Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa (RePAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Villa Garda Hospital
Sponsor:
Information provided by (Responsible Party):
Riccardo Dalle Grave, Villa Garda Hospital
ClinicalTrials.gov Identifier:
NCT01611220
First received: May 25, 2012
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Anorexia Nervosa
Behavioral: RePAN
Phase 2

Study Type: Interventional
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

Further study details as provided by Villa Garda Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
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)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   13 Years to 65 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: May 25, 2012
Last Updated: June 27, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014