- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05780242
Recrudescence of Eating Conduct Disorders and Covid-19 (TCA-Covid19)
Psychiatry and Anthropology Research Protocol : Recrudescence of Eating Conduct Disorders and Covid-19: a Qualitative Study for a Psychiatric and Anthropological Cross-view
Study Overview
Status
Detailed Description
This study will be offered to all patients treated within the SUPEA of HPNCL for TCA. The active queue of patients is collected using the HPNCL medical software. Patients and their parents will be contacted by telephone to inform them and suggest that they participate in this study.
The schools will be chosen from those attended by the patients on this list. They will also be contacted by telephone to inform them and suggest that they participate in this study.
Interviews in the presence of two members of the research team (child psychiatrists, psychologists, anthropologists, etc.) will be offered to all patients. These interviews will be face-to-face when possible, but can also be done remotely, by teleconsultation, depending on the preferences of the participants.
These interviews will be based on a questionnaire established beforehand evoking the history of eating disorders and the experience of the participant in the study and his entourage of the Covid-19 health crisis.
All information exchanged during these interviews will be made anonymous (data collected and processed as well as the results presented). They will be used exclusively in the context of the study and not communicated to the medical team involved in the patient's care.
The proposed interviews will be carried out separately with:
- The patient presenting or having presented a TCA
- The parents
- One or more health professionals taking care of the patient
- The school attended by the patient who will be questioned about the TCA and Covid-19 problem in general or not about the patient in particular.
Questionnaires will also be carried out with patients in order to complete the assessment of their clinical condition at a distance from the psychological crisis:
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nice, France
- Hôpital Lenval
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- The patient presenting or having presented a TCA
- The parents
- One or more health professionals taking care of the patient
- The school attended by the patient who will be questioned about the TCA and Covid-19 problem in general or not about the patient in particular.
Description
Inclusion Criteria:
Any patient having consulted in the child psychiatric emergency room of the HPNCL between November 1, 2021 and November 30, 2021 for suicidal thoughts.
Age between 13 years and 17 years and 11 months. Good understanding of written and oral French. Collection of the informed consent of the patient and of one of the two parents or holder of parental authority
Exclusion Criteria:
Inability to comply with the instructions defined and exposed during inclusion. Refusal of participation by the patient or one of the legal guardians
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
TCA
interviews based on a questionnaire established beforehand evoking the history of eating disorders and the experience of the participant
|
self-diagnostic and quantitative questionnaire of 40 questions evaluating the behavior, severity and evolution of anorexia nervosa
assess anxiety as a "personality trait" (feelings of apprehension, tension, nervousness and worry that the subject usually feels), and anxiety as a ' "emotional state" linked to a particular situation
a diagnostic self-questionnaire allowing a quantitative estimation of the intensity of depressive symptoms in adults and adolescents
questionnaire includes 20 items, each question is to be rated between 1 and 5 depending on the intensity and frequency of symptoms during the previous month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-questionnaire Eating Attitudes Test-40
Time Frame: at inclusion
|
It is a self-diagnostic and quantitative questionnaire of 40 questions evaluating the behavior, severity and evolution of anorexia nervosa.
The total score varies from 0 to 120.
The threshold score is 30 to define an eating disorder
|
at inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Situational Anxiety and Trait Anxiety Inventory (STAI-Y)
Time Frame: at inclusion
|
This inventory aims to assess anxiety as a "personality trait" (feelings of apprehension, tension, nervousness and worry that the subject usually feels), and anxiety as a ' "emotional state" linked to a particular situation (feelings of apprehension, tension or nervousness that the subject feels at a specific moment). This is a questionnaire comprising 20 items for the "state" form and 20 items for the "trait" form. The instruction is to answer "in general, in the usual way" for the "trait" scale and "at the moment" for the "state" scale. Each score can therefore vary from 20 to 80 with a "very high" anxiety norm when the threshold is > 65, "high" between 56 and 65, "medium" between 46 and 55, "low" between 36 and 45 and "very low" for a score < or = 35. |
at inclusion
|
|
Beck Depression Inventory (BDI) scale
Time Frame: at inclusion
|
The Beck Depression Inventory is a diagnostic self-questionnaire allowing a quantitative estimation of the intensity of depressive symptoms in adults and adolescents.
It consists of 21 symptom and attitude items, which describe a specific behavioral manifestation of depression, graded from zero to three by a series of four statements reflecting the degree of severity of the symptom.
The subject must indicate, among the propositions, the one that best describes how he has felt during the last seven days.
The total score varies between 0 (absence of depressive symptoms) and 63.
Some authors suggest that in a normal population, a total BDI score greater than 15 is an argument in favor of depression.
The results of this scale can also be categorized according to: normal score < 15; mild depression: 10 to 18; moderate depression: 19 to 29; severe depression > 30.
|
at inclusion
|
|
Post-traumatic Check List Scale (PCL-5)
Time Frame: at inclusion
|
The questionnaire includes 20 items, each question is to be rated between 1 and 5 depending on the intensity and frequency of symptoms during the previous month.
The maximum score is 80.
A threshold of 33 to 38 is proposed for screening for post-traumatic stress disorder (PTSD).
|
at inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Louise-Emilie DUMAS, MD, Fondation Lenval
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- COVID-19
- Problem Behavior
- Feeding and Eating Disorders
- Recurrence
- Mental Disorders
- Conduct Disorder
Other Study ID Numbers
- 22-HPNCL-06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
PfizerActive, not recruitingCOVID-19 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | COVID-19 Vaccines | SARS-CoV-2 Infection, COVID19 | COVID-19 Vaccination | SARS-CoV-2 Infection, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionUnited States
-
Shanghai Public Health Clinical CenterNot yet recruiting
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RecruitingPost COVID-19 Condition | Post COVID-19 | Post COVID-19 Syndrome | Long COVID-19 Syndrome | Post COVID-19 Condition (PCC)Germany
-
PfizerRecruitingRespiratory Tract Diseases | COVID-19 | Pneumonia | Lung Diseases | Coronavirus Disease 2019 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | Upper Respiratory Tract Infections | Respiratory Tract Infection | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionBelgium
-
ModeX Therapeutics, An OPKO Health CompanyRecruitingCOVID -19 | COVID-19 (Prevention)United States
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRecruitingFatigue | Post-COVID-19 Syndrome | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19 | Long-COVID | Post-COVID ConditionCanada
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
University of Missouri, Kansas CityNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruitingCOVID-19 Testing BehaviorsUnited States
Clinical Trials on Self-questionnaire Eating Attitudes
-
Penn State UniversityCompletedObesity, Childhood
-
Istanbul Arel UniversityIstanbul UniversityCompletedBody Image Disturbance | Eating DisordersTurkey
-
University of PadovaUniversity of Rome G. MarconiNot yet recruiting
-
Universidad de GranadaUniversidad Pública de NavarraCompletedObesity, Abdominal | Time Restricted Feeding | Cardiometabolic SyndromeSpain
-
Great Ormond Street Hospital for Children NHS Foundation...WithdrawnDisordered EatingUnited Kingdom
-
University of MinhoFundação para a Ciência e a TecnologiaRecruitingHealthy EatingPortugal
-
University of LouisvilleMeda PharmaceuticalsCompleted
-
Centre Hospitalier Universitaire DijonRecruitingType 2 Diabetes | Foot WoundFrance
-
Yale UniversityCompletedBinge-Eating Disorder | Overweight or Obesity | Binge EatingUnited States
-
TC Erciyes UniversityScientific and Technological Research Council of TurkeyNot yet recruiting