Psychiatric DisorderTCA-Covid19NCT05780242
Recrudescence of Eating Conduct Disorders and Covid-19
An observational study of Psychiatric Disorder and Eating Disorders in Adolescence, run by Fondation Lenval at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Psychiatric Disorder, Eating Disorders in Adolescence, COVID-19
- What is being tested?
- Self-questionnaire Eating Attitudes, Situational Anxiety and Trait Anxiety and Beck Depression Inventory (BDI) scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2022to Apr 2024
- Phase
- Observational
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Inability to comply with the instructions defined and exposed during inclusion. Refusal of participation by the patient or one of the legal guardians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychiatry and Anthropology Research Protocol : Recrudescence of Eating Conduct Disorders and Covid-19: a Qualitative Study for a Psychiatric and Anthropological Cross-view
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.
Read the 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:
- Being tested
- Self-questionnaire Eating Attitudes, Situational Anxiety and Trait Anxiety, Beck Depression Inventory (BDI) scale, • Post-traumatic Check List Scale
- Medical subject headings
- Mental Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaire Eating AttitudesBehavioural
self-diagnostic and quantitative questionnaire of 40 questions evaluating the behavior, severity and evolution of anorexia nervosa
Situational Anxiety and Trait AnxietyBehavioural
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
Beck Depression Inventory (BDI) scaleBehavioural
a diagnostic self-questionnaire allowing a quantitative estimation of the intensity of depressive symptoms in adults and adolescents
• Post-traumatic Check List ScaleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TCA | interviews based on a questionnaire established beforehand evoking the history of eating disorders and the experience of the participant Receives: Behavioral: Self-questionnaire Eating Attitudes; Behavioral: Situational Anxiety and Trait Anxiety; Behavioral: Beck Depression Inventory (BDI) scale; Behavioral: • Post-traumatic Check List Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at inclusion
Secondary outcomes (3)
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.
Measured: at inclusion
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.
Measured: at inclusion
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).
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start12 Jul 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise-Emilie DUMAS, MD, Principal investigator, Fondation Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780242
- Sponsor's protocol ID
- 22-HPNCL-06
- Acronym
- TCA-Covid19
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatry and Anthropology Research Protocol : Recrudescence of Eating Conduct Disorders and Covid-19: a Qualitative Study for a Psychiatric and Anthropological Cross-view
- ClinicalTrials.gov ID
- NCT05780242
- Acronym / sponsor ID
- TCA-Covid19 / 22-HPNCL-06
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 22 Mar 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCA | – | Behavioral: Self-questionnaire Eating Attitudes, Behavioral: Situational Anxiety and Trait Anxiety, Behavioral: Beck Depression Inventory (BDI) scale, Behavioral: • Post-traumatic Check List Scaleinterviews based on a questionnaire established beforehand evoking the history of eating disorders and the experience of the participant |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to comply with the instructions defined and exposed during inclusion. Refusal of participation by the patient or one of the legal guardians
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 |
|---|---|---|
| Self-questionnaire Eating Attitudesself-diagnostic and quantitative questionnaire of 40 questions evaluating the behavior, severity and evolution of anorexia nervosa | Behavioural | TCA |
| Situational Anxiety and Trait Anxietyassess 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 | Behavioural | TCA |
| Beck Depression Inventory (BDI) scalea diagnostic self-questionnaire allowing a quantitative estimation of the intensity of depressive symptoms in adults and adolescents | Behavioural | TCA |
| • Post-traumatic Check List Scalequestionnaire 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. | Behavioural | TCA |
Primary outcome
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
3 secondary outcomes
Situational Anxiety and Trait Anxiety Inventory (STAI-Y)
Time frame: at inclusion
Beck Depression Inventory (BDI) scale
Time frame: at inclusion
Post-traumatic Check List Scale (PCL-5)
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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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.
Louise-Emilie DUMAS, MD principal investigator
Fondation Lenval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Eating Disorders in Adolescence, run by Fondation Lenval 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 2 inclusion and 1 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 29 Jan 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?
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?
Self-questionnaire Eating Attitudes Test-40 (time frame: at inclusion). 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 29 Jan 2024.