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Body Image Therapy in Anorexia Nervosa (PIPA)

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anamorphic Micro software
therapy as usual
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring anorexia nervosa, CMME-TCA Unit, Centre Hospitalier Sainte Anne

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • woman
  • more than 18 years old
  • anorexia nervosa
  • hospitalized in the CMME (CHSA) TCA Unit
  • Body Mass Index ≥ 16
  • Informed consent

Exclusion Criteria:

  • pregnancy
  • severe motor, sensitive or sensorial impairment
  • no affiliation of national health service
  • dependent of a trusteeship or guardianship

Sites / Locations

  • Centre Hospitalier Sainte Anne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional arm

control arm

Arm Description

Body image therapy with Anamorphic Micro software

Body image therapy as usual

Outcomes

Primary Outcome Measures

Body Shape Questionnaire
Body Shape Questionnaire Score after the 10 sessions of body image therapy

Secondary Outcome Measures

Full Information

First Posted
September 20, 2011
Last Updated
February 11, 2016
Sponsor
Centre Hospitalier St Anne
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1. Study Identification

Unique Protocol Identification Number
NCT01437527
Brief Title
Body Image Therapy in Anorexia Nervosa
Acronym
PIPA
Official Title
Body Image Therapy in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to test a new procedure of body image therapy in anorexia nervosa, using the anamorphic micro software.
Detailed Description
Anorexia nervosa is a severe psychiatric disorder, with high level of mortality and hospitalization is often necessary for the treatment of severe and/or chronic cases. Anorexic patients often experience a serious disturbance in body and their own shape perception. Body image work should be enhanced in the treatment of anorexia nervosa. The aim of the study is to test a new body image therapy using the anamorphic Micro software. Ten sessions of assessment of the patient's own shape and of correction of distorted perceptions of body size with Anamorphic Micro software will be compared to ten sessions of body image therapy as usual. French 100 anorexia women hospitalized in a specialized Eating Disorder Unit will participate to the study, randomized in 2 arms : Body image therapy with Anamorphic Micro software Body image therapy as usual

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
anorexia nervosa, CMME-TCA Unit, Centre Hospitalier Sainte Anne

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
Body image therapy with Anamorphic Micro software
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
Body image therapy as usual
Intervention Type
Behavioral
Intervention Name(s)
Anamorphic Micro software
Intervention Description
Body image therapy with Anamorphic Micro software
Intervention Type
Behavioral
Intervention Name(s)
therapy as usual
Intervention Description
Body image therapy as usual
Primary Outcome Measure Information:
Title
Body Shape Questionnaire
Description
Body Shape Questionnaire Score after the 10 sessions of body image therapy
Time Frame
after the 10 sessions of body image therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: woman more than 18 years old anorexia nervosa hospitalized in the CMME (CHSA) TCA Unit Body Mass Index ≥ 16 Informed consent Exclusion Criteria: pregnancy severe motor, sensitive or sensorial impairment no affiliation of national health service dependent of a trusteeship or guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra PHAM - SCOTTEZ, MD
Organizational Affiliation
Centre Hospitalier Sainte Anne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Sainte Anne
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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Body Image Therapy in Anorexia Nervosa

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