Relapse in Anorexia Nervosa. A Cohort Study

NCT ID: NCT04046926

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

Anorexia nervosa is considered one of the most difficult to treat mental disorders and often treatment outcomes are unsatisfactory. Outpatient treatment is the ideal choice for the treatment of anorexia nervosa, but a large subgroup of patients (50-60%) does not respond to outpatient treatments and need more intensive care, such as hospital rehabilitation. The hospitalization 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. Strategies to limit the post-hospitalization relapse rate are now focused on assessing the effectiveness of different treatments given after discharge. Our group, after evaluating the results of a controlled study, used another strategy. 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 primary outcome of interest is the proportion of patients who relapse after discharge from hospitalization. For the calculation of the sample size a 95% confidence interval was established, an expected prevalence of 40% and a desired accuracy of 10%. Based on these premises, it is necessary to have a group of "completers" at 60 weeks of follow-up of 92 patients. To calculate the initial sample needed to generate 92 patients at 60 weeks of follow-up, the investigators considered the attrition rate during treatment (set at 13%) and a subsequent attrition rate at follow-ups (set at 10%). This calculation produces a result of an initial sample of 118 patients.

The frequency and time of relapse will be evaluated using Kaplan-Meier survival analysis. Cox proportional hazards regression analysis will be used to examine the role of predictive variables in predicting time to relapse. Univariate Cox regressions and multivariate Cox regressions will be used to evaluate the potentially predictive variables at baseline, during the treatment process, at the end of therapy and during post-discharge.

Conditions

Anorexia Nervosa

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Female

2. Age >= 13 years and <= 65 years

3. Meeting diagnostic criteria for anorexia nervosa at inpatient admission

4. 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

5. Written informed consent

Exclusion Criteria

1. Acute psychotic disorders

2. Active substance abuse

3. Meeting diagnostic criteria for bulimia nervosa

4. Medical complication that may hamper the interpretation of results (medical condition that causes weight changes)

5. Absence of medical treatment (drugs) that may hamper the interpretation of results

6. Pregnancy or plan to get pregnant

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Villa Garda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Riccardo Dalle Grave

Director of the Department of Eating and Weight Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Riccardo Dalle Grave, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Eating and Weight Disorders, Villa Garda Hospital

Locations

Department of Eating and Weight Disorders, Villa Garda Hospital

Garda, Italy, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 30113325 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19945094 (View on PubMed)

Other Identifiers

VillaGH

Identifier Type: -

Identifier Source: org_study_id