Trial record 3 of 47 for:    Open Studies | "Anorexia Nervosa"

Body Image Therapy in Anorexia Nervosa (PIPA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Centre Hospitalier St Anne.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier St Anne
ClinicalTrials.gov Identifier:
NCT01437527
First received: September 20, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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


Condition Intervention
Anorexia Nervosa
Behavioral: Anamorphic Micro software
Behavioral: therapy as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Body Image Therapy in Anorexia Nervosa

Further study details as provided by Centre Hospitalier St Anne:

Primary Outcome Measures:
  • Body Shape Questionnaire [ Time Frame: after the 10 sessions of body image therapy ] [ Designated as safety issue: No ]
    Body Shape Questionnaire Score after the 10 sessions of body image therapy


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional arm
Body image therapy with Anamorphic Micro software
Behavioral: Anamorphic Micro software
Body image therapy with Anamorphic Micro software
Active Comparator: control arm
Body image therapy as usual
Behavioral: therapy as usual
Body image therapy as usual

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437527

Contacts
Contact: Alexandra PHAM - SCOTTEZ, MD +33 145 65 89 18 a.pham@ch-sainte-anne.fr
Contact: Cecile KLOCHENDLER +33 1 45 65 77 28 c.klochendler@ch-sainte-anne.fr

Locations
France
Centre Hospitalier Sainte Anne Not yet recruiting
Paris, France, 75014
Contact: Alexandra PHAM - SCOTTEZ, MD    +33 145 65 89 18    a.pham@ch-sainte-anne.fr   
Principal Investigator: Alexandra PHAM - SCOTTEZ, MD         
Sponsors and Collaborators
Centre Hospitalier St Anne
Investigators
Principal Investigator: Alexandra PHAM - SCOTTEZ, MD Centre Hospitalier Sainte Anne
  More Information

No publications provided

Responsible Party: Centre Hospitalier St Anne
ClinicalTrials.gov Identifier: NCT01437527     History of Changes
Other Study ID Numbers: D465, 2010-A01427-32
Study First Received: September 20, 2011
Last Updated: September 20, 2011
Health Authority: France: Ministry of Health

Keywords provided by Centre Hospitalier St Anne:
anorexia nervosa
CMME-TCA Unit
Centre Hospitalier Sainte Anne

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Eating Disorders
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 20, 2014