- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02297165
Efficacy Study of an Olfactory Stimulation Program for the Recuperation of Autobiographical Memories in Anorexia (OLFANOR)
Efficacy Study of an Olfactory Stimulation Program in Relaxing Environment for the Recuperation of Autobiographical Memories in Anorexic Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France
- Groupement des Hôpitaux de l'Institut Catholique de Lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Program
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. |
|
No Intervention: Control
normal follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of reminded specific autobiographical memories (Autobiographical Memory Test (AMT)
Time Frame: After 5 weeks
|
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
Time Frame: first day of enrollment and 5 weeks after
|
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)
Time Frame: first day of enrollment and 5 weeks after
|
Level of Emotional Awareness Scale (LEAS)
|
first day of enrollment and 5 weeks after
|
|
Evaluation of mental rumination (Cambridge Exeter Rumination Thinking Scale)
Time Frame: first day of enrollment and 5 weeks after
|
Cambridge Exeter Rumination Thinking Scale
|
first day of enrollment and 5 weeks after
|
|
Evaluation of anxiety and depression (Hospital Anxiety and Depression Scale)
Time Frame: first day of enrollment and 5 weeks after
|
Hospital Anxiety and Depression Scale
|
first day of enrollment and 5 weeks after
|
|
Evaluation of eating behaviors (Eating Disorder Inventory)
Time Frame: first day of enrollment and 5 weeks after
|
Eating Disorder Inventory
|
first day of enrollment and 5 weeks after
|
|
Evaluation of history of abuse (Childhood Trauma Questionnaire)
Time Frame: first day of enrollment and 5 weeks after
|
Childhood Trauma Questionnaire
|
first day of enrollment and 5 weeks after
|
|
Evaluation of cognitive avoidance strategies (Questionnaire of cognitive avoidance)
Time Frame: first day of enrollment and 5 weeks after
|
Questionnaire of cognitive avoidance
|
first day of enrollment and 5 weeks after
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Vincent Dodin, Groupement des Hôpitaux de l'Institut Catholique de Lille
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-P0028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexic
-
Hvidovre University HospitalUniversity of CopenhagenCompleted
-
Centre Hospitalier Universitaire, AmiensCompleted
Clinical Trials on olfactory stimulation program
-
Selcuk UniversityCompletedPreterm Labor | Cesarean Delivery Affecting FetusTurkey
-
Centre Hospitalier St AnneRecruitingDisorders of Consciousness Due to Severe Brain InjuryFrance
-
Yuan ShenShanghai Mental Health CenterNot yet recruitingMCI-AD, Early Stage Alzheimer's Disease
-
Selcuk UniversityRecruitingPreterm Birth | Nutrition | Breast Milk | Digestion | Smell StimulationTurkey
-
University Hospital, Basel, SwitzerlandRecruiting
-
University Hospital, ToulouseInstitut National de la Santé Et de la Recherche Médicale, FranceNot yet recruiting
-
Children's Hospital of Fudan UniversityCompleted
-
Ankara UniversityCompleted
-
Fundacion Miguel ServetHospital of NavarraCompletedFrailty | Healthy Aging | Cognitive Decline | Olfactory Dysfunction | Physical Performance Decline in Older AdultsSpain
-
Centre Hospitalier Universitaire de NiceCompleted