Actively Recruiting
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
Eligibility Criteria
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
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
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
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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