Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— RePAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611220
• Other study ID #: USL22#03/12-CEP329
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: October 2018

Study information

• Verified date: October 2020
• Source: Villa Garda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Italy	Villa Garda Hospital	Garda	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Villa Garda Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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