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

November 30, 2023 updated by: Dr. Guillem Feixas, University of Barcelona
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28043
        • ITA salud mental-Moscatelar
      • Madrid, Spain, 28806
        • ITA salud mental-Alcalá
      • Sevilla, Spain, 41003
        • ITA salud mental-ABB Sevilla Vidrio
    • Catalonia
      • Argentona, Catalonia, Spain, 08310
        • ITA salud mental-Argentona
      • Barcelona, Catalonia, Spain, 08006
        • ITA salud mental-Avenir
      • Barcelona, Catalonia, Spain, 08036
        • ITA saklud mental-Urgell
      • Barcelona, Catalonia, Spain, 08202
        • ITA salud mental-Sabadell
      • Tarragona, Catalonia, Spain, 43003
        • ITA saludmental-Tarragona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with eating disorders undergoing treatment at "ITA salud mental".

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
EAT is administered at baseline, at one week, and then routinely every three months until study completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
BITE is administered at baseline, at one week, and then routinely every three months until 30th. of October, 2020.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Collaborators

ITA salud mental

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2017

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FBG309562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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