NCT01611220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

6.3 years

First QC Date

May 25, 2012

Last Update Submit

October 6, 2020

Conditions

Keywords

Anorexia NervosaRelapse preventionCognitive DissonanceInpatient treatmentCognitive behavior therapy

Outcome Measures

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.

    1 year

Secondary Outcomes (1)

  • Eating disorder Examination (EDE)

    1 year

Study Arms (2)

Control

NO INTERVENTION

Standard cognitive behavior inpatient treatment

RePAN

EXPERIMENTAL

Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups

Behavioral: RePAN

Interventions

RePANBEHAVIORAL

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
RePAN

Eligibility Criteria

Age13 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Villa Garda Hospital

Garda, Verona, 37016, Italy

Location

Related 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.

    PMID: 18377128BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Riccardo Dalle Grave, MD

    Department of Eating and Weight Disorders, Villa Garda Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Eating and Weight Disorders

Study Record Dates

First Submitted

May 25, 2012

First Posted

June 4, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations