Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

NCT06693089 | Recruiting

• 1 other identifier: HD7ABEBGC6@ADA91162
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Behavioral Symptoms; Feeding and Eating Disorders; Personality Disorders; Cognitive Dysfunction; Problem Behavior

Outcome Measures

Primary Outcomes (2)

• 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).

Secondary Outcomes (9)

• Binge Eating Scale (BES; Gormally et al., 1992)

  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).

• Body Mass Index (BMI)

  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)

  At baseline and after 20 sessions of therapy (approximately after 5 months)

• Symptom Check List (SCL-90)

  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)

  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).

Study Arms (1)

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.

Other: MIT-ED

Interventions

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.

Experimental: MIT-ED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult outpatients (from age 18 years)
• Having an Eating Disorder for which they required treatment
• BMI between 17.5 and 40
• Provision of informed consent

You may not qualify if:

• Receiving ongoing psychiatric, other psychotherapeutic treatment
• Intellectual disability

Sponsors & Collaborators

• GLORIA FIORAVANTI: lead
• Simone Cheli: collaborator
• Angus MacBeth: collaborator
• Francesca Travagnin: collaborator
• Martina Nicolis: collaborator
• Valentina Nicolosi: collaborator
• Raffaele Popolo: collaborator
• Giancarlo Dimaggio: collaborator

Study Sites (2)

Centro Trattamento Integrato Disturbi Alimentari e Obesità

Verona, Italia, 37122, Italy

NOT YET RECRUITING

Centro Trattamento Integrato Disturbi Alimentari e Obesità

Verona, Verona, 37122, Italy

RECRUITING

Related Publications (61)

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MeSH Terms

Conditions

Feeding and Eating Disorders; Personality Disorders; Emotional Regulation; Cognitive Dysfunction; Problem Behavior; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior; Child Behavior

Study Officials

• Giancarlo Dimaggio

  Centro di Terapia Metacognitiva Interpersonale, Roma

  STUDY CHAIR

Central Study Contacts

Gloria Fioravanti

CONTACT

348 9255483; gloria_fioravanti@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gloria Fioravanti

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 18, 2024
• Study Start: November 8, 2024
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 10 years
• Access Criteria: Someone who has a request

Locations

IT (2)