Anorexia NervosaSCAMNCT05682417
Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa
A study testing Body Map Assessment Tool: MOVE Tool, PAQ questionnaire and F-DFlex questionnaire in people with Anorexia Nervosa, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Anorexia nervosa is a predominantly female eating disorder that most often appears in adolescence. The latter leads to strict and voluntary food deprivation for several months or even years. The lifetime prevalence of anorexia is 1.4% in women and 0.2% in men. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Body Map Assessment Tool: MOVE Tool, PAQ questionnaire and F-DFlex questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to Sep 2026
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient over 15 years old
- Women
- Patient with a BMI <18.5
- Patient suffering from anorexia nervosa (DSM V, 2013)
- Patient agreeing to participate in the study with signed informed consent (Or whose parents/holder of parental authority have signed the informed consent)
- Patient affiliated to a Social Security plan or beneficiary of such a plan
Who cannot join
- Adult patients protected by a legal protection measure (guardianship, curatorship, etc.)
- Patients participating in another research that may interfere with this research
- Patients with acute and co-occurring psychiatric comorbidities (suicidal crisis, delusions)
- Patients not fluent in French
- Pregnant, parturient or breastfeeding women (on questioning of the patient)
- Persons deprived of their liberty by a judicial or administrative decision
- Persons admitted to a health or social establishment for purposes other than research
- Patients with any current pathology or history of psychotic disorders, migraine, epilepsy, balance disorders, vertigo, visual disorders, proprioceptive disorders and/or neuromuscular disorders.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Referral Center for Eating Disorders. Neurological Hospital-GH East / Hôpital Neurologique Pierre Wertheimer GHE HCL
Bron, 69500
Lisa FILIPPONE, Neuropsychologist, 0427856022 ext. +33, lisa.filippone@chu-lyon.fr
Lisa FILIPPONE, Neuropsychologist
About this study
Anorexia nervosa is a predominantly female eating disorder that most often appears in adolescence. The latter leads to strict and voluntary food deprivation for several months or even years. The lifetime prevalence of anorexia is 1.4% in women and 0.2% in men.
Ultimately, only half of people treated for anorexia nervosa in adolescence recover, 30% simply improve, 21% suffer from chronic disorders and 5 to 6% die. At the same time, between a quarter and half of patients abandon their current treatment, including during hospitalization. Relapses occur during the evolution of anorexia nervosa. Even more worrying, mortality is highest the year following the patient's discharge from hospital. This appears to be due to somatic complications in more than half of cases (most often cardiac arrest), to suicide in 27% of cases.
Read more
Researchers are still trying to clarify the mechanisms involved in the emergence and persistence of this disorder. The objective is to obtain more verified and faster cures. However, the obstacles to successful treatment are mainly due to the denial of disorders and thinness.
From a neurocognitive perspective, the representation one has of one's body is underpinned by two types of representations, i.e. body image and body schema.
It has long been shown that body image is altered in anorexia nervosa. More recently, authors have shown that the distortion of the body representation was however more extensive and also affected the body schema. Patients find themselves too fat despite obvious thinness and move through space as if this were really the case.
Worryingly, these distortions in bodyschema seem to persist after therapeutic management. Despite the potential role of body-scheme distortions in maintaining the disorder, as well as the risk of relapse, the difficulties in assessing body-scheme are significant. Indeed, recovery in these pathologies is often determined according to the Body Mass Index, self-declaration and questionnaires evaluating body image, again limiting the verification of the resorption of distortions in the body schema.
Investigators have therefore developed the systematic, ergonomic and simplified evaluation of the body schema in patients suffering from anorexia nervosa at the time of diagnosis in an expert center, but also during follow-up evaluations thanks to the use of an evaluation platform of the body schema, i.e. the body in brain platform, developed by the LIP/PC2S laboratory and the SATT Linksium which allows the evaluation of the body schema.
- Conditions
- Anorexia Nervosa
- Being tested
- Body Map Assessment Tool: MOVE Tool, PAQ questionnaire, F-DFlex questionnaire, BSQ questionnaire, Silhouette testing
- Keywords
- Anorexia nervosa, Body image, Body distortion
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Map Assessment Tool: MOVE ToolDevice
In VR, a spherical object approaches with linear trajectory the body of patients, it can be sent to 4 parts of the body (mid-arm/waist/hip/mid-thigh) both left and right side. Several conditions are presented, either the trajectory leads the object to touch the body, or it passes at ≠ distances from it. Patient is instructed to move only if he thinks the object will touch his body.
Procedure begins with a measurement taken on 3 body locations via the Move tool (shoulders/hips/thighs) to create an avatar allowing the tool to determine whether or not movement was necessary. Then, the movement of the patient is recorded. For each object/body distance, the software determines if dodging was necessary. The overestimation of the body schema corresponds to the average distance from which the patient considers that the object would have touched her body and performs a dodging movement, compared to her real morphological dimensions. This generates a body limit distortion % for each body area.
PAQ questionnaireOther
This questionnaire has been translated and validated (French version, Luminet et al., 2021). This is a self-reported measure of alexithymia in 24 items. It is designed to measure all the components of alexithymia for both negative and positive emotions. Five subscale scores and six composite scores can be obtained from the questionnaire, with high scores indicating higher levels of alexithymia.
F-DFlex questionnaireOther
This questionnaire (Detail and Flexibility Questionnaire, French version of Maria et al, 2020) assesses cognitive rigidity. This questionnaire assesses two frequently impaired cognitive dimensions in people with anorexia nervosa, central coherence and cognitive flexibility in daily functioning using 20 self-completed items.
BSQ questionnaireOther
The Body Shape Questionnaire (BSQ, translated and validated in French by Rousseau et al., 2005) is a one-dimensional Anglo-Saxon self-questionnaire of 34 items that assesses concerns about body shape over the past four weeks. Responses are scored on a 6-point Likert scale. A score of 1 ("never") means the problem is not present, up to a score of 6 ("always") which means the problem is always present. The higher the score, the more the concern/dissatisfaction with one's body tends to be pathological.
Silhouette testingOther
Body overestimation is assessed by the computerized silhouette test (adapted from Gardner \& Brown, 2010, Van der Linder et al., 2017). Twenty-seven Body Mass Index silhouettes ranging from 11 to 40 are presented to participants in random order. For each silhouette presented, the participant answers whether or not the silhouette presented corresponds to her current silhouette. A body underestimation index is calculated as follows: Estimated figure average BMI - actual BMI.
Eating Disorder Inventory - 2Other
Allows self-assessment of symptoms of eating disorders. It is composed of 91 questions grouped into 11 subscales that assess specific cognitive and behavioral dimensions: desire for thinness, bulimia, body dissatisfaction, feeling of inefficiency, perfectionism, interpersonal distrust, interoceptive sensitivity, fears relating to maturity, asceticism. , impulsiveness and social insecurity. For each item, participants can answer "always", "usually", "often", "sometimes", "rarely" or "never". The score for each item is between 0 and 3. The subscale scores are calculated by simply adding all the item scores for each specific subscale. This questionnaire has demonstrated good internal consistency, test-retest reliability, and validity (Garner, 1991)
EDEQ questionnaireOther
Or "Eating Disorders Examination - Questionnaire" (Fairburn \& Beglin, 2008). This questionnaire assesses eating behaviors and concerns about weight and body shape, using 28 items focusing on these aspects over the past 28 days.
STAI questionnaireOther
The Spielberger Anxiety Scale (STAI) State and Trait. This questionnaire includes two distinct scales: one evaluating the current state of anxiety (STAI form Y-A: feelings of apprehension, tension, nervousness and worry that the subject feels at a precise precise moment) and the second evaluating the anxious personality trait (STAI form Y-B: feelings of apprehension, tension, nervousness, and worry that the subject usually feels). The Y version was developed in order to eliminate the items having appeal to depression compared to the initial form. Each scale has 20 items. This questionnaire has good psychometric qualities regarding validity, reproducibility and inter-individual sensitivity. It correlates well with other anxiety questionnaires in a literature review of anxiety questionnaires (Elwood, 2012).
BECK questionnaireOther
Beck Depression Inventory (Beck, 1987). The inventory is composed of items related to depressive symptoms as well as physical symptoms. This is a questionnaire that gives a quantitative estimate of the intensity of depression. Investigators will use the abbreviated version consisting of 13 items, each item comprising 4 sentences corresponding to 4 degrees of increasing intensity of a symptom on a scale of 0 to 3. The total score corresponds to the sum of the different items and makes it possible to judge the presence of depression and its intensity.
| Study group | Role | What they receive |
|---|---|---|
| Patients with anorexia nervosa according to DSM-5 | Experimental | Patients over 15 years old, suffering from anorexia nervosa according to DSM-V with a BMI<18.5 and without psychiatric comorbidities Receives: Device: Body Map Assessment Tool: MOVE Tool; Other: PAQ questionnaire; Other: F-DFlex questionnaire; Other: BSQ questionnaire; Other: Silhouette testing; Other: Eating Disorder Inventory - 2; Other: EDEQ questionnaire; Other: STAI questionnaire; Other: BECK questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overestimation of the body schema
Overestimation of the body schema (in percentage) assessed by the body schema assessment platform (MOVE tool, motion assessment in virtual reality).
Overestimation of the body schema (percentage of distortion) will be compared to normal values, and then compared with the percentages at T+6 and T+12.
Measured: Baseline (T0); 6 months after baseline (T+6); 12 months after baseline (T+12)
Secondary outcomes (9)
Weight/height ratio, expressed by body mass index (BMI)
This weight(kg)/height(m)2 ratio is measured using a mathematical formula. It will be analyzed using the DSM-V reference table to measure the severity of the disorder.
Lightweight: BMI > or = 17 kg/m2 Moderate: BMI 16-16.99 kg/m2 Severe: BMI: 15-15.99 kg/m2 Extreme: BMI < 17 kg/m2
Measured: Baseline T0; 6 months; 12 months
Body overstatement
Body overestimation is assessed using the computerized silhouette test. This test presents 27 figures with BMIs ranging from 11 to 40. The patient answers whether or not the figure presented corresponds to his current figure.
Measured: Baseline T0; 6 months; 12 months
Alexithymia score
Alexithymia is assessed with the PAQ questionnaire consisting of 24 questions with 7 degrees of response. (1 strongly disagree - 2 - 3 - 4 Neither agree nor disagree -5 - 6 - 7 strongly agree)
Measured: Baseline T0; 6 months; 12 months
Cognitive rigidity score
The cognitive rigidity score is measured with the D-Flex questionnaire comprising 20 questions. The patient must then respond to the proposed statements using a 6-point scale (Strongly disagree (1), Somewhat disagree (2), Somewhat disagree (3), Somewhat agree (4) , Somewhat agree (5, Strongly agree (6).
Measured: Baseline T0; 6 months; 12 months
Body dissatisfaction score
Body dissatisfaction is measured with the BSQ questionnaire comprising 34 questions rated from 1 (never) to 6 (Always)
Measured: Baseline T0; 6 months; 12 months
Eating behavior assessed by the EDI-2 questionnaire
The eating behavior will be assessed by the EDI-2 questionnaire
Measured: Baseline T0; 6 months; 12 months
Eating behavior assessed by the EDE-Q questionnaire
The eating behavior will be assessed by the EDE-Q
Measured: Baseline T0; 6 months; 12 months
Level of anxiety
Anxiety is measured by STAI questionnaire.
Measured: Baseline T0; 6 months; 12 months
Level of Depression
Depression is measured by BECK questionnaire
Measured: Baseline T0; 6 months; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study startSep 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682417
- Sponsor's protocol ID
- 69HCL21_1364
- Acronym
- SCAM
- Status last verified
- Jun 2024
- First submitted
- 4 Jan 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05682417
- Acronym / sponsor ID
- SCAM / 69HCL21_1364
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Body image, Body distortion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Jan 2023 (actual)
- 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 is a predominantly female eating disorder that most often appears in adolescence. The latter leads to strict and voluntary food deprivation for several months or even years. The lifetime prevalence of anorexia is 1.4% in women and 0.2% in men.
Ultimately, only half of people treated for anorexia nervosa in adolescence recover, 30% simply improve, 21% suffer from chronic disorders and 5 to 6% die. At the same time, between a quarter and half of patients abandon their current treatment, including during hospitalization. Relapses occur during the evolution of anorexia nervosa. Even more worrying, mortality is highest the year following the patient's discharge from hospital. This appears to be due to somatic complications in more than half of cases (most often cardiac arrest), to suicide in 27% of cases.
Researchers are still trying to clarify the mechanisms involved in the emergence and persistence of this disorder. The objective is to obtain more verified and faster cures. However, the obstacles to successful treatment are mainly due to the denial of disorders and thinness.
From a neurocognitive perspective, the representation one has of one's body is underpinned by two types of representations, i.e. body image and body schema.
It has long been shown that body image is altered in anorexia nervosa. More recently, authors have shown that the distortion of the body representation was however more extensive and also affected the body schema. Patients find themselves too fat despite obvious thinness and move through space as if this were really the case.
Worryingly, these distortions in bodyschema seem to persist after therapeutic management. Despite the potential role of body-scheme distortions in maintaining the disorder, as well as the risk of relapse, the difficulties in assessing body-scheme are significant. Indeed, recovery in these pathologies is often determined according to the Body Mass Index, self-declaration and questionnaires evaluating body image, again limiting the verification of the resorption of distortions in the body schema.
Investigators have therefore developed the systematic, ergonomic and simplified evaluation of the body schema in patients suffering from anorexia nervosa at the time of diagnosis in an expert center, but also during follow-up evaluations thanks to the use of an evaluation platform of the body schema, i.e. the body in brain platform, developed by the LIP/PC2S laboratory and the SATT Linksium which allows the evaluation of the body schema.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with anorexia nervosa according to DSM-5 | Experimental | Device: Body Map Assessment Tool: MOVE Tool, Other: PAQ questionnaire, Other: F-DFlex questionnaire, Other: BSQ questionnaire, Other: Silhouette testing, Other: Eating Disorder Inventory - 2, Other: EDEQ questionnaire, Other: STAI questionnaire, Other: BECK questionnairePatients over 15 years old, suffering from anorexia nervosa according to DSM-V with a BMI<18.5 and without psychiatric comorbidities |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patient over 15 years old
- Women
- Patient with a BMI <18.5
- Patient suffering from anorexia nervosa (DSM V, 2013)
- Patient agreeing to participate in the study with signed informed consent (Or whose parents/holder of parental authority have signed the informed consent)
Key exclusion criteria (8 listed)
- Adult patients protected by a legal protection measure (guardianship, curatorship, etc.)
- Patients participating in another research that may interfere with this research
- Patients with acute and co-occurring psychiatric comorbidities (suicidal crisis, delusions)
- Patients not fluent in French
- Pregnant, parturient or breastfeeding women (on questioning of the patient)
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 |
|---|---|---|
| Body Map Assessment Tool: MOVE ToolIn VR, a spherical object approaches with linear trajectory the body of patients, it can be sent to 4 parts of the body (mid-arm/waist/hip/mid-thigh) both left and right side. Several conditions are presented, either the trajectory leads the object to touch the body, or it passes at ≠ distances from it. Patient is instructed to move only if he thinks the object will touch his body. Procedure begins with a measurement taken on 3 body locations via the Move tool (shoulders/hips/thighs) to create an avatar allowing the tool to determine whether or not movement was necessary. Then, the movement of the patient is recorded. For each object/body distance, the software determines if dodging was necessary. The overestimation of the body schema corresponds to the average distance from which the patient considers that the object would have touched her body and performs a dodging movement, compared to her real morphological dimensions. This generates a body limit distortion % for each body area. | Device | Patients with anorexia nervosa according to DSM-5 |
| PAQ questionnaireThis questionnaire has been translated and validated (French version, Luminet et al., 2021). This is a self-reported measure of alexithymia in 24 items. It is designed to measure all the components of alexithymia for both negative and positive emotions. Five subscale scores and six composite scores can be obtained from the questionnaire, with high scores indicating higher levels of alexithymia. | Other | Patients with anorexia nervosa according to DSM-5 |
| F-DFlex questionnaireThis questionnaire (Detail and Flexibility Questionnaire, French version of Maria et al, 2020) assesses cognitive rigidity. This questionnaire assesses two frequently impaired cognitive dimensions in people with anorexia nervosa, central coherence and cognitive flexibility in daily functioning using 20 self-completed items. | Other | Patients with anorexia nervosa according to DSM-5 |
| BSQ questionnaireThe Body Shape Questionnaire (BSQ, translated and validated in French by Rousseau et al., 2005) is a one-dimensional Anglo-Saxon self-questionnaire of 34 items that assesses concerns about body shape over the past four weeks. Responses are scored on a 6-point Likert scale. A score of 1 ("never") means the problem is not present, up to a score of 6 ("always") which means the problem is always present. The higher the score, the more the concern/dissatisfaction with one's body tends to be pathological. | Other | Patients with anorexia nervosa according to DSM-5 |
| Silhouette testingBody overestimation is assessed by the computerized silhouette test (adapted from Gardner \& Brown, 2010, Van der Linder et al., 2017). Twenty-seven Body Mass Index silhouettes ranging from 11 to 40 are presented to participants in random order. For each silhouette presented, the participant answers whether or not the silhouette presented corresponds to her current silhouette. A body underestimation index is calculated as follows: Estimated figure average BMI - actual BMI. | Other | Patients with anorexia nervosa according to DSM-5 |
| Eating Disorder Inventory - 2Allows self-assessment of symptoms of eating disorders. It is composed of 91 questions grouped into 11 subscales that assess specific cognitive and behavioral dimensions: desire for thinness, bulimia, body dissatisfaction, feeling of inefficiency, perfectionism, interpersonal distrust, interoceptive sensitivity, fears relating to maturity, asceticism. , impulsiveness and social insecurity. For each item, participants can answer "always", "usually", "often", "sometimes", "rarely" or "never". The score for each item is between 0 and 3. The subscale scores are calculated by simply adding all the item scores for each specific subscale. This questionnaire has demonstrated good internal consistency, test-retest reliability, and validity (Garner, 1991) | Other | Patients with anorexia nervosa according to DSM-5 |
| EDEQ questionnaireOr "Eating Disorders Examination - Questionnaire" (Fairburn \& Beglin, 2008). This questionnaire assesses eating behaviors and concerns about weight and body shape, using 28 items focusing on these aspects over the past 28 days. | Other | Patients with anorexia nervosa according to DSM-5 |
| STAI questionnaireThe Spielberger Anxiety Scale (STAI) State and Trait. This questionnaire includes two distinct scales: one evaluating the current state of anxiety (STAI form Y-A: feelings of apprehension, tension, nervousness and worry that the subject feels at a precise precise moment) and the second evaluating the anxious personality trait (STAI form Y-B: feelings of apprehension, tension, nervousness, and worry that the subject usually feels). The Y version was developed in order to eliminate the items having appeal to depression compared to the initial form. Each scale has 20 items. This questionnaire has good psychometric qualities regarding validity, reproducibility and inter-individual sensitivity. It correlates well with other anxiety questionnaires in a literature review of anxiety questionnaires (Elwood, 2012). | Other | Patients with anorexia nervosa according to DSM-5 |
| BECK questionnaireBeck Depression Inventory (Beck, 1987). The inventory is composed of items related to depressive symptoms as well as physical symptoms. This is a questionnaire that gives a quantitative estimate of the intensity of depression. Investigators will use the abbreviated version consisting of 13 items, each item comprising 4 sentences corresponding to 4 degrees of increasing intensity of a symptom on a scale of 0 to 3. The total score corresponds to the sum of the different items and makes it possible to judge the presence of depression and its intensity. | Other | Patients with anorexia nervosa according to DSM-5 |
Primary outcome
Overestimation of the body schema
Time frame: Baseline (T0); 6 months after baseline (T+6); 12 months after baseline (T+12)
Overestimation of the body schema (in percentage) assessed by the body schema assessment platform (MOVE tool, motion assessment in virtual reality). Overestimation of the body schema (percentage of distortion) will be compared to normal values, and then compared with the percentages at T+6 and T+12.
9 secondary outcomes
Weight/height ratio, expressed by body mass index (BMI)
Time frame: Baseline T0; 6 months; 12 months
Body overstatement
Time frame: Baseline T0; 6 months; 12 months
Alexithymia score
Time frame: Baseline T0; 6 months; 12 months
Cognitive rigidity score
Time frame: Baseline T0; 6 months; 12 months
Body dissatisfaction score
Time frame: Baseline T0; 6 months; 12 months
Eating behavior assessed by the EDI-2 questionnaire
Time frame: Baseline T0; 6 months; 12 months
Eating behavior assessed by the EDE-Q questionnaire
Time frame: Baseline T0; 6 months; 12 months
Level of anxiety
Time frame: Baseline T0; 6 months; 12 months
Level of Depression
Time frame: Baseline T0; 6 months; 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Map Assessment Tool: MOVE Tool, PAQ questionnaire and F-DFlex questionnaire in people with Anorexia Nervosa, run by Hospices Civils de Lyon 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa FILIPPONE, Neuropsychologist (0427856022 ext. +33, lisa.filippone@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overestimation of the body schema (time frame: Baseline (T0); 6 months after baseline (T+6); 12 months after baseline (T+12)). 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 4 Jun 2024.