- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Saint-etienne, Frankreich, 42000
- CHU DE SAINT-ETIENNE
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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. |
Experimental: 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. |
Experimental: 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). |
Experimental: 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). |
Aktiver 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. |
Aktiver 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. |
Aktiver 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). |
Aktiver 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). |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Response time (ms) in the different conditions of the three tasks (composite measure)
Zeitfenster: Day 1
|
Tasks are:
|
Day 1
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
BMI in kg/m²
Zeitfenster: Day 1
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The Body Mass Index (BMI) is defined as the body mass divided by the square of the body height.
|
Day 1
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Rate of wrong answers
Zeitfenster: Day 1
|
It is the rate of wrong answers in the different conditions of the three tasks.
|
Day 1
|
Score EDI-2
Zeitfenster: Day 1
|
The Eating Disorder Inventory (EDI) is a self-report questionnaire used to assess the presence of eating disorders.
|
Day 1
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Silhouettes test score
Zeitfenster: Day 1
|
The patient selects among several silhouettes a silhouette to represent her real body image and her ideal body image.
|
Day 1
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Catherine MASSOUBRE, MD PhD, CHU DE SAINT-ETIENNE
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1001179
- 2010-A01523-36 (Andere Kennung: ANSM)
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