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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01437527
Other study ID # D465
Secondary ID 2010-A01427-32
Status Completed
Phase N/A
First received September 20, 2011
Last updated February 11, 2016
Start date December 2011
Est. completion date February 2016

Study information

Verified date February 2016
Source Centre Hospitalier St Anne
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of the study is to test a new procedure of body image therapy in anorexia nervosa, using the anamorphic micro software.


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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Anamorphic Micro software
Body image therapy with Anamorphic Micro software
therapy as usual
Body image therapy as usual

Locations

Country Name City State
France Centre Hospitalier Sainte Anne Paris

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Shape Questionnaire Body Shape Questionnaire Score after the 10 sessions of body image therapy after the 10 sessions of body image therapy No
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