The ITA Model of Integrated Treatment of Eating Disorders

NCT ID: NCT04127214

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-02

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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"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.

Conditions

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Eating Disorders Anorexia Nervosa Bulimia Nervosa Binge Eating Eating Disorders in Adolescence Eating and Feeding Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ITA salud mental

UNKNOWN

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Dr. Guillem Feixas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillem Feixas, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de Barcelona, Spain

Antoni Grau-Touriño, Psychologist

Role: STUDY_DIRECTOR

ITA salud mental, Spain

Chris Evans, MD

Role: STUDY_CHAIR

University of Sheffield, UK

Locations

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ITA salud mental-Argentona

Argentona, Catalonia, Spain

Site Status

ITA salud mental-Avenir

Barcelona, Catalonia, Spain

Site Status

ITA saklud mental-Urgell

Barcelona, Catalonia, Spain

Site Status

ITA salud mental-Sabadell

Barcelona, Catalonia, Spain

Site Status

ITA saludmental-Tarragona

Tarragona, Catalonia, Spain

Site Status

ITA salud mental-Moscatelar

Madrid, , Spain

Site Status

ITA salud mental-Alcalá

Madrid, , Spain

Site Status

ITA salud mental-ABB Sevilla Vidrio

Seville, , Spain

Site Status

Countries

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Spain

References

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Grau Tourino A, Feixas G, Medina JC, Paz C, Evans C. Effectiveness of integrated treatment for eating disorders in Spain: protocol for a multicentre, naturalistic, observational study. BMJ Open. 2021 Mar 8;11(3):e043152. doi: 10.1136/bmjopen-2020-043152.

Reference Type DERIVED
PMID: 34006027 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Related Links

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http://ub.edu/ipcs

Research group on Intervention in Clinical and Health Psychology (recognized by the "Generalitat de Catalunya")

http://itasaludmental.com

Web site of "ITA salud mental" the institution in which the study is conducted

Other Identifiers

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FBG309562

Identifier Type: -

Identifier Source: org_study_id

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