Body Image Therapy in Anorexia Nervosa | NCT01437527

Studies
Body Image Therapy in Anorexia Nervosa

NCT01437527

Sponsor

Centre Hospitalier St Anne

Status

Completed

Last Update Posted

Feb 12, 2016Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Anorexia Nervosa

Interventions

Anamorphic Micro software
therapy as usual

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-A01427-32	Other Identifier	Afssaps

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Sep 20, 2011

First Submission Date that Met QC Criteria

Sep 20, 2011

First Posted Date

Sep 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2016

Last Update Posted Date

Feb 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional arm	Experimental	Body image therapy with Anamorphic Micro software	Behavioral: Anamorphic Micro software
control arm	Active Comparator	Body image therapy as usual	Behavioral: therapy as usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anamorphic Micro software	Behavioral	Body image therapy with Anamorphic Micro software	Interventional arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body Shape Questionnaire	Body Shape Questionnaire Score after the 10 sessions of body image therapy	after the 10 sessions of body image therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandra PHAM - SCOTTEZ, MD	Centre Hospitalier Sainte Anne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Sainte Anne		Paris		75014	France

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa

Ancestor Terms

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided