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

Study Overview
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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.

Official Title
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Efficacy Study of an Olfactory Stimulation Program in Relaxing Environment for the Recuperation of Autobiographical Memories in Anorexic Patients

Conditions
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Anorexic

Intervention / Treatment
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* Behavioral: olfactory stimulation program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Program<br>olfactory stimulation program | Behavioral: olfactory stimulation program<br>* 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.<br>|
| No Intervention: Control<br>normal follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of reminded specific autobiographical memories (Autobiographical Memory Test (AMT) | Autobiographical Memory Test (AMT) at inclusion and 5 weeks after | After 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | Evaluation of size and weight | 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) | Level of Emotional Awareness Scale (LEAS) | first day of enrollment and 5 weeks after | 
| Evaluation of mental rumination (Cambridge Exeter Rumination Thinking Scale) | Cambridge Exeter Rumination Thinking Scale | first day of enrollment and 5 weeks after | 
| Evaluation of anxiety and depression (Hospital Anxiety and Depression Scale) | Hospital Anxiety and Depression Scale | first day of enrollment and 5 weeks after | 
| Evaluation of eating behaviors (Eating Disorder Inventory) | Eating Disorder Inventory | first day of enrollment and 5 weeks after | 
| Evaluation of history of abuse (Childhood Trauma Questionnaire) | Childhood Trauma Questionnaire | first day of enrollment and 5 weeks after | 
| Evaluation of cognitive avoidance strategies (Questionnaire of cognitive avoidance) | Questionnaire of cognitive avoidance | first day of enrollment and 5 weeks after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorexic, olfactory stimulation, autobiographical memories recovery