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The ITA Model of Integrated Treatment of Eating Disorders (ITAMITED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04127214
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : September 21, 2020
ITA salud mental
Information provided by (Responsible Party):
Dr. Guillem Feixas, University of Barcelona

Brief Summary:
This is a naturalistic study implementing a routine assessment to monitor the evolution of the patients with eating disorders being treated in various centers of "ITA salud mental" in Spain.

Condition or disease Intervention/treatment
Eating Disorders Anorexia Nervosa Bulimia Nervosa Binge Eating Eating Disorders in Adolescence Eating and Feeding Disorders Other: ITA Integrated Treatment

Detailed Description:

"ITA salud mental" offers integrated treatment for eating disorders including outpatient, inpatient and day hospital care. The routine assessment implemented to this aim includes both general measures to gauge the therapeutic progress (CORE system) and measures specific for eating disorders (EAT, BITE), which are administered from the beginning to the end of treatment in different time points combined with clinical data included in the patients' health record such as diagnosis, body mass index, previous treatments, and chronicity.

According to its naturalistic nature, this study will accept all participants who are admitted into the care system offered by "ITA salud mental" between November 2, 2017 and October, 2nd., 2020, meeting the inclusion/exclusion criteria and signing informed consent (n = 800 is an estimation). These patients will be followed on three-week bases until October, 30th., 2020, and less intensively on three-month bases until October 2025 to monitor symptoms and to record possible adverse effects.

The analysis of these data will permit to evaluate the therapeutic effects of this integrated treatment and the factors which might influence the outcomes.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The ITA Model of Integrated Treatment of Eating Disorders
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : October 31, 2025

Intervention Details:
  • Other: ITA Integrated Treatment
    The ITA Model combines outpatient intervention (mainly psychotherapy), day hospital care and hospitalization as a function of patients' characteristics. Case conceptualization of the psychological processes of patients is formulated and revised within a team including psychologists, psychotherapists, psychiatrists, nutritionists, physicians, nurses, and social workers. The major emphasis of the ITA model is on psychological interventions which include individual psychotherapy, family therapy and/or guidance, and group therapy of various formats and contents (e.g., drug abuse, mindfulness, emotion work) tailored to the needs of each patient. However, when required, drugs are prescribed adjusting type of medication and dosage to the need of the patient.

Primary Outcome Measures :
  1. Change in Clinical outcomes in routine evaluation outcome measure (CORE-OM) [ Time Frame: CORE-OM is administered at baseline, at one week, and then routinely every three months (using A and B short forms alternatively every three weeks until October 30th, 2020) until study completion. ]
    CORE-OM is a 34-item self-report questionnaire for the assessment of subjective well-being, symptoms or problems, life functioning, and risk. It has good psychometric properties and it has been validated for the Spanish population. Its transdiagnostic nature makes it suitable for all kinds of eating disorders especially if we take into account the frequent comorbidities with other mental disorders (e.g., depression, anxiety) of these patients. Short forms of this questionnaire (versions A and B) are used to monitor patients' progress.

  2. Change in Eating Attitudes Test (EAT) [ Time Frame: EAT is administered at baseline, at one week, and then routinely every three months until study completion. ]
    The EAT (children and adult versions) is a 26-item standardized self-report questionnaire devised to measure symptoms and concerns characteristic of eating disorders. Although the EAT has been used as a screening tool, here it is used to gauge symptom severity. It has good psychometric properties and it has been validated for the Spanish population.

Secondary Outcome Measures :
  1. Change in Bulimic Investigatory Test, Edinburgh (BITE) [ Time Frame: BITE is administered at baseline, at one week, and then routinely every three months until 30th. of October, 2020. ]
    BITE is a 33-item standardized self-report questionnaire measuring eating disorders symptoms and severity. It is especially suited for binge eating disorders and bulimia nervosa. The test is well sensitive to measure the effectiveness of the therapy and the changes of symptoms. It has good psychometric properties and it has been validated for the Spanish population.

  2. Change in Body Mass Index (BMI) [ Time Frame: Patients' weight and height is recorded at baseline and then weight every month (every thee-months after October 30th, 2020) up to 5 years. No follow-up data will be collected for this measure. ]
    The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in meters. It is widely used for the assessment of therapeutic progress in eating disorders and obesity.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with eating disorders undergoing treatment at "ITA salud mental".

Inclusion Criteria:

  • Diagnosis of an eating disorder: Anorexia Nervosa, Bulimia Nervosa, Binge and other eating disorders Not Otherwise Specified.
  • Treated in one of the centers of "ITA salud mental".

Exclusion Criteria:

  • Not willing to participate (not signing informed consent).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04127214

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Contact: Antoni Grau-Touriño, Psychoiogist +34932530137
Contact: Montse Pascual-Roige, Psychologist +34932530137

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ITA salud mental-Argentona Recruiting
Argentona, Catalonia, Spain, 08310
Contact: Elena Cruz Baena, Psychology    937530062   
ITA salud mental-Avenir Recruiting
Barcelona, Catalonia, Spain, 08006
Contact: Elena Cruz Baena, Psychology    +34932530137   
ITA saklud mental-Urgell Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Marta Miguel Martínez, Psychology    931998415   
ITA salud mental-Sabadell Recruiting
Barcelona, Catalonia, Spain, 08202
Contact: Ricardo Pérez Martín, Psychology    937220855   
ITA saludmental-Tarragona Recruiting
Tarragona, Catalonia, Spain, 43003
Contact: Laura García Esteva, Psychology    977219634   
ITA salud mental-Moscatelar Recruiting
Madrid, Spain, 28043
Contact: Victoria Ramos Kurland, Psychology    911450683   
ITA salud mental-Alcalá Recruiting
Madrid, Spain, 28806
Contact: Andrea L. Barrios Hernández, Psychology    911450691   
ITA salud mental-ABB Sevilla Vidrio Recruiting
Sevilla, Spain, 41003
Contact: Daniel Brull Rodríguez, Psychology    954633252   
Sponsors and Collaborators
University of Barcelona
ITA salud mental
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Principal Investigator: Guillem Feixas, PhD Universitat de Barcelona, Spain
Study Director: Antoni Grau-Touriño, Psychologist ITA salud mental, Spain
Study Chair: Chris Evans, MD University of Sheffield, UK
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Guillem Feixas, Professor, University of Barcelona Identifier: NCT04127214    
Other Study ID Numbers: FBG309562
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Guillem Feixas, University of Barcelona:
eating disorders
anorexia nervosa
bulimia nervosa
binge eating
routine outcome monitoring
psychological interventions
integrated treatment
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Anorexia Nervosa
Binge-Eating Disorder
Bulimia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive