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Relapse in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT04046926
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Riccardo Dalle Grave, Villa Garda Hospital

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.

Condition or disease
Anorexia Nervosa

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.


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Study Type : Observational
Estimated Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relapse in Anorexia Nervosa: a Prospective Longitudinal Study
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022



Primary Outcome Measures :
  1. Good BMI outcome [ Time Frame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge) ]
    Body Mass Index >= 18.5 kg/m2


Secondary Outcome Measures :
  1. 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)

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046926


Contacts
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Contact: Riccardo Dalle Grave, MD 0039 3484120680 ext 0039 rdalleg@gmail.com
Contact: Simona Calugi, PhD 0039 3484120680 ext 0039 si.calugi@gmail.com

Locations
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Italy
Department of Eating and Weight Disorders, Villa Garda Hospital Recruiting
Garda, Italy, 37016
Contact: Riccardo Dalle Grave, MD    0039 3484120680 ext 0039    rdalleg@gmail.com   
Sponsors and Collaborators
Villa Garda Hospital
Investigators
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Principal Investigator: Riccardo Dalle Grave, MD Department of Eating and Weight Disorders, Villa Garda Hospital

Publications:
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Responsible Party: Riccardo Dalle Grave, Director of the Department of Eating and Weight Disorders, Villa Garda Hospital
ClinicalTrials.gov Identifier: NCT04046926     History of Changes
Other Study ID Numbers: VillaGH
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riccardo Dalle Grave, Villa Garda Hospital:
anorexia nervosa
relapse
inpatient
cognitive behavioral therapy
prospective study
Additional relevant MeSH terms:
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Recurrence
Anorexia
Anorexia Nervosa
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders