Body ImageNCT07512479
Effectiveness of Hatha Yoga and From Feeling to Seeing the Body (FSB) in Female Adolescents and Young Adults With Eating Disorders.
A study testing Hatha Yoga Group (Y) and From Feeling to Seeing the Body Group (FSB) in people with Body Image and Eating Disorders, run by Azienda Ulss 2 Marca Trevigiana at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 25 years, women only
- Conditions the study is for
- Body Image, Eating Disorders, Anorexia Nervosa
- What is being tested?
- Hatha Yoga Group (Y) and From Feeling to Seeing the Body Group (FSB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2025to 27 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read more
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.
Read the detailed description
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".
- Conditions
- Body Image, Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- Being tested
- Hatha Yoga Group (Y), From Feeling to Seeing the Body Group (FSB), Control Group (C)
- Keywords
- body image, yoga, embodiment, eating disorders, anorexia, bulimia, body appreciation, body functionality, From Feeling to Seeing the Body (FSB), body, mirror
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Anorexia, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha Yoga Group (Y)Behavioural
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.
From Feeling to Seeing the Body Group (FSB)Behavioural
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.
Control Group (C)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hatha Yoga Group (Y) | Experimental | Patients will continue Treatment as Usual (TAU) and will additionally attend one weekly Hatha Yoga session. Receives: Behavioral: Hatha Yoga Group (Y) |
| From Feeling to Seeing the Body Group (FSB) | Experimental | Patients will continue Treatment As Usual and will additionally attend one weekly FSB session. Receives: Behavioral: From Feeling to Seeing the Body Group (FSB) |
| Control Group (C) | Active comparator | Patients will continue with treatment as usual (TAU) which consists of periodic psychiatric, psychotherapeutic, nutritional and dietetic visits. Receives: Behavioral: Control Group (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Secondary outcomes (1)
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.
Measured: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start10 Mar 2025
- Primary completion1 Oct 2025
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-center, randomized, controlled, experimental non-pharmacological intervention trial with a non-profit purpose. Three groups are planned: Control Group (C): participants will receive treatment as usual (Specialist Supportive Clinical Management; SSCM), which includes periodic psychiatric, psychotherapeutic, nutritional, and dietary consultations. Yoga Group (Y): participants will receive treatment as usual (SSCM) plus one weekly group session of Hatha Yoga. From Feeling to Seeing the Body Group (FSB): participants will receive treatment as usual (SSCM) plus one weekly FSB session conducted in pairs. Patients will be randomly assigned to the three groups (C, Y, FSB) using the Research Randomizer software. Each group or pair will participate in the same number of sessions and will receive the same type of intervention across groups; the session structure will remain identical in all subgroups.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ulss 2 Marca Trevigiana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Fuligno, Azienda Ulss 2 Marca Trevigiana
- Investigators
- Chiara Fuligno, TNPEE, Principal investigator, Azienda Ulss 2 Marca Trevigiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512479
- Sponsor's protocol ID
- 2024-129 (ID studio CET)
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A data sharing plan will be developed by the research team after the publication of the first manuscript.
Publications
Torres S, Vieira AI, Vieira FM, Miller KM, Guerra MP, Lencastre L, Reis AC, Timoteo 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.
PubMed 38892718Tylka Tracy L. , Piran Niva , Handbook of Positive Body Image and Embodiment. Construct, Protective Factors and Interventions. Oxford University Press (2019).
Tylka TL, Wood-Barcalow NL. What is and what is not positive body image? Conceptual foundations and construct definition. Body Image. 2015 Jun;14:118-29. doi: 10.1016/j.bodyim.2015.04.001. Epub 2015 Apr 25.
PubMed 25921657Pavani F, Galfano G. Self-attributed body-shadows modulate tactile attention. Cognition. 2007 Jul;104(1):73-88. doi: 10.1016/j.cognition.2006.05.007. Epub 2006 Jul 12.
PubMed 16839537O'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. doi: 10.1186/s40337-023-00845-5.
PubMed 37684706Korsak, Emilia. (2022). Body-oriented therapy in the prevention of eating disorders. A systematic review. Przegląd Psychologiczny. 65. 177-195.
Cox AE, Tylka TL. A conceptual model describing mechanisms for how yoga practice may support positive embodiment. Eat Disord. 2020 Jul-Aug;28(4):376-399. doi: 10.1080/10640266.2020.1740911. Epub 2020 Mar 22.
PubMed 32200707Cook-Cottone CP. Incorporating positive body image into the treatment of eating disorders: A model for attunement and mindful self-care. Body Image. 2015 Jun;14:158-67. doi: 10.1016/j.bodyim.2015.03.004. Epub 2015 Apr 15.
PubMed 25886712Cook-Cottone, C. (2006), The attuned representation model for the primary prevention of eating disorders: An overview for school psychologists. Psychol. Schs., 43: 223-230.
Cerea S, Iannattone S, Mancin P, Bottesi G, Marchetti I. Eating disorder symptom dimensions and protective factors: A structural network analysis study. Appetite. 2024 Jun 1;197:107326. doi: 10.1016/j.appet.2024.107326. Epub 2024 Mar 27.
PubMed 38552742Alleva JM, Tylka TL. Body functionality: A review of the literature. Body Image. 2021 Mar;36:149-171. doi: 10.1016/j.bodyim.2020.11.006. Epub 2020 Dec 13.
PubMed 33321273
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07512479
- Acronym / sponsor ID
- 2024-129 (ID studio CET)
- Conditions
- Body Image, Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- Keywords
- body image, yoga, embodiment, eating disorders, anorexia, bulimia, body appreciation, body functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Azienda Ulss 2 Marca TrevigianaUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a single-center, randomized, controlled, experimental non-pharmacological intervention trial with a non-profit purpose. Three groups are planned: Control Group (C): participants will receive treatment as usual (Specialist Supportive Clinical Management; SSCM), which includes periodic psychiatric, psychotherapeutic, nutritional, and dietary consultations. Yoga Group (Y): participants will receive treatment as usual (SSCM) plus one weekly group session of Hatha Yoga. From Feeling to Seeing the Body Group (FSB): participants will receive treatment as usual (SSCM) plus one weekly FSB session conducted in pairs. Patients will be randomly assigned to the three groups (C, Y, FSB) using the Research Randomizer software. Each group or pair will participate in the same number of sessions and will receive the same type of intervention across groups; the session structure will remain identical in all subgroups.
| Arm | Type | Receives |
|---|---|---|
| Hatha Yoga Group (Y) | Experimental | Behavioral: Hatha Yoga Group (Y)Patients will continue Treatment as Usual (TAU) and will additionally attend one weekly Hatha Yoga session. |
| From Feeling to Seeing the Body Group (FSB) | Experimental | Behavioral: From Feeling to Seeing the Body Group (FSB)Patients will continue Treatment As Usual and will additionally attend one weekly FSB session. |
| Control Group (C) | Active comparator | Behavioral: Control Group (C)Patients will continue with treatment as usual (TAU) which consists of periodic psychiatric, psychotherapeutic, nutritional and dietetic visits. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hatha Yoga Group (Y)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. | Behavioural | Hatha Yoga Group (Y) |
| From Feeling to Seeing the Body Group (FSB)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. | Behavioural | From Feeling to Seeing the Body Group (FSB) |
| Control Group (C)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. | Behavioural | Control Group (C) |
Primary outcome
Body Dissatisfaction and Dysfunctional Eating Behaviors as Measured by the Eating Disorder Inventory-3 (EDI-3)
Time frame: 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.
1 secondary outcome
Embodiment as Measured by the Experience of Embodiment Scale (EES)
Time frame: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 38892718Torres S, Vieira AI, Vieira FM, Miller KM, Guerra MP, Lencastre L, Reis AC, Timoteo 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.
- BackgroundTylka Tracy L. , Piran Niva , Handbook of Positive Body Image and Embodiment. Construct, Protective Factors and Interventions. Oxford University Press (2019).
- Background: PubMed 25921657Tylka TL, Wood-Barcalow NL. What is and what is not positive body image? Conceptual foundations and construct definition. Body Image. 2015 Jun;14:118-29. doi: 10.1016/j.bodyim.2015.04.001. Epub 2015 Apr 25.
- Background: PubMed 16839537Pavani F, Galfano G. Self-attributed body-shadows modulate tactile attention. Cognition. 2007 Jul;104(1):73-88. doi: 10.1016/j.cognition.2006.05.007. Epub 2006 Jul 12.
- Background: PubMed 37684706O'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. doi: 10.1186/s40337-023-00845-5.
- BackgroundKorsak, Emilia. (2022). Body-oriented therapy in the prevention of eating disorders. A systematic review. Przegląd Psychologiczny. 65. 177-195.
- Background: PubMed 32200707Cox AE, Tylka TL. A conceptual model describing mechanisms for how yoga practice may support positive embodiment. Eat Disord. 2020 Jul-Aug;28(4):376-399. doi: 10.1080/10640266.2020.1740911. Epub 2020 Mar 22.
- Background: PubMed 25886712Cook-Cottone CP. Incorporating positive body image into the treatment of eating disorders: A model for attunement and mindful self-care. Body Image. 2015 Jun;14:158-67. doi: 10.1016/j.bodyim.2015.03.004. Epub 2015 Apr 15.
- BackgroundCook-Cottone, C. (2006), The attuned representation model for the primary prevention of eating disorders: An overview for school psychologists. Psychol. Schs., 43: 223-230.
- Background: PubMed 38552742Cerea S, Iannattone S, Mancin P, Bottesi G, Marchetti I. Eating disorder symptom dimensions and protective factors: A structural network analysis study. Appetite. 2024 Jun 1;197:107326. doi: 10.1016/j.appet.2024.107326. Epub 2024 Mar 27.
- Background: PubMed 33321273Alleva JM, Tylka TL. Body functionality: A review of the literature. Body Image. 2021 Mar;36:149-171. doi: 10.1016/j.bodyim.2020.11.006. Epub 2020 Dec 13.
- Individual participant dataSharing planned: No. A data sharing plan will be developed by the research team after the publication of the first manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Fuligno, TNPEE principal investigator
Azienda Ulss 2 Marca Trevigiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha Yoga Group (Y) and From Feeling to Seeing the Body Group (FSB) in people with Body Image and Eating Disorders, run by Azienda Ulss 2 Marca Trevigiana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Dissatisfaction and Dysfunctional Eating Behaviors as Measured by the Eating Disorder Inventory-3 (EDI-3) (time frame: Baseline (T0), Week 13 (T1, post-treatment), Week 17 (T2, 1-month follow-up), Week 26 (T3, 3-month follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07512479, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.