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Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa (RePAN)

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ClinicalTrials.gov Identifier: NCT01611220
Recruitment Status : Unknown
Verified December 2015 by Riccardo Dalle Grave, Villa Garda Hospital.
Recruitment status was:  Recruiting
First Posted : June 4, 2012
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Riccardo Dalle Grave, 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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: RePAN Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial
Study Start Date : June 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
No Intervention: Control
Standard cognitive behavior inpatient treatment
Experimental: RePAN
Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups
Behavioral: RePAN
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



Primary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: 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 :
  1. Eating disorder Examination (EDE) [ Time Frame: 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.



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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611220


Contacts
Contact: Riccardo Dalle Grave, MD 0039 3484120680 ext 0039 rdalleg@tin.it
Contact: Elisa Chignola, Psych 0039 3402780196 ext 0039 elisachignola@yahoo.it

Locations
Italy
Villa Garda Hospital Recruiting
Garda, Verona, Italy, 37016
Contact: Riccardo Dalle Grave, MD    0039 3484120680 ext 0039    r.dalleg@tin.it   
Contact: Elisa Chignola, Psych    0039 3402780196 ext 0039    elisachignola@yahoo.it   
Principal Investigator: Riccardo Dalle Grave, MD         
Sponsors and Collaborators
Villa Garda Hospital
Investigators
Principal Investigator: Riccardo Dalle Grave, MD Department of Eating and Weight Disorders, Villa Garda Hospital

Publications:
Responsible Party: Riccardo Dalle Grave, Head of Department of Eating and Weight Disorders, Villa Garda Hospital
ClinicalTrials.gov Identifier: NCT01611220     History of Changes
Other Study ID Numbers: USL22#03/12-CEP329
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Riccardo Dalle Grave, Villa Garda Hospital:
Anorexia Nervosa
Relapse prevention
Cognitive Dissonance
Inpatient treatment
Cognitive behavior therapy

Additional relevant MeSH terms:
Recurrence
Anorexia
Anorexia Nervosa
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders