Anorexia NervosaNCT04046926
Relapse in Anorexia Nervosa. A Cohort Study
An observational study of Anorexia Nervosa, run by Villa Garda Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 years, women only
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Female
- Age >= 13 years and <= 65 years
- Meeting diagnostic criteria for anorexia nervosa at inpatient admission
- 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
- Written informed consent
Who cannot join
- Acute psychotic disorders
- Active substance abuse
- Meeting diagnostic criteria for bulimia nervosa
- Medical complication that may hamper the interpretation of results (medical condition that causes weight changes)
- Absence of medical treatment (drugs) that may hamper the interpretation of results
- Pregnancy or plan to get pregnant
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Eating and Weight Disorders, Villa Garda Hospital
Garda, Italy, 37016
About this study
Official title: 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.
Read the 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
- Keywords
- anorexia nervosa, relapse, inpatient, cognitive behavioral therapy, prospective study
- Medical subject headings
- Anorexia Nervosa, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Good BMI outcome
Body Mass Index >= 18.5 kg/m2
Measured: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)
Secondary outcomes (2)
Relapse
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)
Measured: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)
Full Response
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.
Measured: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 May 2020
- Primary completion1 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Garda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Dalle Grave, Villa Garda Hospital
- Investigators
- Riccardo Dalle Grave, MD, Principal investigator, Department of Eating and Weight Disorders, Villa Garda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046926
- Sponsor's protocol ID
- VillaGH
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2018
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30113325Bardone-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.
PubMed 19945094
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapse in Anorexia Nervosa: a Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT04046926
- Acronym / sponsor ID
- VillaGH
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, relapse, inpatient, cognitive behavioral therapy, prospective study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Villa Garda HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- Female
- Age >= 13 years and <= 65 years
- Meeting diagnostic criteria for anorexia nervosa at inpatient admission
- 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
- Written informed consent
Key exclusion criteria (6 listed)
- Acute psychotic disorders
- Active substance abuse
- Meeting diagnostic criteria for bulimia nervosa
- Medical complication that may hamper the interpretation of results (medical condition that causes weight changes)
- Absence of medical treatment (drugs) that may hamper the interpretation of results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Good BMI outcome
Time frame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)
Body Mass Index >= 18.5 kg/m2
2 secondary outcomes
Relapse
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 30113325Berends 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.
- Background: PubMed 19945094Bardone-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riccardo Dalle Grave, MD principal investigator
Department of Eating and Weight Disorders, Villa Garda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Villa Garda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good BMI outcome (time frame: 40 weeks after inpatient admission (corresponding to 20 weeks after discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04046926, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.