Efficacy Study of an Olfactory Stimulation Program for the Recuperation of Autobiographical Memories in Anorexia

NCT ID: NCT02297165

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anorexic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Program

olfactory stimulation program

Group Type EXPERIMENTAL

olfactory stimulation program

Intervention Type BEHAVIORAL

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.

Control

normal follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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olfactory stimulation program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

13 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Dodin

Role: STUDY_DIRECTOR

Groupement des Hôpitaux de l'Institut Catholique de Lille

Locations

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Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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RC-P0028

Identifier Type: -

Identifier Source: org_study_id

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