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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
Villa Garda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

13 Years - 65 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
May 25, 2012
Last Updated
October 6, 2020
Sponsor
Villa Garda Hospital
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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.
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Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

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