Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight
NCT ID: NCT06693089
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2024-11-08
2026-02-07
Brief Summary
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* Does MIT-ED improve eating disorder symptoms and reduce overall maintenance factors, as alexithymia, emotional dysregulation, maladaptive perfectionism, and self-esteem?
* Is MIT-ED effective in reducing the severity of personality disorders and associated global psychiatric symptoms?
* What are the dropout rates and adherence levels for patients receiving MIT-ED?
Participants will:
* Undergo an initial screening to confirm eligibility, including a comprehensive clinical interview and assessments based on inclusion and exclusion criteria for the study.
* Receive up to 40 individual sessions of MIT-ED, each lasting 50-60 minutes, over a period of approximately 10-12 months.
* Attend regular assessment focusing on eating disorder symptoms (Eating Disorder Examination Questionnaire, EDE-Q 6.0, and ED Interview, EDE), emotional dysregulation (Difficulties in Emotion Regulation Scale, DERS), alexithymia (Toronto Alexithymia Scale-20, TAS-20), and self-esteem (Rosenberg Self-Esteem Scale, RSES). Assessment will be conducted at baseline (before starting MIT-ED sessions), after 20 MIT-ED sessions (approximately after 5 months), post-treatment (approximately after 10 months), and at 3 months follow-up. A longer 12-months follow-up is planned.
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).
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Recruitment will stop once 64 participants have met inclusion criteria and have accepted to participate to the study.
Study Groups
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Experimental: MIT-ED
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Having an Eating Disorder for which they required treatment
* BMI between 17.5 and 40
* Provision of informed consent
Exclusion Criteria
* Intellectual disability
18 Years
ALL
No
Sponsors
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Simone Cheli
UNKNOWN
Angus MacBeth
UNKNOWN
Francesca Travagnin
UNKNOWN
Martina Nicolis
UNKNOWN
Valentina Nicolosi
UNKNOWN
Raffaele Popolo
UNKNOWN
Giancarlo Dimaggio
UNKNOWN
GLORIA FIORAVANTI
OTHER
Responsible Party
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GLORIA FIORAVANTI
Gloria Fioravanti
Principal Investigators
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Giancarlo Dimaggio
Role: STUDY_CHAIR
Centro di Terapia Metacognitiva Interpersonale, Roma
Locations
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Centro Trattamento Integrato Disturbi Alimentari e Obesità
Verona, Italia, Italy
Centro Trattamento Integrato Disturbi Alimentari e Obesità
Verona, Verona, Italy
Countries
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Central Contacts
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Facility Contacts
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Gloria Fioravanti
Role: primary
Simone C
Role: backup
Angus MacBeth
Role: backup
Francesca Travagnin
Role: backup
Martina Nicolis
Role: backup
Valentina Nicolosi
Role: backup
Raffaele Popolo
Role: backup
Gloria Fioravanti
Role: primary
References
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Other Identifiers
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HD7ABEBGC6@ADA91162
Identifier Type: -
Identifier Source: org_study_id