Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

Summary

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:

* 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).

Conditions

• Eating Disorders
• Maladaptive Personality Trait
• Personality Disorder
• Personality Trait
• Emotion Regulation
• Social Interaction
• Perfectionism
• Self Esteem
• Cognitive Dysfunction
• Dysfunctional Behavior Psychology

Interventions

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.

Sponsors & Collaborators

• Giancarlo Dimaggio, Centro di Terapia Metacognitiva Interpersonale, Rome, Italy

  collaborator UNKNOWN

• Martina Nicolis, Centro Trattamento Integrato Disturbi alimentari e Obesità, Verona, Italy

  collaborator UNKNOWN

• Francesca Travagnin, Centro di Trattamento Integrato Disturbi Alimentari e Obesità, Verona, Italy

  collaborator UNKNOWN

• Valentina Nicolosi, Centro di Trattamento Integrato Disturbi Alimentari e Obesità, Verona, Italy

  collaborator UNKNOWN

• Raffaele Popolo, Centro di Terapia Metacgontiva Interpersonale, Roma, Italy

  collaborator UNKNOWN

• Angus McBeth, University of Edinburgh

  collaborator UNKNOWN

• GLORIA FIORAVANTI

  lead OTHER

Principal Investigators

• Giancarlo Dimaggio · Centro di Terapia Metacognitiva Interpersonale, Roma

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-08

Primary Completion

2026-04-14

Completion

2026-10-31

Countries

• Italy

Study Locations