COR Protocol for the Treatment of Binge Eating in Chilean Adults (COR)

Официальное название

A Pilot Study on the Feasibility and Acceptability of the COR (Body Compassion-Emotional Regulation-Conscious Reconnection With Eating) Protocol for Addressing Binge Eating in Chilean Adults

Обзор

The goal of this clinical study is to learn whether a brief online psychological program called COR can be delivered in a feasible and acceptable way for adults who experience recurrent binge eating. The main questions this study aims to answer are: * Is the COR program acceptable to participants, in terms of satisfaction, adherence, and dropout rates? * Is the COR program feasible to deliver online, including recruitment, retention, and completion of sessions and questionnaires? * Do participants show preliminary changes over time in binge eating-related distress and emotional well-being? Participants in this study are adults who experience recurrent episodes of binge eating. They will take part in an individual online intervention that includes eight weekly sessions, a brief pre-session, and a follow-up session one month after the end of treatment. During the study, participants will: * Attend weekly online sessions focused on understanding binge eating, emotions, and the relationship with food and the body * Practice simple exercises to help manage emotional distress and food-related urges * Complete short questionnaires before, during, and after the intervention to describe their experiences The information from this study will help researchers understand whether this type of intervention can be used in future, larger studies and in real-world clinical settings.

Подробное описание

This study evaluates the COR protocol (Body Compassion-Emotional Regulation-Conscious Reconnection with Food), a brief, manualized psychological intervention designed for adults who experience recurrent binge eating. The study is conducted as a pilot trial to examine implementation-related outcomes and to explore preliminary clinical changes over time.

The COR protocol was developed by integrating evidence-informed components from cognitive-behavioral therapy for eating disorders, dialectical behavior therapy skills, and approaches that promote a more conscious and flexible relationship with eating. The intervention is grounded in a non-weight-centered framework and places emphasis on emotional regulation, experiential work with urges and cravings, and the gradual development of a more compassionate relationship with the body and eating.

The intervention is delivered individually in an online format and consists of eight weekly sessions, preceded by a brief pre-session and followed by a one-month follow-up session. Sessions follow a structured but flexible progression, organized around a defined trajectory of change. Early sessions focus on establishing a therapeutic framework, understanding binge eating as a functional and emotionally driven behavior, and identifying personal vulnerability patterns. Middle sessions emphasize skills for relating differently to urges and emotional distress, including experiential and regulation-based strategies. Later sessions focus on body-related self-criticism, compassion-based practices, consolidation of skills, and planning for continuity of care and relapse prevention.

Each session includes a combination of psychoeducation, guided experiential exercises, reflective discussion, and brief between-session practices. Between-session tasks are designed to support observation and reflection rather than performance or compliance, and difficulties completing tasks are addressed as clinically meaningful information rather than treatment failure.

The protocol is manualized to support consistency across providers while allowing controlled clinical flexibility in pacing, examples, and depth of exploration, according to participant needs. Core components of each session and overarching therapeutic principles are defined as non-modifiable to preserve fidelity to the model.

As part of the study design, the COR protocol is implemented by psychologists with general clinical training who receive structured training in the model prior to implementation, as well as ongoing weekly clinical supervision during the intervention period. Therapist adherence to the protocol is supported through the use of structured adherence checklists, which are intended for monitoring and quality assurance rather than performance evaluation.

This pilot study focuses on outcomes related to feasibility and acceptability of the intervention when delivered online, including aspects of recruitment, retention, adherence, and participant satisfaction. In addition, the study explores preliminary changes over time in binge eating-related symptoms and associated emotional and psychological processes. Data from this pilot will be used to inform refinements to the protocol and the design of future larger-scale studies.

Вмешательства

• Поведенческое COR Protocol (Body Compassion - Emotional Regulation - Conscious Reconnection with Food)
  The COR protocol (Body Compassion-Emotional Regulation-Conscious Reconnection with Food) is a brief, manualized psychological intervention designed to address recurrent binge eating in adults. The intervention is delivered individually in an online format and consists of eight weekly sessions, preceded by an initial pre-session and followed by a one-month follow-up session. COR integrates elements from cognitive-behavioral therapy for eating disorders, dialectical behavior therapy skills, and p

Первичные конечные точки

• Proportion of Eligible Participants Who Initiate the COR Intervention [Срок оценки: At enrollment.]
• Proportion of Participants Who Complete All Eight COR Intervention Sessions [Срок оценки: Up to 8 weeks.]
• Proportion of Participants Who Attend the 1-Month Follow-Up Session After Completing the COR Intervention [Срок оценки: Up to 12 weeks.]
• Proportion of Participants Who Discontinue the COR Intervention Before Completing All Eight Sessions [Срок оценки: Up to 8 weeks.]
• Proportion of Scheduled Assessment Instruments Completed by Participants [Срок оценки: From baseline through 12 weeks.]
• Acceptability of the COR Protocol Among Participants and Interventionists [Срок оценки: At completion of the eighth COR intervention session (session 8).]
• Implementation Fidelity of the COR Protocol [Срок оценки: From the first COR intervention session (session 1) through completion of the eighth COR intervention session (session 8), assessed over 8 weeks.]

Вторичные конечные точки (5)

• Change in Binge-Eating Symptoms [Срок оценки: From baseline through 12 weeks.]
• Change in General Psychological Distress (CORE-OM) [Срок оценки: From baseline through 12 weeks.]
• Change in Difficulties in Emotion Regulation (DERS) [Срок оценки: From baseline through 12 weeks.]
• Change in Body Compassion [Срок оценки: From baseline through 12 weeks.]
• Change in Emotional Eating [Срок оценки: From baseline through 12 weeks.]

Критерии участия

Критерии включения

• Adults aged 18 years or older.
• Overweight or obesity, based on self-report.
• At least three binge-eating episodes in the past 30 days, associated with psychological distress.
• The presence of chronic medical conditions commonly associated with overweight or obesity (e.g., hypothyroidism, hyperthyroidism, dyslipidemia, hypertension, type 2 diabetes mellitus, or polycystic ovary syndrome) is permitted, provided that such conditions are medically stable.
• If present, chronic medical conditions must be medically stable, defined as:
• stable medical treatment for at least 12 weeks,
• no recent changes in medication,
• no acute clinical decompensation or recent major cardiovascular events,
• at least one related medical follow-up visit in the past 12 months.
• If present, psychopharmacological treatment must be stable, defined as no changes in medication type or dosage during the 12 weeks prior to enrollment.
• Daily access to the internet and to a computer or smartphone that allows participation in online sessions and assessments.

Критерии исключения

• Current compensatory behaviors associated with binge eating, such as self-induced vomiting and/or regular use of laxatives, within the past 60 days.

• Pregnancy or breastfeeding at the time of the initial assessment.
• History of bariatric surgery.
• Active suicidal ideation
• Current symptoms consistent with severe mental disorders, such as psychotic disorders, bipolar disorder, complex post-traumatic stress disorder, or severe personality disorders, when associated with marked functional impairment or the need for specialized or higher-intensity clinical care.
• Current substance use pattern that, due to its severity or functional impact, requires specialized clinical treatment.
• Ongoing psychological and/or nutritional treatment at the time of enrollment, defined as regular sessions or an active treatment plan, regardless of treatment focus or therapeutic approach.
• Presence of active or medically unstable conditions, characterized by clinically significant symptoms, lack of medical follow-up, or recent changes in medication, that could interfere with participation in the intervention or substantially affect eating behavior or mood.
• Significant functional impairment that, in the clinical judgment of the research team, would limit the participant's ability to engage safely and consistently in the intervention.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Universidad Católica de Temuco — Temuco

Идентификаторы

NCT: NCT07435974 · Fondecyt Iniciacion 11230678

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗