The ITA Model of Integrated Treatment of Eating Disorders

Anorexia Nervosa Clinical Trial

— ITAMITED  

Official title:

The ITA Model of Integrated Treatment of Eating Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04127214
• Other study ID #: FBG309562
• Status: Active, not recruiting
• Start date: November 2, 2017
• Est. completion date: October 31, 2025

Study information

• Verified date: November 2023
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating and Feeding Disorders
• Eating Disorders
• Eating Disorders in Adolescence
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
Spain	ITA salud mental-Argentona	Argentona	Catalonia
Spain	ITA saklud mental-Urgell	Barcelona	Catalonia
Spain	ITA salud mental-Avenir	Barcelona	Catalonia
Spain	ITA salud mental-Sabadell	Barcelona	Catalonia
Spain	ITA salud mental-Alcalá	Madrid
Spain	ITA salud mental-Moscatelar	Madrid
Spain	ITA salud mental-ABB Sevilla Vidrio	Sevilla
Spain	ITA saludmental-Tarragona	Tarragona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
University of Barcelona	ITA salud mental

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	EAT is administered at baseline, at one week, and then routinely every three months until study completion.
Secondary	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.	BITE is administered at baseline, at one week, and then routinely every three months until 30th. of October, 2020.
Secondary	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.	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.

External Links

•   Research group on Intervention in Clinical and Health Psychology (recognized by the "Generalitat de Catalunya")
•   Web site of "ITA salud mental" the institution in which the study is conducted