|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02297165 |
|
Date of registration:
|
04/11/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy Study of an Olfactory Stimulation Program for the Recuperation of Autobiographical Memories in Anorexia
OLFANOR |
|
Scientific title:
|
Efficacy Study of an Olfactory Stimulation Program in Relaxing Environment for the Recuperation of Autobiographical Memories in Anorexic Patients |
|
Date of first enrolment:
|
June 2014 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02297165 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Vincent Dodin |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Groupement des Hôpitaux de l'Institut Catholique de Lille |
| | |
|
Key inclusion & exclusion 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
Age minimum:
13 Years
Age maximum:
24 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Anorexic
|
|
Intervention(s)
|
|
Behavioral: olfactory stimulation program
|
|
Primary Outcome(s)
|
|
Proportion of reminded specific autobiographical memories (Autobiographical Memory Test (AMT)
[Time Frame: After 5 weeks]
|
|
Secondary Outcome(s)
|
|
Evaluation of eating behaviors (Eating Disorder Inventory)
[Time Frame: 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]
|
|
Evaluation of cognitive avoidance strategies (Questionnaire of cognitive avoidance)
[Time Frame: 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]
|
|
Body mass index
[Time Frame: 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]
|
|
Evaluation of anxiety and depression (Hospital Anxiety and Depression Scale)
[Time Frame: first day of enrollment and 5 weeks after]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|