- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01437527
Body Image Therapy in Anorexia Nervosa (PIPA)
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75014
- Centre Hospitalier Sainte Anne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional arm
Body image therapy with Anamorphic Micro software
|
Body image therapy with Anamorphic Micro software
|
|
Active Comparator: control arm
Body image therapy as usual
|
Body image therapy as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Shape Questionnaire
Time Frame: after the 10 sessions of body image therapy
|
Body Shape Questionnaire Score after the 10 sessions of body image therapy
|
after the 10 sessions of body image therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandra PHAM - SCOTTEZ, MD, Centre Hospitalier Sainte Anne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D465
- 2010-A01427-32 (Other Identifier: Afssaps)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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