Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa (RePAN)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial|
- Body Mass Index (BMI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]The main outcome is to assess the number of patients with good BMI outcome (BMI ≥ 18.5) at 12-month follow-up end in the two arm conditions.
- Eating disorder Examination (EDE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Number of patients with "full remission" defined as having a global EDE score below 1SD above the community mean (1.74) and a BMI ≥ 18.5.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
No Intervention: Control
Standard cognitive behavior inpatient treatment
Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups
The dissonance relapse prevention intervention consists of eight groups conducted by a psychologist who involves participants in interactive activities aimed to prevent relapse after discharge from the inpatient treatment
Other Name: Dissonance relapse prevention
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611220
|Contact: Riccardo Dalle Grave, MD||0039 3484120680 ext firstname.lastname@example.org|
|Contact: Elisa Chignola, Psych||0039 3402780196 ext email@example.com|
|Villa Garda Hospital||Recruiting|
|Garda, Verona, Italy, 37016|
|Contact: Riccardo Dalle Grave, MD 0039 3484120680 ext 0039 firstname.lastname@example.org|
|Contact: Elisa Chignola, Psych 0039 3402780196 ext 0039 email@example.com|
|Principal Investigator: Riccardo Dalle Grave, MD|
|Principal Investigator:||Riccardo Dalle Grave, MD||Department of Eating and Weight Disorders, Villa Garda Hospital|