COVID-19 Clinical Trial
— TCA-Covid19Official title:
Psychiatry and Anthropology Research Protocol : Recrudescence of Eating Conduct Disorders and Covid-19: a Qualitative Study for a Psychiatric and Anthropological Cross-view
Verified date | March 2023 |
Source | Fondation Lenval |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This qualitative study, combining psychiatric and anthropological perspectives, focused on the development and/or worsening of patients' eating disorders since Covid-19, as well as the experiences and perceptions of those around them - such as their family, teachers or staff. School and nursing staff. This multi-site approach will provide a multidimensional perspective on the experience of individuals and those around them, as well as a triangulation of data. The hypotheses to explain the increase in Eating Disorders (EDs) will be addressed through semi-structured interviews offered to study participants.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Lenval | Nice |
Lead Sponsor | Collaborator |
---|---|
Fondation Lenval |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-questionnaire Eating Attitudes Test-40 | 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 | Situational Anxiety and Trait Anxiety Inventory (STAI-Y) | 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 | |
Secondary | Beck Depression Inventory (BDI) scale | 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 | |
Secondary | Post-traumatic Check List Scale (PCL-5) | 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 |
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