Clinical trial NCT04127214: The ITA Model of Integrated Treatment of Eating Disorders
Official title: The ITA Model of Integrated Treatment of Eating Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: ITA salud mental
First posted: 2019-10-15
Enrollment: 800
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with eating disorders undergoing treatment at "ITA salud mental".

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Clinical outcomes in routine evaluation outcome measure (CORE-OM)
timeFrame: 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.
measure: Change in Eating Attitudes Test (EAT)
timeFrame: EAT is administered at baseline, at one week, and then routinely every three months until study completion.
Secondary outcomes:
measure: Change in Bulimic Investigatory Test, Edinburgh (BITE)
timeFrame: BITE is administered at baseline, at one week, and then routinely every three months until 30th. of October, 2020.
measure: Change in Body Mass Index (BMI)
timeFrame: 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.
Other outcomes:
Locations:
city: Argentona
country: Spain
facility: ITA salud mental-Argentona
state: Catalonia
city: Barcelona
country: Spain
facility: ITA salud mental-Avenir
state: Catalonia
city: Barcelona
country: Spain
facility: ITA saklud mental-Urgell
state: Catalonia
city: Barcelona
country: Spain
facility: ITA salud mental-Sabadell
state: Catalonia
city: Tarragona
country: Spain
facility: ITA saludmental-Tarragona
state: Catalonia
city: Madrid
country: Spain
facility: ITA salud mental-Moscatelar
city: Madrid
country: Spain
facility: ITA salud mental-Alcalá
city: Sevilla
country: Spain
facility: ITA salud mental-ABB Sevilla Vidrio
Study officials:
affiliation: Universitat de Barcelona, Spain
name: Guillem Feixas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ITA salud mental, Spain
name: Antoni Grau-Touriño, Psychologist
role: STUDY_DIRECTOR
affiliation: University of Sheffield, UK
name: Chris Evans, MD
role: STUDY_CHAIR
References:
citation: 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.