Relapse in Anorexia Nervosa. A Cohort Study

NCT04046926 | Completed

• 1 other identifier: VillaGH
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The hospitalization in patients with anorexia nervosa has often a short-term success, as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. Starting from the observation that the relapse rate is lower in outpatient than in inpatient settings, the investigators hypothesized that the reason of this difference is the nature of inpatient treatment and post-inpatient therapy. For this reason, different procedures and strategies have been implemented during hospitalization to reduce the relapse after discharge. The aim of the study was to assess the time and the percentage of relapse after inpatient discharge and at follow-up.

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa; relapse; inpatient; cognitive behavioral therapy; prospective study

Outcome Measures

Primary Outcomes (1)

• Good BMI outcome

  Body Mass Index \>= 18.5 kg/m2

  40 weeks after inpatient admission (corresponding to 20 weeks after discharge)

Secondary Outcomes (2)

• Relapse

  40 weeks after inpatient admission (corresponding to 20 weeks after discharge)

• Full Response

  40 weeks after inpatient admission (corresponding to 20 weeks after discharge)

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The sample includes patients with anorexia nervosa who will be recruited from consecutive referrals to the eating disorder inpatient unit of Villa Garda Hospital (Northern Italy).

You may qualify if:

• Female
• Age \>= 13 years and \<= 65 years
• Meeting diagnostic criteria for anorexia nervosa at inpatient admission
• Full response (i.e., Body Mass Index (BMI) \>= 18.5 kg/m2 and Eating Disorder Examination Questionnaire (EDE-Q) global score \< 2.77) at discharge
• Written informed consent

You may not qualify if:

• Acute psychotic disorders
• Active substance abuse
• Meeting diagnostic criteria for bulimia nervosa
• Medical complication that may hamper the interpretation of results (medical condition that causes weight changes)
• Absence of medical treatment (drugs) that may hamper the interpretation of results
• Pregnancy or plan to get pregnant

Sponsors & Collaborators

• Villa Garda Hospital: lead

Study Sites (1)

Department of Eating and Weight Disorders, Villa Garda Hospital

Garda, Italy, 37016, Italy

Location

Related Publications (2)

• Berends T, Boonstra N, van Elburg A. Relapse in anorexia nervosa: a systematic review and meta-analysis. Curr Opin Psychiatry. 2018 Nov;31(6):445-455. doi: 10.1097/YCO.0000000000000453.

  PMID: 30113325 BACKGROUND

• Bardone-Cone AM, Harney MB, Maldonado CR, Lawson MA, Robinson DP, Smith R, Tosh A. Defining recovery from an eating disorder: Conceptualization, validation, and examination of psychosocial functioning and psychiatric comorbidity. Behav Res Ther. 2010 Mar;48(3):194-202. doi: 10.1016/j.brat.2009.11.001. Epub 2009 Nov 13.

  PMID: 19945094 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa; Recurrence

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Riccardo Dalle Grave, MD

  Department of Eating and Weight Disorders, Villa Garda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Eating and Weight Disorders

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: August 6, 2019
• Study Start: May 1, 2020
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

IT (1)