Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Behavioral: RePAN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard cognitive behavior inpatient treatment | |
| Experimental: RePAN<br>Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups | Behavioral: RePAN<br>* 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<br>* Other names: Dissonance relapse prevention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating disorder Examination (EDE) | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia Nervosa, Relapse prevention, Cognitive Dissonance, Inpatient treatment, Cognitive behavior therapy