NCT01437527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

4.2 years

First QC Date

September 20, 2011

Last Update Submit

February 11, 2016

Conditions

Anorexia Nervosa

Keywords

anorexia nervosaCMME-TCA UnitCentre Hospitalier Sainte Anne

Outcome Measures

Primary Outcomes (1)

  • Body Shape Questionnaire

    Body Shape Questionnaire Score after the 10 sessions of body image therapy

    after the 10 sessions of body image therapy

Study Arms (2)

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

Anamorphic Micro softwareBEHAVIORAL

Body image therapy with Anamorphic Micro software

Interventional arm
therapy as usualBEHAVIORAL

Body image therapy as usual

control arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • woman
  • more than 18 years old
  • anorexia nervosa
  • hospitalized in the CMME (CHSA) TCA Unit
  • Body Mass Index ≥ 16
  • Informed consent

You may not qualify if:

  • pregnancy
  • severe motor, sensitive or sensorial impairment
  • no affiliation of national health service
  • dependent of a trusteeship or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte Anne

Paris, 75014, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Alexandra PHAM - SCOTTEZ, MD

    Centre Hospitalier Sainte Anne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 21, 2011

Study Start

December 1, 2011

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

FR(1)