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| Name | Class |
|---|---|
| Giancarlo Dimaggio, Centro di Terapia Metacognitiva Interpersonale, Rome, Italy | UNKNOWN |
| Martina Nicolis, Centro Trattamento Integrato Disturbi alimentari e Obesità , Verona, Italy | UNKNOWN |
| Francesca Travagnin, Centro di Trattamento Integrato Disturbi Alimentari e Obesità , Verona, Italy |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: MIT-ED | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIT-ED | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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: 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: 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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: 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giancarlo Dimaggio | Centro di Terapia Metacognitiva Interpersonale, Roma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Trattamento Integrato Disturbi Alimentari e Obesità | Verona | Italia | 37122 | Italy | ||
| Centro Trattamento Integrato Disturbi Alimentari e Obesità |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25894667 | Background | Accurso EC, Fitzsimmons-Craft EE, Ciao A, Cao L, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ, Wonderlich SA, Peterson CB. Therapeutic alliance in a randomized clinical trial for bulimia nervosa. J Consult Clin Psychol. 2015 Jun;83(3):637-42. doi: 10.1037/ccp0000021. Epub 2015 Apr 20. | |
| 24131861 | Background |
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Outcomes, age, gender
10 years
Someone who has a request
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| UNKNOWN |
| Valentina Nicolosi, Centro di Trattamento Integrato Disturbi Alimentari e Obesità , Verona, Italy | UNKNOWN |
| Raffaele Popolo, Centro di Terapia Metacgontiva Interpersonale, Roma, Italy | UNKNOWN |
| Angus McBeth, University of Edinburgh | UNKNOWN |
The study is a single arm study to evaluate MIT-ED effectiveness on a larger sample of adults with transdiagnostic ED presentations which include underweight participants. They will receive up to 40 individual sessions of MIT-ED. The study is run in an private outpatient clinic specialized in eating disorder treatment. Therapies will be delivered both in person or through videoconferencing. Three therapists will be involved in the trial, all trained in MIT.
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Treatment-seeking participants will first receive an assessment screening visit. Once evaluated for inclusion/exclusion criteria, and informed written consent has been obtained, baseline measures about primary and secondary outcomes will be completed. Participants will then be proposed for inclusion in the study.
Recruitment will stop once 64 participants have met inclusion criteria and have accepted to participate to the study.
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|
| 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: 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. | 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: 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: 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: 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: 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: 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: 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). |
| Verona |
| Verona |
| 37122 |
| Italy |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D010554 | Personality Disorders |
| D000080103 | Emotional Regulation |
| D060825 | Cognitive Dysfunction |
| D000066553 | Problem Behavior |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001526 | Behavioral Symptoms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D002652 | Child Behavior |
Not provided
Not provided