- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02538796
The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa.
The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa. A Monocentric Study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Saint-etienne, Frankrike, 42000
- CHU de Saint-Etienne
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria for patients:
- Restrictive anorexia nervosa according to Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM IV-TR)
- BMI> 16 to avoid the effects of undernutrition
- Start disorders <10 years
- Right handed
- Having given free and informed consent prior to study participation
- Subject affiliated to the French National Health Insurance
Inclusion Criteria for control group:
- BMI between 18,5 and 25
- Right handed
- Of school level paired in that of the patients (+/-1 the year)
- Having given free and informed consent prior to study participation
- Subject affiliated to the French National Health Insurance
Exclusion Criteria for patients and control group:
- Patients with at the beginning or during the study form of purgative anorexia nervosa
- Control with disorders of current or past eating behavior.
- Control making a restrictive diet during the study period
- Participants with depressive table
- Participants with a somatic problem restricted movement or a problem of uncorrected visual acuity annoying reading of the screen.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Patients group 1
TEA + Grober Test + Task 1 + Grober Test
|
The Test of Everyday Attention (TEA) measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 1 consists of a stimulus that moves on the screen. The response of the patient is done on the keyboard. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words. |
|
Eksperimentell: Patients group 2
TEA + Grober Test + Task 2 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 2 consists of a stimulus that is fixed on the screen. The response of the patient is done by pushing or pulling a lever. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words. |
|
Eksperimentell: Patients group 3
TEA + Grober Test + Implicit Task 3 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are implicit condition to detect an A in the word ("yes-no" answer). |
|
Eksperimentell: Patients group 4
TEA + Grober Test + Explicit Task 3 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are explicit condition to judge the emotional value of words ("positive-negative" answer). |
|
Aktiv komparator: Healthy volonteers group 1
TEA + Grober Test + Task 1 + Grober Test
|
The Test of Everyday Attention (TEA) measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 1 consists of a stimulus that moves on the screen. The response of the patient is done on the keyboard. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words. |
|
Aktiv komparator: Healthy volonteers group 2
TEA + Grober Test + Task 2 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 2 consists of a stimulus that is fixed on the screen. The response of the patient is done by pushing or pulling a lever. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words. |
|
Aktiv komparator: Healthy volonteers group 3
TEA + Grober Test + Implicit Task 3 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are implicit condition to detect an A in the word ("yes-no" answer). |
|
Aktiv komparator: Healthy volonteers group 4
TEA + Grober Test + Explicit Task 3 + Grober Test
|
The TEA measures the reaction time of the participant during the occurrence of an expected stimulus. The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term. The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are explicit condition to judge the emotional value of words ("positive-negative" answer). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Response time (ms) in the different conditions of the three tasks (composite measure)
Tidsramme: Day 1
|
Tasks are:
|
Day 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
BMI in kg/m²
Tidsramme: Day 1
|
The Body Mass Index (BMI) is defined as the body mass divided by the square of the body height.
|
Day 1
|
|
Rate of wrong answers
Tidsramme: Day 1
|
It is the rate of wrong answers in the different conditions of the three tasks.
|
Day 1
|
|
Score EDI-2
Tidsramme: Day 1
|
The Eating Disorder Inventory (EDI) is a self-report questionnaire used to assess the presence of eating disorders.
|
Day 1
|
|
Silhouettes test score
Tidsramme: Day 1
|
The patient selects among several silhouettes a silhouette to represent her real body image and her ideal body image.
|
Day 1
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Catherine MASSOUBRE, MD PhD, CHU de Saint-Etienne
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1001179
- 2010-A01523-36 (Annen identifikator: ANSM)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .