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CompletedNCT01611220RePANUpdated Oct 8, 2020

Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

An interventional study of RePAN in Anorexia Nervosa, sponsored by Villa Garda Hospital. Completed at 1 site in Italy. Open to female participants aged 13 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by Villa Garda Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
13 Years to 65 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Anorexia Nervosa

Keywords

  • Anorexia Nervosa
  • Relapse prevention
  • Cognitive Dissonance
  • Inpatient treatment
  • Cognitive behavior therapy
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In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 80 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Villa Garda Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female
  • Body Mass Index ≥ 18.5
  • Anorexia Nervosa patients admitted to inpatient treatment
  • Written informed consent

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • No intervention
    Control

    Standard cognitive behavior inpatient treatment

  • Experimental
    RePAN

    Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups

    Behavioral: RePAN

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

    Also known as: Dissonance relapse prevention

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

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Study locations

1 site
  • Villa Garda Hospital
    Garda, Verona 37016, Italy
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References and documents

Publications

  • 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. PubMed 18377128 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01611220
Lead sponsor
Villa Garda Hospital
Responsible party
Riccardo Dalle Grave (Head of Department of Eating and Weight Disorders, Villa Garda Hospital) — Principal investigator
First posted
Jun 4, 2012
Start date
Jun 2012
Primary completion
Oct 2018
Completion
Oct 2018
Last update
Oct 8, 2020

Study contacts

Riccardo Dalle Grave, MD
principal investigator · Department of Eating and Weight Disorders, Villa Garda Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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