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
|Condition or disease|
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|
|Estimated Enrollment :||118 participants|
|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|
- Good BMI outcome [ Time Frame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge) ]Body Mass Index >= 18.5 kg/m2
- 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)
- 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.
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
|Contact: Riccardo Dalle Grave, MD||0039 3484120680 ext firstname.lastname@example.org|
|Contact: Simona Calugi, PhD||0039 3484120680 ext email@example.com|
|Department of Eating and Weight Disorders, Villa Garda Hospital||Recruiting|
|Garda, Italy, 37016|
|Contact: Riccardo Dalle Grave, MD 0039 3484120680 ext 0039 firstname.lastname@example.org|
|Principal Investigator:||Riccardo Dalle Grave, MD||Department of Eating and Weight Disorders, Villa Garda Hospital|