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Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01611220
Acronym
RePAN
Enrollment
80
Registered
2012-06-04
Start date
2012-06-30
Completion date
2018-10-31
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Keywords

Anorexia Nervosa, Relapse prevention, Cognitive Dissonance, Inpatient treatment, Cognitive behavior therapy

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.

Interventions

BEHAVIORALRePAN

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

Sponsors

Villa Garda Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body Mass Index (BMI)1 yearThe 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

MeasureTime frameDescription
Eating disorder Examination (EDE)1 yearNumber 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026