Efficacy Study of an Olfactory Stimulation Program for the Recuperation of Autobiographical Memories in Anorexia (OLFANOR)
Primary Purpose
Anorexic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
olfactory stimulation program
Sponsored by
About this trial
This is an interventional supportive care trial for Anorexic focused on measuring anorexic, olfactory stimulation, autobiographical memories recovery
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
Sites / Locations
- Groupement des Hôpitaux de l'Institut Catholique de Lille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Program
Control
Arm Description
olfactory stimulation program
normal follow-up
Outcomes
Primary Outcome Measures
Proportion of reminded specific autobiographical memories (Autobiographical Memory Test (AMT)
Autobiographical Memory Test (AMT) at inclusion and 5 weeks after
Secondary Outcome Measures
Body mass index
Evaluation of size and weight
Evaluation of the specific memories recovery stimulation on the emotional differentiation ability (Level of Emotional Awareness Scale (LEAS)
Level of Emotional Awareness Scale (LEAS)
Evaluation of mental rumination (Cambridge Exeter Rumination Thinking Scale)
Cambridge Exeter Rumination Thinking Scale
Evaluation of anxiety and depression (Hospital Anxiety and Depression Scale)
Hospital Anxiety and Depression Scale
Evaluation of eating behaviors (Eating Disorder Inventory)
Eating Disorder Inventory
Evaluation of history of abuse (Childhood Trauma Questionnaire)
Childhood Trauma Questionnaire
Evaluation of cognitive avoidance strategies (Questionnaire of cognitive avoidance)
Questionnaire of cognitive avoidance
Full Information
NCT ID
NCT02297165
First Posted
November 4, 2014
Last Updated
August 20, 2018
Sponsor
Lille Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT02297165
Brief Title
Efficacy Study of an Olfactory Stimulation Program for the Recuperation of Autobiographical Memories in Anorexia
Acronym
OLFANOR
Official Title
Efficacy Study of an Olfactory Stimulation Program in Relaxing Environment for the Recuperation of Autobiographical Memories in Anorexic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexic
Keywords
anorexic, olfactory stimulation, autobiographical memories recovery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Program
Arm Type
Experimental
Arm Description
olfactory stimulation program
Arm Title
Control
Arm Type
No Intervention
Arm Description
normal follow-up
Intervention Type
Behavioral
Intervention Name(s)
olfactory stimulation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of reminded specific autobiographical memories (Autobiographical Memory Test (AMT)
Description
Autobiographical Memory Test (AMT) at inclusion and 5 weeks after
Time Frame
After 5 weeks
Secondary Outcome Measure Information:
Title
Body mass index
Description
Evaluation of size and weight
Time Frame
first day of enrollment and 5 weeks after
Title
Evaluation of the specific memories recovery stimulation on the emotional differentiation ability (Level of Emotional Awareness Scale (LEAS)
Description
Level of Emotional Awareness Scale (LEAS)
Time Frame
first day of enrollment and 5 weeks after
Title
Evaluation of mental rumination (Cambridge Exeter Rumination Thinking Scale)
Description
Cambridge Exeter Rumination Thinking Scale
Time Frame
first day of enrollment and 5 weeks after
Title
Evaluation of anxiety and depression (Hospital Anxiety and Depression Scale)
Description
Hospital Anxiety and Depression Scale
Time Frame
first day of enrollment and 5 weeks after
Title
Evaluation of eating behaviors (Eating Disorder Inventory)
Description
Eating Disorder Inventory
Time Frame
first day of enrollment and 5 weeks after
Title
Evaluation of history of abuse (Childhood Trauma Questionnaire)
Description
Childhood Trauma Questionnaire
Time Frame
first day of enrollment and 5 weeks after
Title
Evaluation of cognitive avoidance strategies (Questionnaire of cognitive avoidance)
Description
Questionnaire of cognitive avoidance
Time Frame
first day of enrollment and 5 weeks after
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Dodin
Organizational Affiliation
Groupement des Hôpitaux de l'Institut Catholique de Lille
Official's Role
Study Director
Facility Information:
Facility Name
Groupement des Hôpitaux de l'Institut Catholique de Lille
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy Study of an Olfactory Stimulation Program for the Recuperation of Autobiographical Memories in Anorexia
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