Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

NCT ID: NCT01611220

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-10-31

Brief Summary

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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

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Standard cognitive behavior inpatient treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

RePAN

Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups

Group Type EXPERIMENTAL

RePAN

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Dissonance relapse prevention

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Villa Garda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Riccardo Dalle Grave

Head of Department of Eating and Weight Disorders

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Riccardo Dalle Grave, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Eating and Weight Disorders, Villa Garda Hospital

Locations

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Villa Garda Hospital

Garda, Verona, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 18377128 (View on PubMed)

Other Identifiers

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USL22#03/12-CEP329

Identifier Type: -

Identifier Source: org_study_id

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