Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

Not Applicable

Completed

• Conditions: Anorexia Nervosa

• Registration Number: NCT01611220
• Lead Sponsor: Villa Garda Hospital

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.

Study Timeline

• Study First Submitted: 2012-05-25
• Study First Submitted QC: 2012-05-30
• Study Start: 2012-06
• Study First Posted: 2012-06-04
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Eating disorder Examination (EDE)	1 year	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.

Trial Locations

Locations (1)

Villa Garda Hospital; 🇮🇹 Garda, Verona, Italy