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NCT Number: NCT06693089

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Eating Disorders Behavior Behavioral Symptoms Child Behavior Cognition Disorders Cognitive Dysfunction Dysfunctional Behavior Psychology Emotion Regulation Emotional Regulation Feeding and Eating Disorders Maladaptive Personality Trait Mental Disorders Neurocognitive Disorders Pathological Conditions, Signs and Symptoms Perfectionism Personality Disorder Personality Disorders Personality Trait Problem Behavior Self Esteem Self-Control Signs and Symptoms Signs and Symptoms, Digestive Social Behavior Social Interaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Trattamento Integrato Disturbi Alimentari e Obesità, Verona, Italia, Italy

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About this study

This is a single arm study. The hypotheses are that Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) will be able to keep drop-out lower than possible, estimated <20%; promote remission in the primary Eating Disorder (ED) measure; achieve weight gain in underweight participants.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Receiving ongoing psychiatric, other psychotherapeutic treatment
  • Coexisting psychiatric disorders precludeing eating disorder-focused treatment or that requires specialized treatment: bipolar I, psychosis, alcohol or substance abuse, suicidality. PTSD is an exclusion criteria as long as its symptoms as prominent so to require a specialized empirically supported treatment
  • Intellectual disability

Treatment and study plan

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.

Primary outcomes

  1. Eating Disorder Examination Questionnaire (EDE-Q 6.0; Fairburn & Beglin, 1994)

    Time frame: 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).

    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).

  2. Eating Disorder Examination Interview (EDE, Fairburn, Cooper & O'Connor; 2014).

    Time frame: 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).

    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.

Secondary outcomes

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

    Time frame: 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).

    A self-report questionnaire of the behavioral, cognitive and emotional features of objective binge eating (OBE). The total score ranges from 0 to 46, with higher scores correlating with more frequent and severe binge eating behaviors.

  2. Body Mass Index (BMI)

    Time frame: 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).

    As an additional measure of the recovery from eating disorder (BMI <18.5). Body Mass Index is a measure of weight relative to height.

  3. Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Disorders (SCID-5; Michael B. First, Janet B.W. Williams)

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

    For assessing and defining Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Model for Personality Disorders. The scoring system for the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Disorders (SCID-5) varies depending on the specific disorder being assessed, but generally a minimum score indicates that the criteria for a particular disorder are not met. Instead, a maximum score (1 or 2) usually signifies that the individual meets the criteria for that disorder, with a score of 2 typically indicating a stronger or more definite endorsement of the disorder's symptoms, or a more severe presentation.

  4. Symptom Check List (SCL-90)

    Time frame: 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).

    A measure of psychopathology symptoms and their intensity at a specific point in time. It includes 90 items that assess various symptom categories, such as anxiety, depression, and interpersonal sensitivity, among others. The overall score, known as the Global Severity Index (GSI), provides a measure of the overall psychological distress, and higher scores generally reflect greater symptom intensity and distress.

  5. Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)

    Time frame: 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).

    It assesses difficulties in understanding, processing, or describing emotions. It consists of 20 items that assess emotional processing and expression. Global score ranges from 20 to 100, where 100 indicates the highest level of alexithymia.

  6. Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)

    Time frame: 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).

    A self-report scale measuring individual differences in the ability to identify, accept and manage emotional experiences. This measure help in understanding emotional dysregulation that might underlie the disorders. Global score ranges from 33 to 132, where 132 represents the highest level of difficulty in emotion regulation.

  7. Multidimensional Perfectionism Scale (MPS; Hewitt & Flett, 2004)

    Time frame: 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).

    Measures the presence and extent of the perfectionism construct. It consists of 45 items, with each item rated on a scale from 1 to 7. A higher score indicates higher levels of perfectionism.

  8. Perfectionistic Cognitions Inventory (PCI; Flett, Hewitt, Blankstein & Gray, 1998)

    Time frame: 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).

    Investigate the presence of perfectionist thoughts and cognitions. The Perfectionistic Cognitions Inventory consists of 15 items, each rated on a scale from 0 to 4. A higher score indicates greater concern with perfectionism.

  9. Rosenberg Self-Exteem Scale (RSES; Rosenberg, 1965)

    Time frame: 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).

    Assesses the subject's level of self-esteem. The global score ranges from 0 to 30, where higher scores indicate higher self-esteem.

Sponsors and collaborators

Lead sponsor

GLORIA FIORAVANTI

Other

Collaborators

  • Angus McBeth, University of Edinburgh
  • Francesca Travagnin, Centro di Trattamento Integrato Disturbi Alimentari e Obesità, Verona, Italy
  • Giancarlo Dimaggio, Centro di Terapia Metacognitiva Interpersonale, Rome, Italy
  • Martina Nicolis, Centro Trattamento Integrato Disturbi alimentari e Obesità, Verona, Italy
  • Raffaele Popolo, Centro di Terapia Metacgontiva Interpersonale, Roma, Italy
  • Valentina Nicolosi, Centro di Trattamento Integrato Disturbi Alimentari e Obesità, Verona, Italy

Registry information

Official study title

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders Including Underweight: Study Protocol for a Single-arm Pilot Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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