Clinical trial NCT01611220: Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa
Official title: Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Relapse prevention
Cognitive Dissonance
Inpatient treatment
Cognitive behavior therapy
Lead sponsor: Villa Garda Hospital
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 1 year
Secondary outcomes:
measure: Eating disorder Examination (EDE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Garda
country: Italy
facility: Villa Garda Hospital
state: Verona
Study officials:
affiliation: Department of Eating and Weight Disorders, Villa Garda Hospital
name: Riccardo Dalle Grave, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.