Anorexia NervosaNCT02538796
The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa.
A study testing TEA + Grober Test + Task 1 + Grober Test, TEA + Grober Test + Task 2 + Grober Test and TEA + Grober Test + Implicit Task 3 + Grober Test in people with Anorexia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality) that has changed little over in half a century. One of the forms is the restrictive anorexia nervosa (ANR). It consists of a phobia of weight gain and food with a massive food restriction. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- TEA + Grober Test + Task 1 + Grober Test, TEA + Grober Test + Task 2 + Grober Test and TEA + Grober Test + Implicit Task 3 + Grober Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa. A Monocentric Study
Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality) that has changed little over in half a century. One of the forms is the restrictive anorexia nervosa (ANR). It consists of a phobia of weight gain and food with a massive food restriction. This pathology is studied in psychology but not using the theories of embodied cognition in which "perception and action" interact through sensorimotor processes. They are the source of attitudes (unconscious) towards certain stimuli and influence our interpretation (conscious).
Read the detailed description
The investigators hypothesis is that food restriction behavior is the result of two processes. One automatic and not conscious, which is an attraction toward food and manifests itself in the motivational attitudes of approach, and the other controlled and conscious, which prevents attraction to this type of stimuli and is manifested by motivational attitudes avoidance. These processes of attraction and avoidance are observed in embodied cognition paradigms because the answers induce movement of approach or avoidance of stimuli. The validation of these assumptions could lead to reconsideration of the respective roles of automatic and controlled processes in food behaviors of anorexics patients and to complete or refocus psychological techniques of care.
- Conditions
- Anorexia Nervosa
- Being tested
- TEA + Grober Test + Task 1 + Grober Test, TEA + Grober Test + Task 2 + Grober Test, TEA + Grober Test + Implicit Task 3 + Grober Test, TEA + Grober Test + Explicit Task 3 + Grober Test
- Keywords
- Anorexia Nervosa, Cognition, Conscious, Non-Conscious
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEA + Grober Test + Task 1 + Grober TestOther
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.
TEA + Grober Test + Task 2 + Grober TestOther
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.
TEA + Grober Test + Implicit Task 3 + Grober TestOther
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).
TEA + Grober Test + Explicit Task 3 + Grober TestOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients group 1 | Experimental | TEA + Grober Test + Task 1 + Grober Test Receives: Other: TEA + Grober Test + Task 1 + Grober Test |
| Patients group 2 | Experimental | TEA + Grober Test + Task 2 + Grober Test Receives: Other: TEA + Grober Test + Task 2 + Grober Test |
| Patients group 3 | Experimental | TEA + Grober Test + Implicit Task 3 + Grober Test Receives: Other: TEA + Grober Test + Implicit Task 3 + Grober Test |
| Patients group 4 | Experimental | TEA + Grober Test + Explicit Task 3 + Grober Test Receives: Other: TEA + Grober Test + Explicit Task 3 + Grober Test |
| Healthy volonteers group 1 | Active comparator | TEA + Grober Test + Task 1 + Grober Test Receives: Other: TEA + Grober Test + Task 1 + Grober Test |
| Healthy volonteers group 2 | Active comparator | TEA + Grober Test + Task 2 + Grober Test Receives: Other: TEA + Grober Test + Task 2 + Grober Test |
| Healthy volonteers group 3 | Active comparator | TEA + Grober Test + Implicit Task 3 + Grober Test Receives: Other: TEA + Grober Test + Implicit Task 3 + Grober Test |
| Healthy volonteers group 4 | Active comparator | TEA + Grober Test + Explicit Task 3 + Grober Test Receives: Other: TEA + Grober Test + Explicit Task 3 + Grober Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response time (ms) in the different conditions of the three tasks (composite measure)
Tasks are:
- tap a key on the computer keyboard during the presentation of food and non-food words containing an "A" on a computer screen
- pull a lever towards you at the presentation of food and non-food words on a computer screen
- pull a lever towards you at the presentation of food and non-food words that approach on a computer screen
Measured: Day 1
Secondary outcomes (4)
BMI in kg/m²
The Body Mass Index (BMI) is defined as the body mass divided by the square of the body height.
Measured: Day 1
Rate of wrong answers
It is the rate of wrong answers in the different conditions of the three tasks.
Measured: Day 1
Score EDI-2
The Eating Disorder Inventory (EDI) is a self-report questionnaire used to assess the presence of eating disorders.
Measured: Day 1
Silhouettes test score
The patient selects among several silhouettes a silhouette to represent her real body image and her ideal body image.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startMay 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine MASSOUBRE, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538796
- Sponsor's protocol ID
- 1001179
- Other IDs
- 2010-A01523-36
- Status last verified
- Mar 2016
- First submitted
- 31 Aug 2015
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa. A Monocentric Study
- ClinicalTrials.gov ID
- NCT02538796
- Acronym / sponsor ID
- 1001179
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Cognition, Conscious, Non-Conscious
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality) that has changed little over in half a century. One of the forms is the restrictive anorexia nervosa (ANR). It consists of a phobia of weight gain and food with a massive food restriction. This pathology is studied in psychology but not using the theories of embodied cognition in which "perception and action" interact through sensorimotor processes. They are the source of attitudes (unconscious) towards certain stimuli and influence our interpretation (conscious).
Detailed description
The investigators hypothesis is that food restriction behavior is the result of two processes. One automatic and not conscious, which is an attraction toward food and manifests itself in the motivational attitudes of approach, and the other controlled and conscious, which prevents attraction to this type of stimuli and is manifested by motivational attitudes avoidance. These processes of attraction and avoidance are observed in embodied cognition paradigms because the answers induce movement of approach or avoidance of stimuli. The validation of these assumptions could lead to reconsideration of the respective roles of automatic and controlled processes in food behaviors of anorexics patients and to complete or refocus psychological techniques of care.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Patients group 1 | Experimental | Other: TEA + Grober Test + Task 1 + Grober TestTEA + Grober Test + Task 1 + Grober Test |
| Patients group 2 | Experimental | Other: TEA + Grober Test + Task 2 + Grober TestTEA + Grober Test + Task 2 + Grober Test |
| Patients group 3 | Experimental | Other: TEA + Grober Test + Implicit Task 3 + Grober TestTEA + Grober Test + Implicit Task 3 + Grober Test |
| Patients group 4 | Experimental | Other: TEA + Grober Test + Explicit Task 3 + Grober TestTEA + Grober Test + Explicit Task 3 + Grober Test |
| Healthy volonteers group 1 | Active comparator | Other: TEA + Grober Test + Task 1 + Grober TestTEA + Grober Test + Task 1 + Grober Test |
| Healthy volonteers group 2 | Active comparator | Other: TEA + Grober Test + Task 2 + Grober TestTEA + Grober Test + Task 2 + Grober Test |
| Healthy volonteers group 3 | Active comparator | Other: TEA + Grober Test + Implicit Task 3 + Grober TestTEA + Grober Test + Implicit Task 3 + Grober Test |
| Healthy volonteers group 4 | Active comparator | Other: TEA + Grober Test + Explicit Task 3 + Grober TestTEA + Grober Test + Explicit Task 3 + Grober Test |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEA + Grober Test + Task 1 + Grober TestThe 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. | Other | Healthy volonteers group 1, Patients group 1 |
| TEA + Grober Test + Task 2 + Grober TestThe 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. | Other | Healthy volonteers group 2, Patients group 2 |
| TEA + Grober Test + Implicit Task 3 + Grober TestThe 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). | Other | Healthy volonteers group 3, Patients group 3 |
| TEA + Grober Test + Explicit Task 3 + Grober TestThe 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). | Other | Healthy volonteers group 4, Patients group 4 |
Primary outcome
Response time (ms) in the different conditions of the three tasks (composite measure)
Time frame: Day 1
Tasks are: * tap a key on the computer keyboard during the presentation of food and non-food words containing an "A" on a computer screen * pull a lever towards you at the presentation of food and non-food words on a computer screen * pull a lever towards you at the presentation of food and non-food words that approach on a computer screen
4 secondary outcomes
BMI in kg/m²
Time frame: Day 1
Rate of wrong answers
Time frame: Day 1
Score EDI-2
Time frame: Day 1
Silhouettes test score
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine MASSOUBRE, MD PhD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEA + Grober Test + Task 1 + Grober Test, TEA + Grober Test + Task 2 + Grober Test and TEA + Grober Test + Implicit Task 3 + Grober Test in people with Anorexia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time (ms) in the different conditions of the three tasks (composite measure) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.