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
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
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
NCT ID
NCT01437527
First Posted
September 20, 2011
Last Updated
February 11, 2016
Sponsor
Centre Hospitalier St Anne
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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