An interventional study of MIT-ED in Eating Disorders, Maladaptive Personality Trait and Personality Disorder, sponsored by GLORIA FIORAVANTI. Active, not recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by GLORIA FIORAVANTI · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to assess if Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) is effective for treating various forms of Eating Disorders (ED) and reducing dropout rates. The trial will also evaluate its feasibility and outcomes in a patient group including also underweight participants. The main questions it aims to answer are:
Participants will:
Researchers will evaluate the effectiveness of MIT-ED based on treatment adherence, symptom improvement, and the reduction of maintenance mechanisms associated with Eating Disorders. Positive results could support the design of a larger, controlled Randomized Clinical Trial (RCT).
This is a single arm study. The hypotheses are that Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) will be able to keep drop-out lower than possible, estimated \<20%; promote remission in the primary Eating Disorder (ED) measure; achieve weight gain in underweight participants.
Recruitment will stop once 64 participants have met inclusion criteria and have accepted to participate to the study. The study will recruit adults aged 18 and over, diagnosed with an ED within the past six months, from the Centro di Trattamento Integrato - Disturbi Alimentari e Obesità (CTI-Disturbi Alimentari e Obesità) in Verona and Genova. Underweight individuals will be included to evaluate MIT-ED's broader applicability.
Participants will receive up to 40 individual sessions of MIT-ED, delivered either in-person or via videoconferencing by 3 trained therapists. Therapists will receive 2 hours supervision every two weeks with 2 of Metacognitive Interpersonal Therapy designers. Therapy sessions will be randomly audio-recorded for process analysis Assessments will occur at baseline, after 20 MIT-ED sessions (approximately after 5 months), post-treatment (approximately after 10 months), and at 3 months follow-up, where publications of the results are scheduled. A longer term 12-months follow-up is planned. A research assistant will handle psychometric test administration and coordination with the clinical team.
This study will provide preliminary evidence on the feasibility and effectiveness of MIT-ED in a broader ED population, including underweight patients. The results will inform the design of a larger controlled trials to further validate MIT-ED efficacy with the hope it results as a new treatment option for patients with transdiagnostic ED.
645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.
This study's planned enrollment of 64 is close to the median of 71 across 452 interventional studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →This is the only study on the registry with GLORIA FIORAVANTI as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 1 or 2 preliminary sessions focused on typical elements of Cognitive Behavioral Therapy for Eating Disorders, including psychoeducational training on eating behaviors, an introduction to tools such as monitoring forms, weight charts, and assessments of eating behaviors like physical exercise, body checking, and episodes of binging, purging, and starvation. Before treatment starts, patients meet with a dietitian to develop a nutritional plan that normalizes calorie intake, which will be reviewed throughout treatment. After these sessions, participants will receive up to 40 weekly individual sessions. Given the inclusion of underweight patients, the protocol developed by Fioravanti and colleagues (2023) required adaptations, such as considering the effects of malnutrition on cognitive and organic functioning and extending psychotherapy for up to 40 sessions.
Other: MIT-ED
The aim is to develop healthier strategies for managing negative thoughts and feelings linked to Eating Disorder (ED) and engage patients in social interactions that fulfill their relational needs. Participants will learn that perfectionism and the need for control in ED are coping strategies shaped by interpersonal patterns with significant others, where low self-esteem and emotional dysregulation play key roles. Metacognitive Intepersonal Therapy (MIT) aims to improve individuals' ability to understand their own emotions and thoughts, recognizing maladaptive, rigid, and biased schemas about self and others. This awareness helps them form a richer understanding of others' minds and use this knowledge to respond more adaptively to social challenges. MIT also helps individuals reflect on how these schemas trigger ED behaviors and develop better coping strategies for interpersonal stressors.
Eating Disorder Examination Questionnaire (EDE-Q 6.0; Fairburn & Beglin, 1994)
A self report measure assessing eating disorders over the past 4 weeks, providing a measure of the range of severity of eating disorder features. The questionnaire consists of 28 items with responses ranging from 0 to 6 (where 6 indicates higher gravity of the disorder).
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Eating Disorder Examination Interview (EDE, Fairburn, Cooper & O'Connor; 2014).
An interview based on the Eating Disorder Examination Questionnaire-6 questionnaire, which provides information about the main behavioural characteristics of eating disorders. Questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28-day period. The test is scored on a 7-point scale from 0-6. With a zero score indicating not having engaged in the questioned behavior.
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Binge Eating Scale (BES; Gormally et al., 1992)
A self-report questionnaire of the behavioral, cognitive and emotional features of objective binge eating (OBE). The total score ranges from 0 to 46, with higher scores correlating with more frequent and severe binge eating behaviors.
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Body Mass Index (BMI)
As an additional measure of the recovery from eating disorder (BMI \<18.5). Body Mass Index is a measure of weight relative to height.
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Disorders (SCID-5; Michael B. First, Janet B.W. Williams)
For assessing and defining Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Model for Personality Disorders. The scoring system for the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Disorders (SCID-5) varies depending on the specific disorder being assessed, but generally a minimum score indicates that the criteria for a particular disorder are not met. Instead, a maximum score (1 or 2) usually signifies that the individual meets the criteria for that disorder, with a score of 2 typically indicating a stronger or more definite endorsement of the disorder's symptoms, or a more severe presentation.
Time frame: At baseline and after 20 sessions of therapy (approximately after 5 months)
Symptom Check List (SCL-90)
A measure of psychopathology symptoms and their intensity at a specific point in time. It includes 90 items that assess various symptom categories, such as anxiety, depression, and interpersonal sensitivity, among others. The overall score, known as the Global Severity Index (GSI), provides a measure of the overall psychological distress, and higher scores generally reflect greater symptom intensity and distress.
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)
It assesses difficulties in understanding, processing, or describing emotions. It consists of 20 items that assess emotional processing and expression. Global score ranges from 20 to 100, where 100 indicates the highest level of alexithymia.
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
A self-report scale measuring individual differences in the ability to identify, accept and manage emotional experiences. This measure help in understanding emotional dysregulation that might underlie the disorders. Global score ranges from 33 to 132, where 132 represents the highest level of difficulty in emotion regulation.
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Multidimensional Perfectionism Scale (MPS; Hewitt & Flett, 2004)
Measures the presence and extent of the perfectionism construct. It consists of 45 items, with each item rated on a scale from 1 to 7. A higher score indicates higher levels of perfectionism.
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Perfectionistic Cognitions Inventory (PCI; Flett, Hewitt, Blankstein & Gray, 1998)
Investigate the presence of perfectionist thoughts and cognitions. The Perfectionistic Cognitions Inventory consists of 15 items, each rated on a scale from 0 to 4. A higher score indicates greater concern with perfectionism.
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Rosenberg Self-Exteem Scale (RSES; Rosenberg, 1965)
Assesses the subject's level of self-esteem. The global score ranges from 0 to 30, where higher scores indicate higher self-esteem.
Time frame: Time Frame: Change from baseline until after 20 sessions (approximately after 5 months), at the end of the treatment (approximately after 10 months) and in the following 3 months after treatment (approximately after 13 months).
Plan to share: Yes — Outcomes, age, gender
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 10 years
Access criteria: Someone who has a request
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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