Eating DisordersNCT06693089

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

A study testing MIT-ED in people with Eating Disorders and Maladaptive Personality Trait, run by GLORIA FIORAVANTI at 2 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Eating Disorders, Maladaptive Personality Trait, Personality Disorder
What is being tested?: MIT-ED
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 2 sitesItaly
Study dates: 8 Nov 2024to 31 Oct 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

Centro Trattamento Integrato Disturbi Alimentari e Obesità
Verona, Italia, 37122
Centro Trattamento Integrato Disturbi Alimentari e Obesità
Verona, Verona, 37122

Other trials in Italy

About this study

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

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).

Read the detailed description

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.

Conditions: Eating Disorders, Maladaptive Personality Trait, Personality Disorder, Personality Trait, Emotion Regulation, Social Interaction
Being tested: MIT-ED
Keywords: Mental Disorders, Cognition Disorders, Neurocognitive Disorders, Behavioral Symptoms, Feeding and Eating Disorders, Personality Disorders, Cognitive Dysfunction, Problem Behavior
Medical subject headings: Feeding and Eating Disorders, Personality Disorders, Emotional Regulation, Cognitive Dysfunction, Problem Behavior, Mental Disorders, Cognition Disorders, Neurocognitive Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MIT-EDOther
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.

Study groups in NCT06693089
Study group	Role	What they receive
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. Receives: Other: MIT-ED

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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)
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.
Measured: 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)
As an additional measure of the recovery from eating disorder (BMI <18.5). Body Mass Index is a measure of weight relative to height.
Measured: 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)
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.
Measured: At baseline and after 20 sessions of therapy (approximately after 5 months)
Symptom Check List (SCL-90)
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.
Measured: 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)
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.
Measured: 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).
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
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.
Measured: 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).
Multidimensional Perfectionism Scale (MPS; Hewitt & Flett, 2004)
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.
Measured: 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).
Perfectionistic Cognitions Inventory (PCI; Flett, Hewitt, Blankstein & Gray, 1998)
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.
Measured: 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).
Rosenberg Self-Exteem Scale (RSES; Rosenberg, 1965)
Assesses the subject's level of self-esteem. The global score ranges from 0 to 30, where higher scores indicate higher self-esteem.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 202431 Oct 2026

First posted18 Nov 2024
Study start8 Nov 2024
Primary completion14 Apr 2026
Study completion31 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (61)Papers the sponsor has linked to this study.
Other trials for Eating DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 64 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06693089
Sponsor's protocol ID: HD7ABEBGC6@ADA91162
Status last verified: May 2026
First submitted: 7 Nov 2024
Last updated: 15 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Outcomes, age, gender

Publications

Accurso EC, Fitzsimmons-Craft EE, Ciao A, Cao L, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ, Wonderlich SA, Peterson CB. Therapeutic alliance in a randomized clinical trial for bulimia nervosa. J Consult Clin Psychol. 2015 Jun;83(3):637-42. doi: 10.1037/ccp0000021. Epub 2015 Apr 20.
PubMed 25894667
Zipfel S, Wild B, Gross G, Friederich HC, Teufel M, Schellberg D, Giel KE, de Zwaan M, Dinkel A, Herpertz S, Burgmer M, Lowe B, Tagay S, von Wietersheim J, Zeeck A, Schade-Brittinger C, Schauenburg H, Herzog W; ANTOP study group. Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in outpatients with anorexia nervosa (ANTOP study): randomised controlled trial. Lancet. 2014 Jan 11;383(9912):127-37. doi: 10.1016/S0140-6736(13)61746-8. Epub 2013 Oct 14.
PubMed 24131861
Wilson GT, Fairburn CC, Agras WS, Walsh BT, Kraemer H. Cognitive-behavioral therapy for bulimia nervosa: time course and mechanisms of change. J Consult Clin Psychol. 2002 Apr;70(2):267-74.
PubMed 11952185
Westwood H, Kerr-Gaffney J, Stahl D, Tchanturia K. Alexithymia in eating disorders: Systematic review and meta-analyses of studies using the Toronto Alexithymia Scale. J Psychosom Res. 2017 Aug;99:66-81. doi: 10.1016/j.jpsychores.2017.06.007. Epub 2017 Jun 11.
PubMed 28712432
Watson HJ, Fursland A, Byrne S. Treatment engagement in eating disorders: who exits before treatment? Int J Eat Disord. 2013 Sep;46(6):553-9. doi: 10.1002/eat.22085. Epub 2013 Feb 25.
PubMed 23436476
Treasure J, Cardi V, Leppanen J, Turton R. New treatment approaches for severe and enduring eating disorders. Physiol Behav. 2015 Dec 1;152(Pt B):456-65. doi: 10.1016/j.physbeh.2015.06.007. Epub 2015 Jun 6.
PubMed 26057573
Treasure J, Sepulveda AR, MacDonald P, Whitaker W, Lopez C, Zabala M, Kyriacou O, Todd G. The assessment of the family of people with eating disorders. Eur Eat Disord Rev. 2008 Jul;16(4):247-55. doi: 10.1002/erv.859.
PubMed 18240125
Thompson-Brenner H, Shingleton RM, Thompson DR, Satir DA, Richards LK, Pratt EM, Barlow DH. Focused vs. Broad enhanced cognitive behavioral therapy for bulimia nervosa with comorbid borderline personality: A randomized controlled trial. Int J Eat Disord. 2016 Jan;49(1):36-49. doi: 10.1002/eat.22468. Epub 2015 Dec 9.
PubMed 26649812
Tatham M. The role of imagery-based techniques in cognitive-behavioural therapy for adults with eating disorders. Clin Psychol Rev. 2011 Nov;31(7):1101-9. doi: 10.1016/j.cpr.2011.06.008. Epub 2011 Jul 19.
PubMed 21820388
Sodersten P, Bergh C, Leon M, Brodin U, Zandian M. Cognitive behavior therapy for eating disorders versus normalization of eating behavior. Physiol Behav. 2017 May 15;174:178-190. doi: 10.1016/j.physbeh.2017.03.016. Epub 2017 Mar 16.
PubMed 28322911
Simpson S, Azam F, Brown S, Hronis A, Brockman R. The impact of personality disorders and personality traits on psychotherapy treatment outcome of eating disorders: A systematic review. Personal Ment Health. 2022 Aug;16(3):217-234. doi: 10.1002/pmh.1533. Epub 2021 Dec 5.
PubMed 34866357
Simonsen S, Popolo R, Juul S, Frandsen FW, Sorensen P, Dimaggio G. Treating Avoidant Personality Disorder With Combined Individual Metacognitive Interpersonal Therapy and Group Mentalization-Based Treatment: A Pilot Study. J Nerv Ment Dis. 2022 Mar 1;210(3):163-171. doi: 10.1097/NMD.0000000000001432.
PubMed 34710894
Semerari A, Colle L, Pellecchia G, Buccione I, Carcione A, Dimaggio G, Nicolo G, Procacci M, Pedone R. Metacognitive dysfunctions in personality disorders: correlations with disorder severity and personality styles. J Pers Disord. 2014 Dec;28(6):751-66. doi: 10.1521/pedi_2014_28_137.
PubMed 24689762
Sassaroli S, Ruggiero GM. The role of stress in the association between low self-esteem, perfectionism, and worry, and eating disorders. Int J Eat Disord. 2005 Mar;37(2):135-41. doi: 10.1002/eat.20079.
PubMed 15732079
Ruggiero GM, Levi D, Ciuna A, Sassaroli S. Stress situation reveals an association between perfectionism and drive for thinness. Int J Eat Disord. 2003 Sep;34(2):220-6. doi: 10.1002/eat.10191.
PubMed 12898558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Eating Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders Including Underweight: Study Protocol for a Single-arm Pilot Study
ClinicalTrials.gov ID: NCT06693089
Acronym / sponsor ID: HD7ABEBGC6@ADA91162
Conditions: Eating Disorders, Maladaptive Personality Trait, Personality Disorder, Personality Trait, Emotion Regulation, Social Interaction
Keywords: Mental Disorders, Cognition Disorders, Neurocognitive Disorders, Behavioral Symptoms, Feeding and Eating Disorders, Personality Disorders, Cognitive Dysfunction, Problem Behavior
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 64 participants (estimated)
Lead sponsor: GLORIA FIORAVANTIUniversity, hospital or other
Collaborators: Giancarlo Dimaggio, Centro di Terapia Metacognitiva Interpersonale, Rome, Italy, Martina Nicolis, Centro Trattamento Integrato Disturbi alimentari e Obesità, Verona, Italy, Francesca Travagnin, Centro di Trattamento Integrato Disturbi Alimentari e Obesità, Verona, Italy, Valentina Nicolosi, Centro di Trattamento Integrato Disturbi Alimentari e Obesità, Verona, Italy, Raffaele Popolo, Centro di Terapia Metacgontiva Interpersonale, Roma, Italy, Angus McBeth, University of Edinburgh
Study start: 8 Nov 2024 (actual)
Primary completion: 14 Apr 2026 (actual)
Study completion: 31 Oct 2026 (estimated)
First posted: 18 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Experimental: MIT-ED	Experimental	Other: MIT-EDParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MIT-EDThe 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.	Other	Experimental: MIT-ED

Primary outcome

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).
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.

9 secondary outcomes

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).
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).
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)
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).
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).
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).
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).
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).
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).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Background: PubMed 25894667Accurso EC, Fitzsimmons-Craft EE, Ciao A, Cao L, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ, Wonderlich SA, Peterson CB. Therapeutic alliance in a randomized clinical trial for bulimia nervosa. J Consult Clin Psychol. 2015 Jun;83(3):637-42. doi: 10.1037/ccp0000021. Epub 2015 Apr 20.
Background: PubMed 24131861Zipfel S, Wild B, Gross G, Friederich HC, Teufel M, Schellberg D, Giel KE, de Zwaan M, Dinkel A, Herpertz S, Burgmer M, Lowe B, Tagay S, von Wietersheim J, Zeeck A, Schade-Brittinger C, Schauenburg H, Herzog W; ANTOP study group. Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in outpatients with anorexia nervosa (ANTOP study): randomised controlled trial. Lancet. 2014 Jan 11;383(9912):127-37. doi: 10.1016/S0140-6736(13)61746-8. Epub 2013 Oct 14.
Background: PubMed 11952185Wilson GT, Fairburn CC, Agras WS, Walsh BT, Kraemer H. Cognitive-behavioral therapy for bulimia nervosa: time course and mechanisms of change. J Consult Clin Psychol. 2002 Apr;70(2):267-74.
Background: PubMed 28712432Westwood H, Kerr-Gaffney J, Stahl D, Tchanturia K. Alexithymia in eating disorders: Systematic review and meta-analyses of studies using the Toronto Alexithymia Scale. J Psychosom Res. 2017 Aug;99:66-81. doi: 10.1016/j.jpsychores.2017.06.007. Epub 2017 Jun 11.
Background: PubMed 23436476Watson HJ, Fursland A, Byrne S. Treatment engagement in eating disorders: who exits before treatment? Int J Eat Disord. 2013 Sep;46(6):553-9. doi: 10.1002/eat.22085. Epub 2013 Feb 25.
Background: PubMed 26057573Treasure J, Cardi V, Leppanen J, Turton R. New treatment approaches for severe and enduring eating disorders. Physiol Behav. 2015 Dec 1;152(Pt B):456-65. doi: 10.1016/j.physbeh.2015.06.007. Epub 2015 Jun 6.
Background: PubMed 18240125Treasure J, Sepulveda AR, MacDonald P, Whitaker W, Lopez C, Zabala M, Kyriacou O, Todd G. The assessment of the family of people with eating disorders. Eur Eat Disord Rev. 2008 Jul;16(4):247-55. doi: 10.1002/erv.859.
Background: PubMed 26649812Thompson-Brenner H, Shingleton RM, Thompson DR, Satir DA, Richards LK, Pratt EM, Barlow DH. Focused vs. Broad enhanced cognitive behavioral therapy for bulimia nervosa with comorbid borderline personality: A randomized controlled trial. Int J Eat Disord. 2016 Jan;49(1):36-49. doi: 10.1002/eat.22468. Epub 2015 Dec 9.
Background: PubMed 21820388Tatham M. The role of imagery-based techniques in cognitive-behavioural therapy for adults with eating disorders. Clin Psychol Rev. 2011 Nov;31(7):1101-9. doi: 10.1016/j.cpr.2011.06.008. Epub 2011 Jul 19.
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Individual participant dataSharing planned: Yes. Outcomes, age, gender

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giancarlo Dimaggio study chair

Centro di Terapia Metacognitiva Interpersonale, Roma

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MIT-ED in people with Eating Disorders and Maladaptive Personality Trait, run by GLORIA FIORAVANTI at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06693089, which also lists 61 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.