Psychiatric HealthStuCoTraNCT05070962
Complex Post-traumatic Stress Disorder: What Symptomatological Specificities
An observational study of Psychiatric Health, run by Raincy Montfermeil Hospital Group at 1 site in France.
Trial summary
A better understanding of the Complex Post-Traumatic Stress Disorder would allow a management as close as possible to the specificities of this one, but also a better training of professionals and adapted therapeutic indications. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Health
- What is being tested?
- clinical population
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2021to Feb 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The clinical population is made up of individuals who are victims of repeated trauma and are cared for in specialized centers; The general reference population is made up of volunteer students from the University of Lille.
Who may be able to join
- For clinical population;
- Age between 18 and 65 years old;
- Having experienced repeated and prolonged traumatic exposure;
- Able to understand and answer self-questionnaires;
- Having expressed their free and informed consent
- Affiliated with a social security scheme
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- For general population:
- Student volunteers from the University of Lille;
- Aged between 18 and 65 years old;
- Able to understand and answer self-questionnaires;
- Having expressed their free and informed consent.
Who cannot join
- For clinical population;
- People with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties);
- Persons under tutorship or curatorship;
- Persons deprived of their liberty.
- For general population:
- People with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties);
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- Persons under tutorship or curatorship;
- Persons deprived of their liberty;
- Persons having a link of subordination with the investigative team.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
USAP CHI Robert Ballanger Boulevard Robert Ballanger
Aulnay-sous-Bois, 93 600
Marion SIMION, oriane.simion.etu@univ-lille.fr
About this study
A better understanding of the Complex Post-Traumatic Stress Disorder would allow a management as close as possible to the specificities of this one, but also a better training of professionals and adapted therapeutic indications.
Read the detailed description
Post-Traumatic Stress Disorder manifests itself in a multitude of symptoms and self-regulation difficulties in various domains (somatization and biological balance, attention and consciousness, regulation of affects and impulses, interpersonal relationships and relational capacities, perception of the aggressor and of the aggression, self-perception and identity, sense and belief system) as well as profound changes in personality and various comorbidities .In addition, dissociation, the origin and the resulting disorders also have some similarities to Complex Post-Traumatic Stress Disorder. Indeed, dissociation is thought to have a traumatic origin and the symptomatology (eg hyperesthesia, dissociative amnesia, anesthesia) is included in Complex Post-Traumatic Stress Disorder. We can then ask ourselves the following questions: is Complex Post-Traumatic Stress Disorder a dissociative disorder in its own right causing difficulties with self-regulation? What is the share of dissociation in Complex Post-Traumatic Stress Disorder?
- Conditions
- Psychiatric Health
- Being tested
- clinical population
- Keywords
- Disorder,, complex post-traumatic stress disorder, personality disorders
- Medical subject headings
- Disease, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical populationOther
Also called general poupulation
or the general population, students of the University of Lille will be offered the opportunity to participate in a study through posters in the corridors of the faculties and announcements in the lecture halls.
| Study group | Role | What they receive |
|---|---|---|
| Clinical population | having experienced repeated and prolonged traumatic exposure Receives: Other: clinical population | |
| General population | Student volunteers from the University of Lille Receives: Other: clinical population |
What is being measured
The primary outcome is the main question the study is designed to answer.
the symptomatological characteristics of Complex Post-Traumatic Stress Disorder
to evaluate the symptomatic characteristics of TSPTc evoked by the authors (cognitions, emotional regulation, comorbidities, etc.) in order to better identify the symptomatic specificities of the disorder and improve its management.
Measured: during the study
Secondary outcomes (2)
Validation of the French version of two self-assessment scales;
Validate the French-language version of two TSPTc self-assessment scales (SIDES-SR and ITQ) on a French population;
Measured: during the study
differences in self-assessment of the participant's overall functioning and personality
differences in participant's general functioning and personality self-assessment between tCPD and personality disorders - specifically Borderline Personality Disorder (BPD).
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start17 Feb 2021
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric HealthStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raincy Montfermeil Hospital Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marion SIMION, Principal investigator, USAP CHI Robert Ballanger
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070962
- Sponsor's protocol ID
- GHT_ CHIRB -RIPH2_003
- Acronym
- StuCoTra
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 7 Oct 2021
- 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 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Post-traumatic Stress Disorder: What Symptomatological Specificities
- ClinicalTrials.gov ID
- NCT05070962
- Acronym / sponsor ID
- StuCoTra / GHT_ CHIRB -RIPH2_003
- Conditions
- Psychiatric Health
- Keywords
- Disorder,, complex post-traumatic stress disorder, personality disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Raincy Montfermeil Hospital GroupResearch network
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 7 Oct 2021 (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.
A better understanding of the Complex Post-Traumatic Stress Disorder would allow a management as close as possible to the specificities of this one, but also a better training of professionals and adapted therapeutic indications.
Detailed description
Post-Traumatic Stress Disorder manifests itself in a multitude of symptoms and self-regulation difficulties in various domains (somatization and biological balance, attention and consciousness, regulation of affects and impulses, interpersonal relationships and relational capacities, perception of the aggressor and of the aggression, self-perception and identity, sense and belief system) as well as profound changes in personality and various comorbidities .In addition, dissociation, the origin and the resulting disorders also have some similarities to Complex Post-Traumatic Stress Disorder. Indeed, dissociation is thought to have a traumatic origin and the symptomatology (eg hyperesthesia, dissociative amnesia, anesthesia) is included in Complex Post-Traumatic Stress Disorder. We can then ask ourselves the following questions: is Complex Post-Traumatic Stress Disorder a dissociative disorder in its own right causing difficulties with self-regulation? What is the share of dissociation in Complex Post-Traumatic Stress Disorder?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical population | – | Other: clinical populationhaving experienced repeated and prolonged traumatic exposure |
| General population | – | Other: clinical populationStudent volunteers from the University of Lille |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The clinical population is made up of individuals who are victims of repeated trauma and are cared for in specialized centers; The general reference population is made up of volunteer students from the University of Lille.
Key inclusion criteria (11 listed)
- For clinical population;
- Age between 18 and 65 years old;
- Having experienced repeated and prolonged traumatic exposure;
- Able to understand and answer self-questionnaires;
- Having expressed their free and informed consent
Key exclusion criteria (9 listed)
- For clinical population;
- People with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties);
- Persons under tutorship or curatorship;
- Persons deprived of their liberty.
- People with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties);
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 |
|---|---|---|
| clinical populationAlso: general poupulationor the general population, students of the University of Lille will be offered the opportunity to participate in a study through posters in the corridors of the faculties and announcements in the lecture halls. | Other | Clinical population, General population |
Primary outcome
the symptomatological characteristics of Complex Post-Traumatic Stress Disorder
Time frame: during the study
to evaluate the symptomatic characteristics of TSPTc evoked by the authors (cognitions, emotional regulation, comorbidities, etc.) in order to better identify the symptomatic specificities of the disorder and improve its management.
2 secondary outcomes
Validation of the French version of two self-assessment scales;
Time frame: during the study
differences in self-assessment of the participant's overall functioning and personality
Time frame: during the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- 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.
Marion SIMION principal investigator
USAP CHI Robert Ballanger
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 Health, run by Raincy Montfermeil Hospital Group 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 9 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 7 Oct 2021. 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 Marion SIMION (+ 33 6 76 25 00 26, oriane.simion.etu@univ-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the symptomatological characteristics of Complex Post-Traumatic Stress Disorder (time frame: during the study). 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 7 Oct 2021.