NCT03988218

Brief Summary

This study focuses on representations of the interior of the body and interoceptive awareness in women with anorexia nervosa in comparison with women without eating disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

June 13, 2019

Last Update Submit

July 19, 2021

Conditions

Keywords

Body awarenessInteroceptive awarenessAnorexia NervosaAdolescentBody image

Outcome Measures

Primary Outcomes (1)

  • drawing

    Number and nature of organs drawn

    At inclusion

Secondary Outcomes (2)

  • IAI

    At inclusion

  • Time

    At inclusion

Study Arms (2)

Anorexia

EXPERIMENTAL

Subjects with anorexia nervosa

Behavioral: perceptive tests

Control

ACTIVE COMPARATOR

Subjects without eating disorders

Behavioral: perceptive tests

Interventions

many tests are realized: a drawing of the interior of the body a heartbeat detection test an ischemia induction test many scales: Eating Attitude Test; Body Awareness Questionnaire; Body Shape Questionnaire; Hospital Anxiety and Depression; Questionnaire de Satisfaction Corporelle et de Perception Globale de Soi

Also known as: scales
AnorexiaControl

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Anorexia Nervosa according to DSM-5
  • aged above than 14
  • BMI between 14 and 18.5 for adults or less than the reference age by age for minors

You may not qualify if:

  • Unable to understand the tests, poor understanding of the French language
  • Mental retardation
  • Severe psychiatric comorbidity (bipolar disorder, schizophrenia)
  • Lesion or pathology of the upper limbs
  • Pregnancy
  • Absence of social protection
  • Hospitalization under duress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Esquirol

Limoges, 87000, France

Location

Related Publications (1)

  • Paquet A, Girard M, Passerieux C, Boule MC, Lacroix A, Sazerat P, Olliac B, Nubukpo P. The body interior in anorexia nervosa: from interoception to conceptual representation of body interior. Front Psychol. 2024 Jun 24;15:1389463. doi: 10.3389/fpsyg.2024.1389463. eCollection 2024.

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 17, 2019

Study Start

January 11, 2018

Primary Completion

March 25, 2019

Study Completion

July 7, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations