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

Anorexic Clinical Trial

— OLFANOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297165
• Other study ID #: RC-P0028
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: July 2018

Study information

• Verified date: March 2017
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	Groupement des Hôpitaux de l'Institut Catholique de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of reminded specific autobiographical memories (Autobiographical Memory Test (AMT)	Autobiographical Memory Test (AMT) at inclusion and 5 weeks after	After 5 weeks
Secondary	Body mass index	Evaluation of size and weight	first day of enrollment and 5 weeks after
Secondary	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
Secondary	Evaluation of mental rumination (Cambridge Exeter Rumination Thinking Scale)	Cambridge Exeter Rumination Thinking Scale	first day of enrollment and 5 weeks after
Secondary	Evaluation of anxiety and depression (Hospital Anxiety and Depression Scale)	Hospital Anxiety and Depression Scale	first day of enrollment and 5 weeks after
Secondary	Evaluation of eating behaviors (Eating Disorder Inventory)	Eating Disorder Inventory	first day of enrollment and 5 weeks after
Secondary	Evaluation of history of abuse (Childhood Trauma Questionnaire)	Childhood Trauma Questionnaire	first day of enrollment and 5 weeks after
Secondary	Evaluation of cognitive avoidance strategies (Questionnaire of cognitive avoidance)	Questionnaire of cognitive avoidance	first day of enrollment and 5 weeks after