Clinical trial NCT02297165: Efficacy Study of an Olfactory Stimulation Program for the Recuperation of Autobiographical Memories in Anorexia
Official title: Efficacy Study of an Olfactory Stimulation Program in Relaxing Environment for the Recuperation of Autobiographical Memories in Anorexic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexic
Keywords: anorexic
olfactory stimulation
autobiographical memories recovery
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of reminded specific autobiographical memories (Autobiographical Memory Test (AMT)
timeFrame: After 5 weeks
Secondary outcomes:
measure: Body mass index
timeFrame: first day of enrollment and 5 weeks after
measure: Evaluation of the specific memories recovery stimulation on the emotional differentiation ability (Level of Emotional Awareness Scale (LEAS)
timeFrame: first day of enrollment and 5 weeks after
measure: Evaluation of mental rumination (Cambridge Exeter Rumination Thinking Scale)
timeFrame: first day of enrollment and 5 weeks after
measure: Evaluation of anxiety and depression (Hospital Anxiety and Depression Scale)
timeFrame: first day of enrollment and 5 weeks after
measure: Evaluation of eating behaviors (Eating Disorder Inventory)
timeFrame: first day of enrollment and 5 weeks after
measure: Evaluation of history of abuse (Childhood Trauma Questionnaire)
timeFrame: first day of enrollment and 5 weeks after
measure: Evaluation of cognitive avoidance strategies (Questionnaire of cognitive avoidance)
timeFrame: first day of enrollment and 5 weeks after
Other outcomes:
Locations:
city: Lille
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Vincent Dodin
role: STUDY_DIRECTOR
References: