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.
Phase: NA
Conditions: Body Image, Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
Sponsor: Azienda Ulss 2 Marca Trevigiana

 
 
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MENTAL HEALTH DEPARTMENT  
UOC Psychiatry of Treviso  
UOS Nutrition and Eating Disorders – Treviso 
 
 
PROTOCOL 
NON-PHARMACOLOGICAL INTERVENTIONAL STUDY 
 
 
Study Title: 
 
Parallel randomised controlled pilot study on 
the efficacy of Hatha Yoga and From Feeling 
to Seeing the Body – Embodied Experience 
Intervention for body image (FSB) in the 
treatment of body image in patients with 
eating disorders. 
 
Protocol Version: 
Version No. 2.1 
 
Date: 
14/03/2025 
 
Funding: 
No funding is planned 
 
Sponsor: 
 
AULSS 2 Marca Trevigiana 
 
Coordinating Centre: 
U.O.S. Eating Disorders, U.O.C. Psychiatry – 
Treviso District 
 
Principal Investigator: 
Fuligno 
Chiara, 
TNPEE, 
U.O.S. 
Eating 
Disorders TV AULSS 2. 
 
Other Investigators at the 
Coordinating Centre: 
Fontana Francesca, Psychiatrist, U.O.S. 
Eating Disorders TV AULSS 2. 
 
 
 
 
 
 
 
 

 
 
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PROTOCOL APPROVAL 
 
The Investigators: 
● approve the present Protocol; 
● declare that the study will be conducted in accordance with what is reported in the present 
protocol. 
 
 

 
 
 
 
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Background and Rationale 
 
In Eating Disorders (ED) the body and its representation is the field in which the individual's distress is 
expressed. The DSM-5 (APA, 2013) identifies as a diagnostic criterion for Anorexia Nervosa (AN) and Bulimia 
Nervosa (BN) a "disturbance in the way in which one's body weight or shape is experienced, and undue 
influence of body weight or shape on self-evaluation".1 
Body image, which refers to the mental representation people have of their own body, therefore plays a 
central role in the development and maintenance of EDs. To date, research in this area has primarily focused 
on negative body image, finding evidence of an association between perceptual distortion of body image and 
the long-term outcome of AN, both in adolescence2 and in adulthood. A systematic review of the literature 
on body image disturbance in adolescents with AN and BN found that, compared to individuals without EDs, 
those with AN show lower accuracy in estimating their own body dimensions, higher levels of body 
dissatisfaction, greater negative emotions and more negative thoughts towards their own body, as well as 
greater body checking behaviours (i.e., checking the shape and dimensions of their own body).3 Building on 
these studies, recent research is investigating the different levels of bodily experience in this population, 
making evident the strong interconnection between the sensory, motor, cognitive and emotional 
components. 
In addition to studies investigating the concept of negative body image, a line of research on positive body 
image is developing. Positive body image is a multidimensional construct involving multiple aspects, including 
body and functionality appreciation, body acceptance, a broad conceptualisation of beauty, inner positivity 
and awareness of body needs.4 Recent studies suggest a close association between positive body image and 
remission from EDs. The recent study by Torres, Vieira et al.5 examined the main indices of positive body 
image in AN, exploring their association with emotion regulation and well-being, finding that positive body 
image significantly predicted emotion regulation and psychological well-being in people with AN. 
Consequently, therapeutic pathways that promote a positive body image are fundamental to the treatment 
of AN. 
A systematic review of the literature6 revealed that body-oriented therapeutic programmes promoting a 
positive body image are effective in reducing risk factors and strengthening protective factors in patients 
with EDs, and that the inclusion of body-oriented therapy in standard therapeutic practice could substantially 
 
1 Diagnostic and statistical manual of mental disorders. Milan: Raffaello Cortina, 2014. 
2 Boehm, I., Finke, B., Tam, F.I. et al. Effects of perceptual body image distortion and early weight gain on long-term 
outcome of adolescent anorexia nervosa. Eur Child Adolesc Psychiatry 25, 1319–1326 (2016) 
3 Sattler, F.A., Eickmeyer, S. & Eisenkolb, J. Body image disturbance in children and adolescents with anorexia nervosa 
and bulimia nervosa: a systematic review. Eat Weight Disord 25, 857–865 (2020) 
4 Tylka, T.L.; Wood-Barcalow, N.L. What is and what is not positive body image? Conceptual foundations and 
construct definition. Body Image 2015, 14, 118–129. 
5 Torres S, Vieira AI, Vieira FM, Miller KM, Guerra MP, Lencastre L, Reis AC, Timóteo S, Nunes P, Barbosa MR. A 
Comprehensive Study of Positive Body Image as a Predictor of Psychological Well-Being in Anorexia Nervosa. 
Nutrients. 2024 Jun 6;16(11):1787. doi: 10.3390/nu16111787. 
6 Korsak, Emilia. (2022). Body-oriented therapy in the prevention of eating disorders. A systematic review. Przegląd 
Psychologiczny. 65. 177-195. 

 
 
 
 
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reduce ED symptoms. The studies analysed involved the following methods and therapeutic protocols: body 
awareness, yoga, dance movement therapy, Feldenkrais method, body perception treatment protocol, basic 
body awareness therapy, relaxation techniques and aerobic exercise. The studies examined indicate that the 
integration of body-oriented methods into standard therapeutic programmes (cognitive-behavioural therapy 
and/or pharmacotherapy) or the use of body-oriented therapy as an autonomous therapeutic method can 
substantially reduce ED symptoms. 
In line with this direction is research based on the Embodied Self Model7. The Embodied Self Model provides 
a comprehensive framework supporting positive body image and its associated characteristics (e.g., intuitive 
eating) as protective factors for EDs and related symptoms. According to this model, at the centre of ED 
symptoms is the relationship an individual has with their own body, reflected in the way the body is 
experienced, nourished, cared for and accepted. EDs therefore involve the loss of an embodied sense of self 
(i.e., embodiment),8 which leads to a lack of attunement and a disconnection from the signals of one's own 
body. The model offers strategies for reconnecting with oneself, through the development of Body 
Appreciation, Body Functionality, Body Image Flexibility, Mindful Attunement, Self-Compassion, and Intuitive 
Eating. 
Body Appreciation – acceptance, a favourable attitude and respect towards one's own body – is the most 
widely studied aspect of positive body image. Several meta-analyses have shown that body appreciation is 
inversely associated with numerous indices of dysfunctional eating (dietary restriction) and body image 
disturbance (internalisation of the thinness ideal, body surveillance, sociocultural pressures) and general 
psychopathology (depression, anxiety). Body appreciation has been positively associated with several well-
being constructs (self-esteem, self-compassion, sexual satisfaction). In particular, the associations found 
remained significant even after controlling for the influence of negative body image.9 
Body Functionality describes everything the body is capable of doing, across different domains (e.g., physical 
activities, physical sensations, creative activities). Research has demonstrated that Body Functionality is a 
key component of positive body image and well-being, especially when individuals appreciate their body's 
abilities and view their body's functionality in a holistic and integrated manner.10 
Body Image Flexibility is the ability to accept positive and negative bodily experiences, to openly experience 
thoughts or feelings about the body without acting on them or seeking to change them. Body image flexibility 
has been positively associated with constructs of positive psychology and is linked to mental health indices.11 
Mindful Attunement is the integration of awareness and healthy, sustainable connection with internal and 
external experiences of the self, guiding intentional thinking and behaviours in support of well-being.12 
 
7 Cook-Cottone, C. (2006), The attuned representation model for the primary prevention of eating disorders: An 
overview for school psychologists. Psychol. Schs., 43: 223-230. 
8 Catherine P. Cook-Cottone, Incorporating positive body image into the treatment of eating disorders: A model for 
attunement and mindful self-care, Body Image, Volume 14, 2015, Pages 158-167, ISSN 1740-1445. 
9 Linardon J, McClure Z, Tylka TL, Fuller-Tyszkiewicz M. Body appreciation and its psychological correlates: A 
systematic review and meta-analysis. Body Image. 2022 Sep;42:287-296. 
10 Alleva JM, Tylka TL. Body functionality: A review of the literature. Body Image. 2021 Mar;36:149-171. 
11 Linardon J, Anderson C, Messer M, Rodgers RF, Fuller-Tyszkiewicz M. Body image flexibility and its correlates: A 
meta-analysis. Body Image. 2021 Jun;37:188-203. 
12 Tylka, Tracy L., Niva Piran, and Catherine P. Cook-Cottone, 'Mindful Attunement', in Tracy L. Tylka (ed.), Handbook 
of Positive Body Image and Embodiment (New York, 2019). 

 
 
 
 
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Self-Compassion is kindness and understanding towards oneself, rather than using harsh self-criticism and 
severe judgment; considering one's own experience as part of a broader human experience rather than as a 
separate and isolated one; holding one's painful thoughts and feelings in balanced awareness rather than 
over-identifying with them. Self-compassion is linked to positive mental health outcomes such as lower 
depression and anxiety and greater life satisfaction.13 
Intuitive Eating is eating based on physiological hunger and satiety signals rather than situational and 
emotional cues, and is associated with psychological well-being.14 
A recent network analysis study (Cerea et al., 2024) considered both the dimensions of ED symptoms (e.g., 
drive for thinness, bulimic symptoms and body dissatisfaction) and protective factors linked to positive body 
image (e.g., body and functionality appreciation, intuitive eating and self-esteem), to shed light on how these 
factors are correlated. The network analysis showed that some dimensions of positive body image (e.g., body 
and functionality appreciation and specific dimensions of intuitive eating) are relevant protective factors with 
respect to ED symptoms.15 
Therefore, the literature suggests incorporating the promotion of a positive body image into psychological 
interventions for EDs, and making psychological interventions more 'embodied'. 
In the field of research on interventions following the embodiment model, studies exist on yoga practice in 
the treatment of EDs. The results of a meta-analysis conducted by Borden and Cook-Cottone in 2020 
indicated that yoga interventions can be an effective approach to support the prevention and treatment of 
EDs.16 Yoga practice has been associated with various indices of positive embodiment in correlational and 
intervention studies. However, systematic and theoretically grounded models are lacking that describe in 
detail the specific mechanisms by which yoga supports positive embodiment.  
Results regarding the efficacy of yoga in the treatment of EDs and body image are still limited, albeit with 
promising findings, and are generally characterised by a not always clear articulation of the theoretical 
concepts guiding the design of the intervention programme. Another aspect highlighted by O'Brien, Evans et 
al. is the need to clarify which component of the intervention (yoga with or without psychological 
approaches) contributes to the outcomes.17 
Also following the embodiment model, the treatment "From Feeling to Seeing the Body" (FSB) was developed 
– a body image intervention based on the embodied experience of the body. FSB comprises experiences 
aimed at fostering greater body awareness at the sensory, motor, cognitive and emotional levels. The 
pathway was developed starting from the experimentation of the body through mindful listening to bodily 
sensations (interoceptive, proprioceptive and tactile) to arrive at "re-seeing" the body by reconstructing an 
 
13 Neff, Kristin. (2003). The Development and Validation of a Scale to Measure Self-Compassion. Self and Identity. 2. 
223-250. 
14 Tylka, TL (2006). Development and psychometric evaluation of a measure of intuitive eating. Journal of Counseling 
Psychology, 53(2), 226–240. 
15 Silvia Cerea, Sara Iannattone, Paolo Mancin, Gioia Bottesi, Igor Marchetti, Eating disorder symptom dimensions and 
protective factors: A structural network analysis study, Appetite, Volume 197, 2024. 
16 Ashlye Borden & Catherine Cook-Cottone (2020) Yoga and eating disorder prevention and treatment: A 
comprehensive review and meta-analysis, Eating Disorders, 28:4,400-437. 
17 O'Brien J, Evans S, McIver S, O'Shea M. A scoping review of integrated yoga and psychological approaches for the 
treatment of eating disorders. J Eat Disord. 2023 Sep 8;11(1):152. 

 
 
 
 
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image based on the embodied experience. In this pathway, the experience of touch and shadow are very 
important steps, structured on the basis of studies conducted in this area. Recent research indeed suggests 
that anomalies in the perception of touch may contribute to the pathological mechanisms of AN. A 2018 
study by Davidovic, Starck et al. investigated through fMRI possible cortical anomalies in patients with AN in 
the presence of gentle touch. The results suggest that abnormal functioning of the dorsal striatum could 
influence the evaluation of pleasurable tactile stimuli and that abnormal functioning of the lateral occipital 
cortex could be correlated with a distorted perception of body image.18 
Another study investigated the ability to distinguish between self-generated and other-generated touch, and 
how this contributes to the perception of body boundaries and, more generally, to the distinction between 
self and other. Both of these abilities are found to be altered in AN. The inability to attenuate self-touch could 
be correlated with altered predictions about one's own body and a reduced perception of body boundaries.19 
The perceptual component of body image has also been investigated through studies related to shadows. 
Pavani and Galfano demonstrate that self-attributed body shadows draw attention to the part of the body 
they refer to, rather than to the position they occupy; therefore, recognising oneself as the owner of a 
shadow influences the distribution of tactile attention. Body shadows orient attention towards the body part 
that projects the shadow itself.20 Being able to orient attention to one's own body through touch and the 
mediation of the shadow exposes patients to a new way of coming into contact with their own body, which 
allows them to approach their own image in a more embodied manner – an important step for these patients 
in helping them to expose themselves to the sight of their own body (e.g., in the mirror). 
 
 
Study Objectives 
Primary Objective 
To investigate the efficacy of two psychological interventions for body image and eating behaviours in 
patients with EDs. The two intervention groups are: 1) yoga practice and 2) From Feeling to Seeing the Body 
(FSB); these interventions will be compared with a control group (i.e., treatment as usual). 
Specifically, we are interested in investigating the efficacy of the interventions on two primary outcomes: 1) 
eating behaviours and 2) body dissatisfaction. 
The three groups (i.e., yoga practice, FSB, control) will share a common integrated multidisciplinary baseline 
treatment – SSCM (Specialist Supportive Clinical Management) at the same level of intensity, comprising 
periodic psychiatric, psychotherapeutic, nutritional and dietetic visits. 
 
18 Davidovic M, Karjalainen L, Starck G, Wentz E, Björnsdotter M, Olausson H. Abnormal brain processing of gentle 
touch in anorexia nervosa. Psychiatry Res Neuroimaging. 2018 Nov 30;281:53-60. 
19 Frost-Karlsson M, Capusan AJ, Perini I, Olausson H, Zetterqvist M, Gustafsson PA, Boehme R. Neural processing of 
self-touch and other-touch in anorexia nervosa and autism spectrum condition. Neuroimage Clin. 2022;36:103264. 
20 Pavani F, Galfano G. Self-attributed body-shadows modulate tactile attention. Cognition. 2007 Jul;104(1):73-88. 

 
 
 
 
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Secondary Objective 
To investigate the psychological mechanisms underlying the efficacy of the two psychological interventions 
(i.e., Yoga and FSB) for body image and eating behaviours. The possible psychological mechanisms involved, 
in accordance with the Embodied Self Model, which we consider to be at the basis of the interventions' 
efficacy, 
are: 
embodiment, 
interoceptive 
awareness, 
body 
and 
functionality 
appreciation, 
mindfulness/awareness and self-compassion. 
Study Design 
Experimental non-pharmacological interventional study, single-centre randomised controlled, with non-
profit purposes. 
The study will involve patients attending the Provincial Centre for Nutrition and Eating Disorders of Treviso 
(Aulss2) on an outpatient basis, who meet the inclusion criteria. 
Three groups are planned: 
• 
Control Group (C), which will follow the treatment-as-usual (Specialist Supportive Clinical 
Management; SSCM) comprising periodic psychiatric, psychotherapeutic, nutritional and dietetic 
visits. 
• 
Yoga Group (Y), which will participate in treatment-as-usual (SSCM) + a weekly group Hatha Yoga 
session. 
• 
From Feeling to Seeing the Body Group (FSB), which will follow treatment-as-usual (SSCM) + a 
weekly paired FSB session. 
Patients will be randomly assigned to the groups (C, Y, FSB) using the Research Randomizer software. 
Each group/pair will participate in the same number of sessions and will follow the same type of intervention 
as the other groups: the session structure will remain identical across the different subgroups. 
Questionnaire administration (described in the Instruments section) will take place for all 3 groups (CG, Y, 
FSB) at four time-points: T0 (before the start of treatment), T1 (at the end of treatment), T2 (one month after 
the end of treatment), T3 (three months after the end of treatment). 

 
 
 
 
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Study Duration 
The study includes the following phases with indicative implementation periods: 
● Selection, enrolment and questionnaire administration at T0 (December 2024 – February 2025); 
● Implementation of Yoga and FSB interventions and questionnaire administration at T1 (March – June 
2025); 
● Follow-up including questionnaire administration at T2 (July 2025) and T3 (September 2025); 
● Data analysis and completion (October – November 2025). 
Study Population 
Setting: U.O.S. Provincial Centre for Nutrition and Eating Disorders AULSS2 Treviso, U.O.C. CSM Treviso. 
Sample size: A sample of 60 patients has been defined based on the number of users attending the Provincial 
Centre for Nutrition and Eating Disorders AULSS2 Treviso. 
 
Eligibility Criteria 
Inclusion Criteria 
● Female gender 
● Patients under outpatient care at the CPD DNA of Treviso; 
● Diagnosis of Anorexia Nervosa (AN) and/or Bulimia Nervosa (BN); 
● Age between 16 and 25 years; 
● Body Mass Index (BMI) ≥ 17 kg/m²; 
● Clinically stable condition in the past month (i.e., stable weight, absence of worsening in clinical 
symptoms); 
● No hospitalisations or discharges planned within 3 months of enrolment. 
Exclusion Criteria 
● Sudden worsening of the clinical condition; 
● Transition to a higher intensity intervention (semi-residential, residential, hospitalisation) during 
the treatment phase; 
● Discontinuous treatment attendance (participation in less than 80% of total sessions); 
● Discharge during the treatment phase; 
● Pregnancy: Pregnant women are excluded because pregnancy alters body weight and body shape 
and may exacerbate body dissatisfaction during the pre- and postpartum periods.21 The exclusion 
of pregnant women is therefore related to the objectives of the study. 
 
21 Skouteris H, Carr R, Wertheim EH, Paxton SJ, Duncombe D. A prospective study of factors that lead to body 
dissatisfaction during pregnancy. Body Image. 2005; 2:347–61. 

 
 
 
 
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● Previous continuous yoga practice (i.e., for more than 6 months). 
 
Study Procedures 
Study Timeline 
The study timeline proceeds from initial identification of the sample, through T0 baseline assessment, 
treatment phases for all groups, T1 post-treatment assessment, T2 (1-month follow-up) and T3 (3-month 
follow-up) assessments, culminating in data analysis and study conclusions. 
 
Sample Size 
Sample composed of 60 patients (sample size defined based on the available user population attending the 
Provincial Centre for Nutrition and Eating Disorders AULSS2 Treviso). 
Screening Phase 
Before enrolment, eligibility for participation is assessed based on the inclusion/exclusion criteria for the 
study. 
Eligibility and Randomisation 
Enrolment Procedure 
Participation in the study will be proposed to patients who: 
● Have been followed by the Provincial DNA Centre of Treviso for at least one month and have 
therefore completed the diagnostic-evaluative pathway; 

 
 
 
 
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● Have already started the integrated multidisciplinary baseline SSCM (Specialist Supportive Clinical 
Management) intervention, which includes periodic psychiatric, psychotherapeutic, nutritional and 
dietetic visits; 
● Meet the eligibility criteria (inclusion and exclusion). 
Patients deemed eligible for enrolment will be offered participation in the study and the informed consent 
form will be shared. 
Intervention Assignment 
Block randomisation will be used to assign participants to the groups, to ensure that the experimental groups 
(the two intervention groups) and the control group have a similar number of participants. 
The allocation sequence will be generated using randomisation software (i.e., Research Randomizer). The 
allocation ratio will be 1:1:1, ensuring that the two experimental groups and the control group have the same 
number of participants. 
The study has been organised in a manner that maintains independence between the different phases of the 
process.  
Participants will be recruited by staff of the U.O.S. Provincial Centre for Nutrition and Eating Disorders AULSS2 
Treviso, U.O.C. CSM Treviso. 
 
Treatment 
Due to the different characteristics of the two interventions and the implementation methods, it will be 
necessary to divide patients into subgroups: 
● Group Y will subsequently be divided into 2 groups of 10 patients. 
● Group FSB will subsequently be divided into 10 pairs of patients. 
YOGA Intervention 
13 sessions (one per week) of group Hatha Yoga, each lasting 60 minutes. 
The groups will be led by the principal investigator, Dr. Chiara Fuligno, a certified Hatha Yoga teacher for 
beginners. 
Hatha Yoga is an ancient Indian doctrine that aims at the person's psychophysical well-being and integrates 
body movement with the flow of breath and awareness through different types of practice. Hatha Yoga is 
suitable for people of all ages, fitness levels and experience. It provides a wide range of movements (Asana) 
and breathing techniques (Pranayama) adaptable to any clinical condition. 
Each session will have the following structure: 5 minutes of mindfulness practice and Mantra22, 25 minutes 
 
22 Mantra is a Sanskrit word derived from two roots: man, meaning 'mind' or 'to think', and trai, meaning 'to protect', 
'to liberate from' or 'instrument'. Therefore, mantras are instruments for liberating the mind. It is one of the most 
commonly used aids in meditation. 

 
 
 
 
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of Asana23, 10 minutes of Pranayama24, 18 minutes of Yoga Nidrā25, 2 minutes of final mantra. 
The sessions involve different practices over the course of the weeks according to progressive familiarisation 
with yoga. For the purposes of the research, the sessions of the two groups will be identical. 
FSB Intervention 
13 sessions (one per week) of 60 minutes of FSB (From Feeling to Seeing the Body – Embodied experience 
intervention for body image). Session 0 will be individual, while the subsequent 12 will be conducted in pairs. 
The groups will be led by the principal investigator, Dr. Chiara Fuligno, TNPEE, who designed and structured 
the FSB intervention based on bodily experimentation. 
SESSION 0 (individual) 
The intervention includes an individual preparatory session for the contents of the intervention, in which the 
body outline activity will be experienced (drawing of the body figure) with a subsequent mindful-oriented 
reflection to introduce the complexity of the concept of embodied experience of body image according to 
the Embodied Self Model6. 
FEELING/SENSING 
SESSION 1 (beginning of the paired pathway) – Mutual experimentation of passive contact with balls of 
different sizes, weights and textures, with the use of music. Brief listening and mindfulness practice. Graphic 
representation. Mindful-Oriented reflection on the experience. 
SESSION 2 – Mutual experimentation of passive contact with fabrics of different sizes, weights and textures, 
with the use of music. Brief listening and mindfulness practice. Graphic representation. Mindful-Oriented 
reflection on the experience. 
SESSION 3 – Active tactile and proprioceptive experimentation through movement with elastic fabrics of 
different sizes, weights and textures, with the use of music. Brief listening and mindfulness practice. Graphic 
representation. Mindful-Oriented reflection on the experience. 
SESSION 4 – Experimentation of one's own muscle tone and contact with the other through voluntary 
contraction/relaxation exercises, bodily experimentations of pushing, falling and wrestling on the ground. 
Brief listening and mindfulness practice. Graphic representation. Mindful-Oriented reflection on the 
experience. 
SESSION 5 – Active motor and proprioceptive experimentation through spontaneous movement in space 
with the use of music and a blindfold/eyes closed. Brief listening and mindfulness practice. Graphic 
representation. Mindful-Oriented reflection on the experience. 
SESSION 6 – Active motor and proprioceptive experimentation through spontaneous movement in space 
 
23 Postures used in Yoga practice that aim to trigger specific beneficial physiological processes. 
24 'Prana' means breath, 'Ayama' means extension, control. The word Pranayama therefore means the extension of 
breath and its control. Pranayama comprises various techniques to make the respiratory organs move and expand 
intentionally, rhythmically, and to regulate the flow of energy in the body 
25 Yoga Nidrā is a meditation practised lying down. In Sanskrit, the word 'nidra' means 'sleep'. During the practice a 
state of deep relaxation is reached during which, even though relaxed, one is totally awake, receptive and aware of 
one's own sensations, emotions and thoughts. 
 

 
 
 
 
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with the use of music and a blindfold/eyes closed. Interaction with the other is encouraged. Brief listening 
and mindfulness practice. Graphic representation. Mindful-Oriented reflection on the experience. 
SEEING/VIEWING 
SESSION 7 – Bodily experimentation of the shadow through the projection of images and music inspired by 
the following contrasts (light/heavy, rigid/flexible). Brief listening and mindfulness practice. Graphic 
representation. Mindful-Oriented reflection on the experience. 
SESSION 8 – Bodily experimentation of one's own shadow through the projection of slides with progressively 
wider spaces of light, with the use of music. Brief listening and mindfulness practice. Graphic representation. 
Mindful-Oriented reflection on the experience. 
SESSION 9 – Bodily experimentation of one's own image reflected in progressively more numerous distorting 
mirrors that the patient will decide where to position. Brief listening and mindfulness practice. Graphic 
representation. Mindful-Oriented reflection on the experience. 
SESSION 10 – Bodily experimentation, with the use of music, of one's own image in movement reflected in a 
large flexible mirror moved by both the patient and their partner. Brief listening and mindfulness practice. 
Graphic representation. Mindful-Oriented reflection on the experience. 
SESSION 11 – Guided mirror exposure with spontaneous and non-judgmental description. Brief listening and 
mindfulness practice. Graphic representation. Mindful-Oriented reflection on the experience. 
SESSION 12 – Guided mirror exposure focused on body functionality and cognitive dissonance. Brief listening 
and mindfulness practice. Graphic representation. Mindful-Oriented reflection on the experience. 
As-usual Intervention (SSCM) 
The integrated multidisciplinary baseline SSCM (Specialist Supportive Clinical Management) intervention 
includes periodic psychiatric, psychotherapeutic, nutritional and dietetic visits. 
Specialist Supportive Clinical Management (SSCM) combines clinical management and supportive 
psychotherapy within individual sessions, focusing on normalising eating and on weight restoration. It 
provides specialist psychoeducation on the key characteristics of the eating disorder and addresses other 
personal problems identified by the patient. 
The treatment-as-usual, present in the other two intervention groups (Y and FSB) as well, includes periodic 
individual sessions personalised according to the patient's clinical needs. Each patient will have access to 
outpatient specialist visits with the following professionals: 
● Psychiatrist: psycho-clinical consultation, monitoring of any pharmacological therapy. Frequency: 
from once a month to once every two months. 
● Nutritionist: monitoring of clinical condition, any prescription of instrumental tests and 
medications. Frequency: once every two months. 
● Psychologist-psychotherapist: individual psychotherapeutic consultation. Frequency: from once a 
week to once every two weeks. 
● Dietitian: personalised dietary guidance, any management of oral nutritional supplements, 
monitoring of the dietary plan, nutritional education. Frequency: from once a week to once every 
two weeks. 

 
 
 
 
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Tests 
Below are the questionnaires used and the administration time-points planned by the project timeline. 
INSTRUMENTS: 
Negative body image and eating behaviours: Drive for Thinness, Bulimia and Body Dissatisfaction subscales 
of the Eating Disorder Inventory-3 (EDI-3; Garner, 2004; Italian version by Giannini, Pannocchia, Dalla Grave, 
Muratori & Viglione, 2008): subscales investigating the presence of dietary restriction behaviours, binge 
eating and the presence of dissatisfaction with one's body shape and weight. 
Reference: Giannini, M., Pannocchia, L., Dalle Grave, R., & Muratori, F. (2008). Italian adaptation of the EDI-
3. Eating Disorder Inventory-3. Giunti OS: Organizzazioni Speciali 
Embodiment: Experience of Embodiment Scale (EES; Piran, Teall, & Counsell, 2020; Italian version by Cerea 
et al., in preparation): questionnaire investigating the experience of living in one's own body. 
Reference: Piran N, Teall TL, Counsell A. The experience of embodiment scale: Development and psychometric 
evaluation. Body Image. 2020 Sep;34:117-134. 
Interoceptive awareness: Multidimensional Assessment of Interoceptive Awareness (MAIA; Mehling et al., 
2012; Italian version by Calì et al., 2015): instrument investigating interoceptive awareness. 
Reference: Calì, G., Ambrosini, E., Picconi, L., Mehling, W. E., & Committeri, G. (2015). Investigating the 
relationship between interoceptive accuracy, interoceptive awareness, and emotional susceptibility. Frontiers 
in psychology, 6, 1202. 
Body Appreciation: Body Appreciation Scale-2 (BAS-2; Tylka & Wood-Barcalow, 2015): self-report 
questionnaire investigating love towards one's own body. 
Reference: Casale, S., Prostamo, A., Giovannetti, S., & Fioravanti, G. (2021). Translation and validation of an 
Italian version of the Body Appreciation Scale-2. Body Image, 37, 1–5. 
Functionality Appreciation: Functionality Appreciation Scale (FAS; Alleva, Tylka & Van Diest, 2017): self-report 
questionnaire investigating the individual's appreciation of their body's functionality. 
Reference: Cerea, S., Todd, J., Ghisi, M., Mancin, P., & Swami, V. (2021). Psychometric properties of an Italian 
translation of the Functionality Appreciation Scale (FAS). Body Image, 38, 210–218. 
Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ; Baer et al. 2006): self-report questionnaire 
investigating mindfulness across five dimensions (Observing, Describing, Acting with Awareness, Non-judging 
and Non-reacting). 
Reference: Giovannini, C., Giromini, L., Bonalume, L., Tagini, A., Lang, M., Amadei, G. (2014). The Italian Five 
Facet Mindfulness Questionnaire: A Contribution to its Validity and Reliability. Journal Of Psychopathology 
And Behavioral Assessment, 36(3), 415-423. 
Self-compassion: Self-Compassion Scale (SCS; Neff, K. D. 2003): self-report questionnaire investigating the 
concept of self-compassion across five dimensions (self-kindness, self-criticism, common humanity, isolation, 
awareness, over-identification). 
Reference: Veneziani, C. A., Fuochi, G., & Voci, A. (2017). Self-compassion as a healthy attitude toward the 
self: Factorial and construct validity in an Italian sample. Personality and Individual Differences, 119, 60-68. 
Body image: Mi disegno (Confalonieri E. 2011): instrument for the evaluation of body image in adolescence 

 
 
 
 
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through graphic representation of one's own body. 
Reference: Confalonieri, Emanuela. (2011). "MI DISEGNO" A tool for the evaluation of body image in 
adolescence. 
TIME-POINTS: 
All questionnaires will be administered at the 4 time-points. The "MI DISEGNO" instrument will be 
administered only at T0 and T1. 
T0: after enrolment and before the start of the intervention 
T1: at the conclusion of the intervention 
T2: 1 month after the conclusion of the intervention 
T3: 3 months after the conclusion of the intervention 
Expected time for administration of the questionnaire battery: maximum 60 minutes. 
Follow-up 
The Follow-up involves the administration of questionnaires 1 month after the conclusion of treatment (T2) 
and 3 months after the conclusion of treatment (T3) for all 3 groups. 
Benefit/Risk Assessment for the Population 
No risks are anticipated for the population. The Hatha Yoga and FSB interventions do not entail specific risks. 
Presumed direct benefits: improved perception of body image and relationship with one's own body, and 
improved eating behaviours. 
Possible indirect benefits: improvement of the constructs of embodiment, interoceptive awareness, body 
and functionality appreciation, mindfulness/awareness and self-compassion. 
Subject Withdrawal and Intervention Modifications 
The intervention will be suspended in the event of worsening of the clinical condition and/or the need for an 
increase in the intensity of the intervention (semi-residential, residential, hospital admission). 
Withdrawal of participant consent from the study involves suspension of treatment. 
A possible withdrawal of 10 out of 60 patients is anticipated. 
Early Termination or Study Suspension 
In the event of unforeseen circumstances that may prevent the intervention from being carried out as 
described above, the sponsor may interrupt the study at any time and promptly notify the investigators and 
the ethics committee. Patients will continue to be followed according to normal clinical practice. 
Definition of Study Completion 
The study will be concluded for the individual patient following the 3-month follow-up after the conclusion 
of treatment (T3), with the final completion of the self-report questionnaires. 
 

 
 
 
 
Pag. 16 a 21 
Study Endpoints 
To demonstrate that bottom-up interventions improve body image and eating behaviours in patients with 
Eating Disorder. 
Primary Endpoint 
Investigation of the efficacy of the Hatha Yoga and FSB interventions. 
MEASURED VARIABLES: negative body image and dysfunctional eating behaviours 
ANALYSIS METHOD: Measurement of the constructs with the following self-report instruments, collected at 
4 different time-points of the study (T0, T1, T2 and T3). 
AGGREGATION METHODS: Data will be processed in an aggregate manner, considering means and standard 
deviations. 
Secondary Endpoint 
Investigation of the psychological mechanisms involved in the efficacy of the Hatha Yoga and FSB 
interventions. 
MEASURED VARIABLES: embodiment, body and functionality appreciation, interoceptive awareness, 
mindfulness/awareness and self-compassion. 
ANALYSIS: Measurement of the constructs with the following self-report instruments, collected at 4 different 
time-points of the study (T0, T1, T2 and T3). The "MI DISEGNO" instrument will be administered only at T0 
and T1. 
Blinding (Masking) 
The person responsible for randomisation and data analysis will use an automated system (i.e., Research 
Randomizer) to generate the group allocation sequence. Once the allocation sequence has been created, it 
will be concealed through anonymous codes that associate participants with intervention groups without 
revealing their assignment. During the data analysis phase, the person responsible for data analysis will not 
have direct access to group allocation information, so as to maintain blinding. 
Only at the end of the main analyses will the codes be decrypted in order to conduct any post hoc analyses. 
To maintain blinding during the analysis phase, participant data will be coded and stripped of information 
relating to group allocation. Access to the randomisation sequence will be restricted exclusively until the 
point when all data have been collected and prepared for analysis. 
During the course of the study, the operators involved in the intervention will not be blinded with respect to 
the assignment of participants to groups, nor will the patients, as they will be aware of the type of 
intervention. 
Blinding will be maintained until the completion of the main statistical analyses. 
Other Study Procedures 
None. 

 
 
 
 
Pag. 17 a 21 
Data Management 
Data Collection 
Demographic data, data related to clinical history, and self-report questionnaire scores will be collected. 
Demographic and clinical history data will be collected only at T0, while data from paper-based self-report 
questionnaires will be collected at all time-points of the study (T0, T1, T2 and T3). 
The self-report questionnaires used are validated instruments currently in widespread use in psychological 
research. The paper version bearing the user's ID code will be stored at the Coordinating Centre (U.O.S. 
Provincial Centre for Nutrition and Eating Disorders AULSS2 Treviso, U.O.C. CSM Treviso). 
Data Management 
Self-report questionnaire data will be entered into an Excel database. The database will be password-
protected and accessible only to authorised members of the research team. Furthermore, IT security 
measures such as data encryption and regular backups will be implemented to prevent loss of information. 
Data Storage 
Data will be stored by the Coordinating Centre (U.O.S. Provincial Centre for Nutrition and Eating Disorders 
AULSS2 Treviso, U.O.C. CSM Treviso) and kept in dedicated folders within the company computer to be 
subsequently entered into a protected database. 
Protocol Deviations 
There may be protocol deviations on an individual basis in the presence of a worsening of the clinical 
condition (as per the inclusion/exclusion criteria) and/or the need for an increase in the intensity of the 
intervention (semi-residential, residential, hospital admission). Patients will continue to be followed 
according to normal clinical practice. 
Statistical Plan 
Statistical analyses will be conducted using the Statistical Package for Social Science (SPSS) software for 
Windows (version 28.0). 
First, descriptive analyses of the sample will be conducted (variables of interest: age, level of education, Body 
Mass Index). Following the descriptive analyses of the sample, a one-way ANOVA will be used to evaluate 
any significant differences between the three groups (experimental groups and control group) with respect 
to age, BMI and scores obtained in the self-report questionnaire battery at T0 (pre-intervention), to verify 
the presence of differences between the three groups pre-intervention, which could affect the results 
obtained at T1 (post-intervention). Based on the results of the one-way ANOVA (i.e., absence or presence of 
differences between the two groups), mixed-model repeated measures ANOVA (Analysis of Variance) 3 
(Group) × 4 (Time) (in the absence of differences between the two groups) or mixed-model repeated 
measures ANCOVA (Analysis of Covariance) 3 (Group) × 4 (Time) (in the presence of differences between the 
two groups in the variables investigated) will be conducted. 

 
 
 
 
Pag. 18 a 21 
Description of the mixed-model repeated measures ANOVA/ANCOVA 3 (Group) × 4 (Time): 
The "Group" factor consists of 3 levels. The "Group" factor refers to the two experimental groups (yoga and 
FSB) and the control group; the "Time" factor corresponds to T0 (measures obtained before the start of the 
intervention from the experimental groups and the control group, which undergoes only the standard 
treatment), T1 (represented by the measures reported at the end of the intervention for the experimental 
groups and by the measures obtained at the end of 13 weeks for the control group), T2 (1-month follow-up) 
and T3 (3-month follow-up). 
The repeated measures ANOVA will be conducted in order to verify, in the different evaluation phases (T0, 
T1, T2 and T3), the presence of statistically significant variations in scores obtained from the self-report 
questionnaires relating to the psychological variables of interest (i.e., body image and eating behaviours) 
between the experimental groups and the control group. 
Additional Analyses 
If the yoga and FSB interventions emerge as effective in improving body image and eating behaviours, 
mediation analyses will also be conducted to understand the psychological mechanisms underlying the 
efficacy of the two interventions. It will therefore be investigated whether the improvement in body image 
and eating behaviours is mediated by the psychological variables hypothesised as mediators (i.e., 
embodiment, interoceptive awareness, body and functionality appreciation, mindfulness/awareness and 
self-compassion). 
Administrative Aspects 
Study Funding 
No funding is planned for the study. For the procedures planned in the groups, an application will be made 
to the non-profit Fund. 
Insurance Coverage 
Low-level intervention study; the insurance coverage of the promoting institution will be used. 
Protocol Amendments 
This study will be conducted in accordance with the current version of the protocol. Any modification to the 
document, the study design, patient safety, or that may influence the willingness of participating subjects to 
continue their participation in the study is considered an amendment and must therefore be described and 
submitted as an amendment to the protocol and/or the informed consent. All amendments will be submitted 
for approval before becoming operative. 

 
 
 
 
Pag. 19 a 21 
Ethical Considerations 
Informed Consent 
All patients eligible for the study and/or their parents will be provided with an appropriate information sheet, 
written in simple language, explaining the aims of the study and its methods of conduct. Enrolled subjects 
and their parents will be asked to sign the informed consent form, after having had time to read the 
information sheet and to clarify any doubts. 
Confidentiality 
Data will be collected in a confidential manner (with ID code). 
Conflict of Interests 
There are no conflicts of interests. 
Responsibilities and Publication Policies 
Role of the Sponsor and Investigators 
Study design: Coordinating Centre 
Data collection and management: Coordinating Centre 
Data analysis and interpretation: Coordinating Centre 
Report writing: Coordinating Centre 
Authorship: Coordinating Centre 
Data Ownership 
Data ownership belongs to the sponsor. 
Publication Policies 
At the conclusion of the study, a period of approximately 8/12 months is anticipated to make the study results 
available through participation in conferences or through scientific publications. Anonymous data may be 
the subject of publication and presentation at conferences. 
 
 
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