NCT02297165

Brief Summary

The purpose of this study is to estimate the impact of an olfactive stimulation, in relaxing environment, on the access at the autobiographical memories in anorexic patients.

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 Jun 2014

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

June 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

November 4, 2014

Last Update Submit

April 17, 2026

Conditions

Anorexic

Keywords

anorexicolfactory stimulationautobiographical memories recovery

Outcome Measures

Primary Outcomes (1)

  • Proportion of reminded specific autobiographical memories (Autobiographical Memory Test (AMT)

    Autobiographical Memory Test (AMT) at inclusion and 5 weeks after

    After 5 weeks

Secondary Outcomes (7)

  • Body mass index

    first day of enrollment and 5 weeks after

  • Evaluation of the specific memories recovery stimulation on the emotional differentiation ability (Level of Emotional Awareness Scale (LEAS)

    first day of enrollment and 5 weeks after

  • Evaluation of mental rumination (Cambridge Exeter Rumination Thinking Scale)

    first day of enrollment and 5 weeks after

  • Evaluation of anxiety and depression (Hospital Anxiety and Depression Scale)

    first day of enrollment and 5 weeks after

  • Evaluation of eating behaviors (Eating Disorder Inventory)

    first day of enrollment and 5 weeks after

  • +2 more secondary outcomes

Study Arms (2)

Program

EXPERIMENTAL

olfactory stimulation program

Behavioral: olfactory stimulation program

Control

NO INTERVENTION

normal follow-up

Interventions

olfactory stimulation programBEHAVIORAL

8 individual sessions of olfactory stimulation at the rate of 2 sessions per week. 3 semi-directed interviews will be help (one at the beginning of the trial, the second 5 weeks later and the third at 6 month). For each session, patients have to smell two different odors (previously selected from a panel presented to the patient during first visits) and then they are invited to evoke memories and feelings related to each odor.

Program

Eligibility Criteria

Age13 Years - 24 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Eating disorders, anorexia (restrictive form or mixed) according to DSM IV-TR ( Diagnostic and Statistical Manual of Mental Disorders IV - Text Revision) criteria
  • Patient hospitalized in a department of one of the inquiring centers for a minimal duration of 5 weeks
  • French language ability
  • Coverage by the social insurance
  • Fully informed patient who consent to participate in the study

You may not qualify if:

  • Major mental associated disorders (psychotic disorders, bipolar disorder, major depression), neurological disorders or addiction to substances
  • Psychotropic treatment (with the exception of antidepressants, anxiolytics and sleeping drugs, if the treatment was started more than 30 days ago)
  • Any disorder susceptible to alter the reasoning capacities, discernment or judgment
  • Physically or psychologically unable to answer questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, France

Location

Related Publications (1)

  • Gandolphe MC, Nandrino JL, Hendrickx M, Willem C, Cottencin O, Gerardin P, Guardia D, Buttitta M, Zanini V, Dodin V. Specificity and wealth of autobiographical memories in restrictive and mixed anorexic patients. PLoS One. 2021 Sep 10;16(9):e0256959. doi: 10.1371/journal.pone.0256959. eCollection 2021.

    PMID: 34506532RESULT

MeSH Terms

Conditions

Anorexia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent Dodin

    Groupement des Hôpitaux de l'Institut Catholique de Lille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 21, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2017

Study Completion

July 1, 2018

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)