Eating DisordersITAMITEDNCT04127214
The ITA Model of Integrated Treatment of Eating Disorders
An observational study of Eating Disorders and Anorexia Nervosa, run by University of Barcelona at 8 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- ITA Integrated Treatment
- How many people
- 800 participants
- Where
- 8 sitesSpain
- Study dates
- 2 Nov 2017to 31 Oct 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with eating disorders undergoing treatment at "ITA salud mental".
Who may be able to join
- 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".
Who cannot join
- Not willing to participate (not signing informed consent).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
ITA salud mental-Argentona
Argentona, Catalonia, 08310
ITA salud mental-Avenir
Barcelona, Catalonia, 08006
ITA saklud mental-Urgell
Barcelona, Catalonia, 08036
ITA salud mental-Sabadell
Barcelona, Catalonia, 08202
ITA salud mental-Moscatelar
Madrid, Madrid, 28043
ITA salud mental-Alcalá
Madrid, Madrid, 28806
ITA salud mental-ABB Sevilla Vidrio
Seville, Sevilla, 41003
ITA saludmental-Tarragona
Tarragona, Catalonia, 43003
About this study
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.
Read the 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.
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge Eating, Eating Disorders in Adolescence, Eating and Feeding Disorders
- Being tested
- ITA Integrated Treatment
- Keywords
- eating disorders, anorexia nervosa, bulimia nervosa, binge eating, routine outcome monitoring, psychological interventions, integrated treatment, effectiveness
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITA Integrated TreatmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical outcomes in routine evaluation outcome measure (CORE-OM)
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.
Measured: 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)
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.
Measured: EAT is administered at baseline, at one week, and then routinely every three months until study completion.
Secondary outcomes (2)
Change in Bulimic Investigatory Test, Edinburgh (BITE)
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.
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start2 Nov 2017
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- ITA salud mental
- Responsible party
- Principal investigator, Dr. Guillem Feixas, University of Barcelona
- Investigators
- Guillem Feixas, PhD, Principal investigator, Universitat de Barcelona, SpainAntoni Grau-Touriño, Psychologist, Study director, ITA salud mental, SpainChris Evans, MD, Study chair, University of Sheffield, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127214
- Sponsor's protocol ID
- FBG309562
- Acronym
- ITAMITED
- Status last verified
- Jul 2026
- First submitted
- 1 Oct 2019
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34006027
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ITA Model of Integrated Treatment of Eating Disorders
- ClinicalTrials.gov ID
- NCT04127214
- Acronym / sponsor ID
- ITAMITED / FBG309562
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge Eating, Eating Disorders in Adolescence, Eating and Feeding Disorders
- Keywords
- eating disorders, anorexia nervosa, bulimia nervosa, binge eating, routine outcome monitoring, psychological interventions, integrated treatment, effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- ITA salud mental
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 15 Oct 2019 (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.
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
"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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with eating disorders undergoing treatment at "ITA salud mental".
Key inclusion criteria (2 listed)
- 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".
Key exclusion criteria (1 listed)
- Not willing to participate (not signing informed consent).
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 |
|---|---|---|
| ITA Integrated TreatmentThe 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. | Other | – |
Primary outcome
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.
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 34006027Grau 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.
- Research group on Intervention in Clinical and Health Psychology (recognized by the "Generalitat de Catalunya")Link provided by the sponsor.
- Web site of "ITA salud mental" the institution in which the study is conductedLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Guillem Feixas, PhD principal investigator
Universitat de Barcelona, Spain
Antoni Grau-Touriño, Psychologist study director
ITA salud mental, Spain
Chris Evans, MD study chair
University of Sheffield, UK
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders and Anorexia Nervosa, run by University of Barcelona at 8 sites in Spain.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 NCT04127214, which also lists 1 linked publication.
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 7 Jul 2026.