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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of Eligible Participants Who Initiate the COR Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
COR Protocol
干预措施: COR Protocol (Body Compassion - Emotional Regulation - Conscious Reconnection with Food) (Behavioral)
结局指标
主要结局
Proportion of Eligible Participants Who Initiate the COR Intervention
时间窗: At enrollment.
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.
Proportion of Participants Who Complete All Eight COR Intervention Sessions
时间窗: Up to 8 weeks.
Retention during the intervention is defined as the proportion of participants who complete all eight scheduled COR intervention sessions.
Proportion of Participants Who Attend the 1-Month Follow-Up Session After Completing the COR Intervention
时间窗: Up to 12 weeks.
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.
Proportion of Participants Who Discontinue the COR Intervention Before Completing All Eight Sessions
时间窗: Up to 8 weeks.
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.
Proportion of Scheduled Assessment Instruments Completed by Participants
时间窗: From baseline through 12 weeks.
Assessment completeness is defined as the proportion of scheduled assessment instruments completed by participants relative to the total number of instruments planned. This includes both formal assessment batteries administered at predefined study time points and weekly monitoring measures collected during the intervention period. This outcome evaluates the feasibility of data collection procedures.
Acceptability of the COR Protocol Among Participants and Interventionists
时间窗: At completion of the eighth COR intervention session (session 8).
Acceptability of the COR protocol will be assessed using both participant- and interventionist-reported indicators. Participant acceptability will be assessed at post-treatment using the Client Satisfaction Questionnaire (CRES-4), which captures overall satisfaction with the intervention and perceived usefulness. Participant experiences regarding the intervention format, duration, contents, and strategies will be further explored through semi-structured qualitative interviews conducted after completion of the intervention. Interventionist acceptability will be assessed through semi-structured qualitative interviews focused on perceived adequacy, usability, and fit of the COR protocol within the clinical context.
Implementation Fidelity of the COR Protocol
时间窗: From the first COR intervention session (session 1) through completion of the eighth COR intervention session (session 8), assessed over 8 weeks.
Implementation fidelity of the COR protocol will be assessed by evaluating whether the intervention is delivered as intended. This includes assessment of (a) adherence to the core contents, objectives, and strategies specified for each session, (b) quality of intervention delivery (e.g., structure, clarity, and consistency with the COR model), and (c) participant exposure to the intervention (dose received), operationalized through session attendance, session duration, and completion of between-session tasks. Fidelity indicators will be primarily collected using a therapist-completed adherence checklist administered after each session, complemented by attendance and session-duration records. Descriptive information regarding implementation challenges and adaptations will also be recorded to support monitoring and future refinement of the protocol.
次要结局
- Change in Binge-Eating Symptoms(From baseline through 12 weeks.)
- Change in General Psychological Distress (CORE-OM)(From baseline through 12 weeks.)
- Change in Difficulties in Emotion Regulation (DERS)(From baseline through 12 weeks.)
- Change in Body Compassion(From baseline through 12 weeks.)
- Change in Emotional Eating(From baseline through 12 weeks.)
研究者
Neli Escandón Nagel
Associate Professor, Department of Psychology and Principal Investigator
Universidad Catolica de Temuco