Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06693089

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

Led by GLORIA FIORAVANTI · Updated on 2024-12-09

64

Participants Needed

2

Research Sites

65 weeks

Total Duration

On this page

Sponsors

G

GLORIA FIORAVANTI

Lead Sponsor

S

Simone Cheli

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult outpatients aged 18 years or older
  • Diagnosed with an eating disorder requiring treatment
  • Body mass index (BMI) between 17.5 and 40
  • Provided informed consent to participate
Not Eligible

You will not qualify if you...

  • Currently receiving ongoing psychiatric or other psychotherapeutic treatment
  • Presence of psychiatric disorders that prevent eating disorder-focused treatment or require specialized care, including bipolar I disorder, psychosis, alcohol or substance abuse, suicidality
  • Post-traumatic stress disorder (PTSD) with symptoms severe enough to require specialized treatment
  • Intellectual disability

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Centro Trattamento Integrato Disturbi Alimentari e Obesità

Verona, Italia, Italy, 37122

Not Yet Recruiting

2

Centro Trattamento Integrato Disturbi Alimentari e Obesità

Verona, Verona, Italy, 37122

Actively Recruiting

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Research Team

G

Gloria Fioravanti

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight | DecenTrialz