The ITA Model of Integrated Treatment of Eating Disorders

NCT04127214 | Active Not Recruiting

• 1 other identifier: FBG309562
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 8

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Change in Bulimic Investigatory Test, Edinburgh (BITE)

  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)

  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.

Interventions

ITA Integrated Treatment OTHER

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.

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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".

You may not qualify if:

• Not willing to participate (not signing informed consent).

Sponsors & Collaborators

• University of Barcelona: lead
• ITA salud mental: collaborator

Study Sites (8)

ITA salud mental-Argentona

Argentona, Catalonia, 08310, Spain

Location

ITA salud mental-Avenir

Barcelona, Catalonia, 08006, Spain

Location

ITA saklud mental-Urgell

Barcelona, Catalonia, 08036, Spain

Location

ITA salud mental-Sabadell

Barcelona, Catalonia, 08202, Spain

Location

ITA saludmental-Tarragona

Tarragona, Catalonia, 43003, Spain

Location

ITA salud mental-Moscatelar

Madrid, 28043, Spain

Location

ITA salud mental-Alcalá

Madrid, 28806, Spain

Location

ITA salud mental-ABB Sevilla Vidrio

Seville, 41003, Spain

Location

Related Publications (1)

• 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.

  PMID: 34006027 DERIVED

Related 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

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Bulimia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia

Study Officials

• Guillem Feixas, PhD

  Universitat de Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Antoni Grau-Touriño, Psychologist

  ITA salud mental, Spain

  STUDY DIRECTOR

• Chris Evans, MD

  University of Sheffield, UK

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 15, 2019
• Study Start: November 2, 2017
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

ES (8)