Relapse in Anorexia Nervosa. A Cohort Study

April 27, 2022 updated by: Riccardo Dalle Grave, Villa Garda Hospital

Relapse in Anorexia Nervosa: a Prospective Longitudinal Study

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Riccardo Dalle Grave, MD
  • Phone Number: 0039 0039 3484120680
  • Email: rdalleg@gmail.com

Study Contact Backup

Study Locations

  • Italy
      • Garda, Italy, 37016
        • Recruiting
        • Department of Eating and Weight Disorders, Villa Garda Hospital
        • Contact:
          • Riccardo Dalle Grave, MD
          • Phone Number: 0039 0039 3484120680
          • Email: rdalleg@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Good BMI outcome
Time Frame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)
Body Mass Index >= 18.5 kg/m2
40 weeks after inpatient admission (corresponding to 20 weeks after discharge)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse
Time Frame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)

To evaluate the relapse, investigators need to consider patients with full response at discharge of inpatient treatment (i.e. after 20 weeks from admission) that relapse during the following 20 weeks (i.e 40 weeks after inpatient admission).

So, the criteria for the relapse are:

  • full response after 20 weeks of inpatient treatment AND
  • underweight BMI (i.e. BMI < 18.5 kg/m2) AND/OR
  • high level of eating disorder psychopathology (i.e. EDE-Q ≥ 2.77)
40 weeks after inpatient admission (corresponding to 20 weeks after discharge)
Full Response
Time Frame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)

To evaluate the full response in underweight eating disorder patients the investigators need to evaluate both the reaching a non-underweight BMI and an eating disorder psychopathology similar to non-clinical cases.

To evaluate the eating disorder psychopathology the investigators used the Eating Disorder Examination Questionnaire (EDE-Q). The EDE-Q global score range from 0 to 6.

The criteria for the Full Response are the following:

  • Body Mass Index >= 18.5 kg/m2 AND
  • Eating Disorder Examination Questionnaire (EDE-Q) global score < 2.77.
40 weeks after inpatient admission (corresponding to 20 weeks after discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Villa Garda Hospital

Investigators

  • Principal Investigator: Riccardo Dalle Grave, MD, Department of Eating and Weight Disorders, Villa Garda Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

August 3, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VillaGH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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