An interventional study of Hatha Yoga Group (Y) and From Feeling to Seeing the Body Group (FSB) in Body Image, Eating Disorders and Anorexia Nervosa, sponsored by Azienda Ulss 2 Marca Trevigiana. Completed at 1 site in Italy. Open to female participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Azienda Ulss 2 Marca Trevigiana · Not applicable, Interventional, and Treatment
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:
Participants will be divided into three groups:
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".
740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.
This study's enrollment of 54 is below the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →Azienda Ulss 2 Marca Trevigiana is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Patients will continue Treatment as Usual (TAU) and will additionally attend one weekly Hatha Yoga session.
Behavioral: Hatha Yoga Group (Y)
Patients will continue Treatment As Usual and will additionally attend one weekly FSB session.
Behavioral: From Feeling to Seeing the Body Group (FSB)
Patients will continue with treatment as usual (TAU) which consists of periodic psychiatric, psychotherapeutic, nutritional and dietetic visits.
Behavioral: Control Group (C)
Hatha Yoga is an ancient Indian discipline aimed at promoting psychophysical well-being through the integration of bodily movement, regulated breathing, and cultivated awareness across different forms of practice. It is suitable for individuals of all ages, levels of physical fitness, and prior experience. Hatha Yoga encompasses a broad range of postures (Asana) and breathing techniques (Pranayama), which can be adapted to various clinical conditions. Each session will follow a standardized structure: 5 minutes of mindfulness practice and mantra recitation; 25 minutes of Asana practice; 10 minutes of Pranayama; 18 minutes of Yoga Nidra; and 2 minutes of concluding mantra recitation. Throughout the intervention period, different practices will be introduced progressively, in accordance with participants' increasing familiarity with yoga. For research purposes, the sessions delivered to the two groups will be identical.
Thirteen weekly 60-minute sessions will be conducted. The first session will be delivered individually, and the subsequent sessions will take place in pairs. One introductory session focused on the concept of body image and the experiential implementation of the silhouette task (body figure drawing). FEELING - The initial sessions involve predominantly passive experiences (e.g., massage with balls and fabrics), whereas the subsequent sessions focus on active experiential practices (e.g., movement with fabrics, exploration of muscle tone, and movement under blindfolded conditions). SEEING - The second phase of the intervention involves the gradual experiential exploration of one's body image, beginning with shadow-based activities and distorted mirrors, and culminating in structured mirror exposure.
The integrated multidisciplinary standard intervention, SSCM (Specialist Supportive Clinical Management), includes periodic psychiatric, psychotherapeutic, nutritional, and dietetic consultations. Specialist Supportive Clinical Management (SSCM) combines clinical management and supportive psychotherapy within individual sessions, primarily focusing on the normalization of eating behaviors and weight restoration. It provides specialized psychoeducation regarding the core features of eating disorders and addresses additional personal difficulties identified by the patient. Treatment as usual (TAU), which is also provided to participants in the other two intervention groups (Y and FSB), consists of periodic individualized sessions tailored to the patient's clinical needs. Each patient will have access to outpatient specialist consultations with the following professionals: Psychiatrist, Medical nutritionist, Psychologist-psychotherapist, Dietitian.
Body Dissatisfaction and Dysfunctional Eating Behaviors as Measured by the Eating Disorder Inventory-3 (EDI-3)
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.
Time frame: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Embodiment as Measured by the Experience of Embodiment Scale (EES)
Change from baseline in embodiment, measured by the Experience of Embodiment Scale (EES; 34 items, range 34-170). Higher scores indicate a more positive experience of embodiment. Scores are compared across the Hatha Yoga (Y), From Feeling to Seeing the Body (FSB), and Control (C) groups.
Time frame: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Interoceptive Awareness as Measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Change from baseline in interoceptive awareness, measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA; 37 items across 8 subscales, each scored 0-5). Higher scores indicate greater adaptive interoceptive awareness. Subscales are scored and reported independently. Scores are compared across the Hatha Yoga (Y), From Feeling to Seeing the Body (FSB), and Control (C) groups.
Time frame: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Body Appreciation as Measured by the Body Appreciation Scale-2 (BAS-2)
Change from baseline in body appreciation, measured by the Body Appreciation Scale-2 (BAS-2; 10 items, range 1-5, mean score). Higher scores indicate greater body appreciation. Scores are compared across the Hatha Yoga (Y), From Feeling to Seeing the Body (FSB) and Control (C) groups.
Time frame: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Functionality Appreciation as Measured by the Functionality Appreciation Scale (FAS)
Change from baseline in functionality appreciation, measured by the Functionality Appreciation Scale (FAS; 7 items, range 0-28). Higher scores indicate greater appreciation of body functionality. Scores are compared across the Hatha Yoga (Y), From Feeling to Seeing the Body (FSB), and Control (C) groups.
Time frame: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Mindfulness as Measured by the Five Facet Mindfulness Questionnaire (FFMQ)
Change from baseline in mindfulness, measured by the Five Facet Mindfulness Questionnaire (FFMQ; 39 items across 5 subscales, range 39-195). Higher scores indicate greater dispositional mindfulness. Subscales are scored and reported independently. Scores are compared across the Hatha Yoga (Y), From Feeling to Seeing the Body (FSB), and Control (C) groups.
Time frame: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Self-Compassion as Measured by the Self-Compassion Scale (SCS)
Change from baseline in self-compassion, measured by the Self-Compassion Scale (SCS; 26 items across 6 subscales, range 26-130). Higher scores indicate greater self-compassion. Subscales are scored and reported independently. Scores are compared across the Hatha Yoga (Y), From Feeling to Seeing the Body (FSB), and Control (C) groups.
Time frame: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Body Image Perception and Representation as Measured by the "Mi Disegno" Body Drawing Task
Change from baseline in body image perception and representation, measured by the "Mi Disegno" body drawing task (Confalonieri, 2011; total score range 0-27, across three domains: Formal Level, Details, and Sexual Characterization, each scored 0-9). Higher scores indicate a more accurate and articulated body representation. Scores are compared across the Hatha Yoga (Y), From Feeling to Seeing the Body (FSB), and Control (C) groups.
Time frame: Baseline (T0) and Week 26 (T3, 3-month follow-up).
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Plan to share: No — A data sharing plan will be developed by the research team after the publication of the first manuscript.
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Azienda Ulss 2 Marca Trevigiana