 minutes. These sessions are intended to support treatment engagement, clarify intervention content, address treatment-interfering behaviors, promote generalization of DBT skills, and enhance motivation throughout the intervention. Assessments will be conducted at baseline, at the end of the intervention period, and at a 3-month follow-up. The primary outcome of the study will be complete remission of binge eating episodes at post-treatment and follow-up. Secondary outcomes will include changes in eating disorder psychopathology, emotional regulation, quality of life, self-esteem, and treatment dropout rates. The study is scheduled to begin in February 2026, with anticipated completion in December 2026.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Experimental: 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 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. |
| BEHAVIORAL | Traditional DBTgsh for BED (text-based model) | 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. |
Timeline
- Start date
- 2026-02-02
- Primary completion
- 2026-10-23
- Completion
- 2026-12-20
- First posted
- 2026-01-08
- Last updated
- 2026-02-04
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT07327203. Inclusion in this directory is not an endorsement.