COR Protocol for the Treatment of Binge Eating in Chilean Adults (COR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Catolica de Temuco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
COR Protocol (Body Compassion - Emotional Regulation - Conscious Reconnection with Food)
BehavioralThe 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 principles of intuitive eating, within a non-weight-centered and compassion-focused framework. The intervention targets key psychological processes involved in binge eating, including emotional regulation, responses to food-related urges and cravings, and the development of a more compassionate relationship with the body and eating. Sessions include psychoeducation, functional analysis of binge episodes, experiential exercises, brief regulation practices, and reflective between-session activities.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: COR ProtocolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Eligible Participants Who Initiate the COR Intervention
Recruitment rate is defined as the proportion of eligible individuals who begin the COR intervention, calculated as the number of eligible participants who start the intervention divided by the number of eligible individuals who were successfully contacted and formally invited to participate during the recruitment period.
Time frame
At enrollment.2
Proportion of Participants Who Complete All Eight COR Intervention Sessions
Retention during the intervention is defined as the proportion of participants who complete all eight scheduled COR intervention sessions.
Time frame
Up to 8 weeks.3
Proportion of Participants Who Attend the 1-Month Follow-Up Session After Completing the COR Intervention
Retention at follow-up is defined as the proportion of participants who completed the eighth COR intervention session and subsequently attended the 1-month follow-up session.
Time frame
Up to 12 weeks.4
Proportion of Participants Who Discontinue the COR Intervention Before Completing All Eight Sessions
Dropout rate is defined as the proportion of participants who discontinue the COR intervention before completing all eight scheduled sessions. When available, participants' self-reported reasons for discontinuation will be recorded descriptively.
Time frame
Up to 8 weeks.Secondary outcomes
1
Change in Binge-Eating Symptoms
Changes in binge-eating symptoms, including the frequency and severity of binge-eating-related behaviors and associated distress, will be assessed using validated self-report measures, including the Eating Disorder-15 (ED-15) and the Binge Eating Disorder Screener-7 (BEDS-7). In addition to the predefined assessment time points, the ED-15 will be administered weekly during the intervention period for monitoring purposes.
Time frame
From baseline through 12 weeks.2
Change in General Psychological Distress (CORE-OM)
General psychological distress will be assessed using the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), a self-report questionnaire that measures overall psychological distress and well-being. This outcome will be used to describe changes in general distress during and after participation in the COR intervention and to support monitoring of participant well-being.
Time frame
From baseline through 12 weeks.3
Change in Difficulties in Emotion Regulation (DERS)
Difficulties in emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS), a self-report questionnaire that measures difficulties in understanding, accepting, and managing emotions. This outcome will be used to describe changes in emotion regulation difficulties following participation in the COR intervention.
Time frame
From baseline through 12 weeks.4
Change in Body Compassion
Changes in body compassion will be assessed using the Body Compassion Scale (BCS), a self-report measure designed to assess compassionate attitudes toward the body.
Time frame
From baseline through 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Catolica de Temuco
Lead sponsor
Agencia Nacional de Investigación y Desarrollo
Collaborator
Source ClinicalTrials.gov