Anorexia Nervosa Clinical Trial
— ITAMITEDOfficial title:
The ITA Model of Integrated Treatment of Eating Disorders
Verified date | November 2023 |
Source | University of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Barcelona | ITA salud mental |
Spain,
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. |
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