Clinical trial NCT04046926: Relapse in Anorexia Nervosa. A Cohort Study
Official title: Relapse in Anorexia Nervosa: a Prospective Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
relapse
inpatient
cognitive behavioral therapy
prospective study
Lead sponsor: Villa Garda Hospital
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 118
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Good BMI outcome
timeFrame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)
Secondary outcomes:
measure: Relapse
timeFrame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)
measure: Full Response
timeFrame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)
Other outcomes:
Locations:
city: Garda
country: Italy
facility: Department of Eating and Weight Disorders, Villa Garda Hospital
Study officials:
affiliation: Department of Eating and Weight Disorders, Villa Garda Hospital
name: Riccardo Dalle Grave, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.