Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa (RePAN)
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
RePAN
Sponsored by
About this trial
This is an interventional prevention trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Relapse prevention, Cognitive Dissonance, Inpatient treatment, Cognitive behavior therapy
Eligibility 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
Sites / Locations
- Villa Garda Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
RePAN
Arm Description
Standard cognitive behavior inpatient treatment
Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01611220
Brief Title
Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa
Acronym
RePAN
Official Title
Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Villa Garda Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia Nervosa, Relapse prevention, Cognitive Dissonance, Inpatient treatment, Cognitive behavior therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard cognitive behavior inpatient treatment
Arm Title
RePAN
Arm Type
Experimental
Arm Description
Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups
Intervention Type
Behavioral
Intervention Name(s)
RePAN
Other Intervention Name(s)
Dissonance relapse prevention
Intervention Description
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
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Eating disorder Examination (EDE)
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riccardo Dalle Grave, MD
Organizational Affiliation
Department of Eating and Weight Disorders, Villa Garda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Villa Garda Hospital
City
Garda
State/Province
Verona
ZIP/Postal Code
37016
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
18377128
Citation
Stice E, Marti CN, Spoor S, Presnell K, Shaw H. Dissonance and healthy weight eating disorder prevention programs: long-term effects from a randomized efficacy trial. J Consult Clin Psychol. 2008 Apr;76(2):329-40. doi: 10.1037/0022-006X.76.2.329.
Results Reference
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Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa
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