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临床试验/NCT07512479
NCT07512479已完成不适用

A Randomized Control Pilot Study With a Parallel Group Design, on the Effectiveness of Hatha Yoga and From Feeling to Seeing the Body - Embodied Experience Intervention for Body Image (FSB) in the Treatment of Body Image in Female Adolescents and Young Adults With Eating Disorder.

Azienda Ulss 2 Marca Trevigiana1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
1
主要终点
Body Dissatisfaction and Dysfunctional Eating Behaviors as Measured by the Eating Disorder Inventory-3 (EDI-3)

研究概览

简要总结

The goal of this clinical trial is to investigate the effectiveness of two types of intervention (Hatha Yoga and FSB From Feeling to Seeing the Body - Embodied Experience Intervention for body image) on eating behaviour and body dissatisfaction in females aged 16-25 with eating disorders. The main questions the study aims to answer are:

  • Do Hatha Yoga and FSB Intervention have an impact on eating behavior and reductions in body dissatisfaction?
  • How do Hatha Yoga and FSB Intervention influence underlying mechanisms such as embodiment, interoceptive awareness, body and functionality appreciation, mindfulness and self-compassion? Researchers will compare the outcomes with a control group that will receive only standard treatment to determine whether the specific Hatha Yoga and FSB interventions have an impact on body dissatisfaction and eating behaviors.

Participants will be divided into three groups:

  • Control Group (C): patients will continue with treatment as usual (TAU) which consists of periodic psychiatric, psychotherapeutic, nutritional and dietetic visits.
  • Hatha Yoga Group (Y): patients will continue TAU and will additionally attend one weekly Hatha Yoga session.
  • From Feeling to Seeing the Body Group (FSB): patients will continue TAU and will additionally attend one weekly FSB session.

详细描述

Background: Eating Disorders (EDs) are characterized by significant disturbances in eating behaviors and body image, where the body itself becomes a primary medium for the expression of psychological distress. Body image plays a crucial role in both the development and maintenance of EDs. Historically, research has focused on negative body image, with substantial evidence linking body image distortion to long-term outcomes in anorexia nervosa, both during adolescence and adulthood. However, recent research has shifted towards exploring the multidimensional construct of Positive Body Image (PBI) and the integration of body-focused interventions into standard therapeutic protocols. The Embodied Self Model provides a comprehensive framework that supports self-esteem, positive body image, and intuitive eating as protective factors against EDs and related symptoms. According to this model, the core of ED symptoms lies in the relationship an individual has with their own body. This relationship is reflected in how the body is experienced, nurtured, cared for, and accepted-collectively referred to as embodiment. The model offers strategies to reconnect individuals with themselves through the development of Body Appreciation, Body Functionality, Body Image Flexibility, Mindful Attunement, and Self-Compassion. Recent studies have evaluated the effectiveness of embodiment-based interventions, such as yoga, demonstrating their utility in treating EDs and improving positive embodiment outcomes. In this context, an intervention called From Feeling to Seeing the Body (FSB) was developed, which aims to enhance body awareness through sensory, motor, cognitive, and emotional experiences.

Endpoints: The primary aim of this study is to demonstrate that embodiment interventions can improve body image and eating behaviors in patients with Eating Disorders. Primary Endpoint: 1. Dysfunctional eating behaviors and body dissatisfaction, measured by the Thinness Drive, Bulimia, and Body Dissatisfaction subscales of the Eating Disorder Inventory-3 (EDI-3). Each subscale will be scored and reported independently, collected at four time points (T0, T1, T2, and T3). Secondary Endpoint: 2. Embodiment, measured by the Experience of Embodiment Scale (EES), collected at four time points (T0, T1, T2, and T3). Other Endpoints: 3. Interoceptive awareness, measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA). 4. Body appreciation, measured by the Body Appreciation Scale-2 (BAS-2). 5. Functionality appreciation, measured by the Functionality Appreciation Scale (FAS). 6. Mindfulness, measured by the Five Facet Mindfulness Questionnaire (FFMQ). 7. Self-compassion, measured by the Self-Compassion Scale (SCS). 8. Body image perception and representation, measured by the "Mi Disegno" body drawing task. Analysis Method: Each instrument will be scored and reported independently. Endpoints 3-7 will be collected at four time points (T0, T1, T2, and T3); endpoint 8 will be collected at T0 and T3 only.

Methods: This study will involve 54 patients from the Provincial Center for Eating Disorders of Treviso (AULSS2), who are receiving outpatient care and meet the inclusion criteria. Patients will be randomly assigned to one of the following three groups: Control (C), Yoga (Y), and FSB (From Feeling to Seeing the Body).

Procedures: Screening Phase: Eligibility for participation will be assessed based on the inclusion/exclusion criteria before enrollment. Enrollment Procedure: Eligible patients will be invited to participate in the study, and informed consent will be provided. Intervention Assignment: Participants will be randomly assigned to one of the three groups (C, Y, FSB) using a Research Randomizer. Intervention: Each group will participate in an identical number of sessions, with the same structure maintained across all groups.

Data Collection: Self-report questionnaires will be administered at four time points: T0 (pre-treatment), T1 (post-treatment), T2 (one month post-treatment), and T3 (three months post-treatment). Self-Report Questionnaires: The following validated self-report questionnaires will be used to measure the key variables: Negative Body Image and Eating Behaviors: Subscales of Thinness Drive, Bulimia, and Body Dissatisfaction from the Eating Disorder Inventory-3 (EDI-3). Embodiment: Experience of Embodiment Scale (EES). Interoceptive Awareness: Multidimensional Assessment of Interoceptive Awareness (MAIA). Body Appreciation: Body Appreciation Scale-2 (BAS-2). Functionality Appreciation: Functionality Appreciation Scale (FAS). Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ). Self-Compassion: Self-Compassion Scale (SCS). Body Image: "Mi Disegno".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Outpatients receiving treatment at the CPD DNA (Centro Provinciale per i Disturbi della Nutrizione e dell'Alimentazione) in Treviso;
  • Diagnosis of Anorexia Nervosa (AN) and/or Bulimia Nervosa (BN);
  • Body mass index (BMI) ≥ 17 kg/m²;
  • Clinically stable condition during the previous month (i.e., stable weight and no worsening of clinical symptomatology);
  • No planned hospital admissions or discharges within the 3 months following enrollment.

排除标准

  • Sudden worsening of clinical condition;
  • Transition during the treatment phase to a higher level of care (i.e., partial hospitalization, residential treatment, or inpatient admission);
  • Irregular attendance (i.e., participation in less than 80% of the total scheduled sessions);
  • Discharge during the treatment phase;
  • Pregnancy: pregnant women will be excluded, as pregnancy is associated with physiological changes in weight and body shape and may exacerbate body dissatisfaction during the pre- and postpartum periods. Therefore, the exclusion of pregnant women is consistent with the study objectives;
  • Previous continuous yoga practice (i.e., for more than 6 months).

研究组 & 干预措施

Hatha Yoga Group (Y)

Experimental

Patients will continue Treatment as Usual (TAU) and will additionally attend one weekly Hatha Yoga session.

干预措施: Hatha Yoga Group (Y) (Behavioral)

From Feeling to Seeing the Body Group (FSB)

Experimental

Patients will continue Treatment As Usual and will additionally attend one weekly FSB session.

干预措施: From Feeling to Seeing the Body Group (FSB) (Behavioral)

Control Group (C)

Active Comparator

Patients will continue with treatment as usual (TAU) which consists of periodic psychiatric, psychotherapeutic, nutritional and dietetic visits.

干预措施: Control Group (C) (Behavioral)

结局指标

主要结局

Body Dissatisfaction and Dysfunctional Eating Behaviors as Measured by the Eating Disorder Inventory-3 (EDI-3)

时间窗: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).

Change from baseline in dysfunctional eating behaviors and body dissatisfaction, measured by three subscales of the Eating Disorder Inventory-3 (EDI-3): Drive for Thinness (7 items, range 0-28), Bulimia (8 items, range 0-32), and Body Dissatisfaction (9 items, range 0-36). Each subscale is scored and reported independently. Higher scores indicate greater symptom severity. Scores are compared across the Hatha Yoga (Y), From Feeling to Seeing the Body (FSB), and Control (C) groups.

次要结局

  • Embodiment as Measured by the Experience of Embodiment Scale (EES)(Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).)

研究者

发起方
Azienda Ulss 2 Marca Trevigiana
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chiara Fuligno

TNPEE (Neurodevelopmental and Psychomotor Therapist) at Provincial Center for Eating Disorder, Treviso,

Azienda Ulss 2 Marca Trevigiana

研究点 (1)

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