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Completed

NCT Number: NCT01611220

Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

13 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Villa Garda Hospital

Garda, Verona, 37016, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RePAN

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

Other names: Dissonance relapse prevention

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: 1 year

    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 outcomes

  1. Eating disorder Examination (EDE)

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Villa Garda Hospital

Other

Registry information

Official study title

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

Acronym: RePAN

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2012
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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