Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa
Information source: Villa Garda Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia Nervosa
Intervention: RePAN (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: Villa Garda Hospital Official(s) and/or principal investigator(s):
Riccardo Dalle Grave, MD, Principal Investigator, Affiliation: Department of Eating and Weight Disorders, Villa Garda Hospital
Overall contact:
Riccardo Dalle Grave, MD, Phone: 0039 3484120680, Ext: 0039, Email: rdalleg@tin.it
Summary
Anorexia Nervosa inpatient treatment 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. The development of strategies to overcome this problem represents a priority
for clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program
based on cognitive dissonance theory developed for hospitalized patients.
Clinical Details
Official title: Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Body Mass Index (BMI)
Secondary outcome: Eating disorder Examination (EDE)
Detailed description:
Inpatient treatment for anorexia nervosa is often successful in restoring body weight, but a
high percentage of patients relapse following discharge. The aim of the study was to assess
the effect of a relapse prevention program during the last phase of inpatient treatment.
Patients, when they achieve a BMI of 18. 5, are randomly allocated to complete the standard
cognitive behavior inpatient treatment (CBT-I) or to complete the standard CBT-I plus eight
relapse prevention groups based on the cognitive dissonance. The intervention has been
derived by the selective and indicated prevention programs using a dissonance-based
approach. This intervention showed to be effective in reducing the risk for eating pathology
onset. The primary outcome of the study is to assess the number of patients allocated to the
two condition with a BMI equal or greater than 18. 5 at 12-months after discharge.
Eligibility
Minimum age: 13 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female
- Body Mass Index ≥ 18. 5
- Anorexia Nervosa patients admitted to inpatient treatment
- Written informed consent
Exclusion Criteria:
- Male
- Schizophrenia or other psychiatric disorders
- Substance abuse
- 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
Locations and Contacts
Riccardo Dalle Grave, MD, Phone: 0039 3484120680, Ext: 0039, Email: rdalleg@tin.it
Villa Garda Hospital, Garda, Verona 37016, Italy; Recruiting
Riccardo Dalle Grave, MD, Phone: 0039 3484120680, Ext: 0039, Email: r.dalleg@tin.it
Elisa Chignola, Psych, Phone: 0039 3402780196, Ext: 0039, Email: elisachignola@yahoo.it
Riccardo Dalle Grave, MD, Principal Investigator
Additional Information
Related publications: Stice E, Marti CN, Spoor S, Presnell K, Shaw H. Dissonance and healthy weight eating disorder prevention programs: long-term effects from a randomized efficacy trial. J Consult Clin Psychol. 2008 Apr;76(2):329-40. doi: 10.1037/0022-006X.76.2.329.
Starting date: June 2012
Last updated: June 1, 2015
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