TraumaIRTIPAPNCT06432400
Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders
A study testing Patient questionnaires in people with Trauma, run by Hôpital NOVO at 2 sites in France.
Trial summary
The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Patient questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2024to Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 or over
- Patient followed up at the adult Medical and Psychological Centre in the centres taking part in the study
- Patient suffering from disorders related to the use of alcohol, cannabis, opiates, inhalants, sedatives, hypnotics, anxiolytics, stimulants, hallucinogens (all of these disorders will have been diagnosed by a doctor before or during follow-up according to DSM 5 criteria).
- Patient aware of their substance use disorders
- Patient informed and did not object to participating in the study
Who cannot join
- Patient previously diagnosed with PTSD or CPTSD
- Patient agitated and/or aggressive
- Patient under guardianship/curators
- Patient who do not speak or understand French
Trial locations and contacts
2 sites in 1 country.
France2 sites
Medical and Psychological Centre - Novo Hospital - Site Beaumont-sur-Oise
Beaumont-sur-Oise, 95260
Medical and Psychological Centre - Isarien Hospital Centre
Clermont, 60600
About this study
Official title: Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders Followed up in the Medical and Psychological Centre: Multicentre Descriptive Study
The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery.
Read the detailed description
Between 61% and 81% of men and 51% to 74% of women are exposed to a traumatic event in their lifetime. These events may be brief and discrete, prolonged and/or recurrent, and may be direct or indirect. Direct or indirect exposure to traumatic events can lead to serious negative psychological consequences, including post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD). People exposed to complex traumatic events are at risk not only of suffering from PTSD or Complex PTSD, but also from other mental health co-morbidities, such as substance use disorders (drugs, alcohol, benzodiazepine misuse) , often associated with the repetition of situations of interpersonal violence from which it is difficult, if not impossible, to escape.
Caring for people suffering from psychological trauma is a major public health issue. However, there are no good clinical practice guidelines for diagnosis, assessment and treatment, which would enable good practice to be standardised and disseminated. The prevention, detection, early support and appropriate guidance of people suffering from post-traumatic sequelae promote their recovery and improve their quality of life. The World Health Organization (WHO) refers to this as psychological distress, and points out that if it is not properly identified or accompanied, it can tip a person into illness or increase social difficulties. When it is temporary and follows a stressful event, it is considered a normal adaptive reaction. On the other hand, when it becomes intense and persistent, it may be an indicator of a psychological disorder. The public health challenge associated with PTSD is to better recognise, diagnose and treat it, as it can have serious consequences for the quality of life, social functioning and suicide risk of those affected.
The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery. It would also make it possible to provide individualised support for patients and improve their quality of life.
- Conditions
- Trauma
- Being tested
- Patient questionnaires
- Keywords
- Post Traumatic Stress Disorder, Complex post traumatic stress disorder, Medical and Psychological Centre
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient questionnairesOther
Patients questionnaires, on paper and data collection on patients medical file
| Study group | Role | What they receive |
|---|---|---|
| Substance use disorders | Other | Group composed of patients suffering from disorders related to the use of alcohol, cannabis, opiates, inhalants, sedatives, hypnotics, anxiolytics, stimulants, hallucinogens (all of these disorders will have been diagnosed by a doctor before or during follow-up according to Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM 5) criteria) Receives: Other: Patient questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the proportion of Post-Traumatic Stress Disorder (PTSD) in patients with substance use disorders
Percentage of patients with PTSD among those with substance use disorders Patients with PTSD will be identified using the International Trauma Questionnaire (ITQ) : A diagnosis of PTSD requires the presence of at least one symptom in each of the following dimensions
- P1 or P2 ≥ 2
- P3 or P4 ≥ 2
- 5 or P6 ≥ 2 AND
- P7 or P8 or P9 ≥ 2
Score ITQ for PTSD : ≥ 8
Measured: At the end of the study, an average of 12 month
Secondary outcomes (4)
Distinguishing between the prevalence of Post-Traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD)
Percentage of patients with CPTSD among those with substance use disorders Patients with CPTSD will be identified using the International Trauma Questionnaire (ITQ) : A diagnosis of CPTSD requires a PTSD : ≥ 8 and, at least, one symptom in each of the dimensions of disturbance of self-organisation
- C1 or C2 ≥ 2
- C3 or C4 ≥ 2
- C5 or C6 ≥ 2 AND
- C7 or C8 or C9 ≥ 2
Score ITQ for CPTSD : ≥ 16
Measured: At the end of the study, an average of 12 month
Identification of risk factors by comparing demographic data of PTSD versus CPTSD patients
Risk factors will be identified from the demographic data collected via the patient characteristics questionnaire between PTSD and CPTSD patients
Measured: At the end of the study, an average of 12 month
Identification of the pathologies most associated with PTSD and CPTSD
The pathologies most frequently associated with PTSD and CPTSD will be identified by collecting the pathologies present in the medical records of all patients.
Measured: At the end of the study, an average of 12 month
Comparison of the time between management and identification of patients with PTSD versus CPTSD
Comparison for number of days between the start of treatment for substance use disorders and the identification of PTSD or CPTSD
Measured: At the end of the study, an average of 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Refusal by the Ethics Committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Déborah DELABY, Principal investigator, Isarien Hospital Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432400
- Sponsor's protocol ID
- CHRD0824
- Other IDs
- 2024-A00790-47
- Acronym
- IRTIPAP
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 13 Mar 2025
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders Followed up in the Medical and Psychological Centre: Multicentre Descriptive Study
- ClinicalTrials.gov ID
- NCT06432400
- Acronym / sponsor ID
- IRTIPAP / CHRD0824
- Conditions
- Trauma
- Keywords
- Post Traumatic Stress Disorder, Complex post traumatic stress disorder, Medical and Psychological Centre
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Refusal by the Ethics Committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 May 2024 (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.
The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery.
Detailed description
Between 61% and 81% of men and 51% to 74% of women are exposed to a traumatic event in their lifetime. These events may be brief and discrete, prolonged and/or recurrent, and may be direct or indirect. Direct or indirect exposure to traumatic events can lead to serious negative psychological consequences, including post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD). People exposed to complex traumatic events are at risk not only of suffering from PTSD or Complex PTSD, but also from other mental health co-morbidities, such as substance use disorders (drugs, alcohol, benzodiazepine misuse) , often associated with the repetition of situations of interpersonal violence from which it is difficult, if not impossible, to escape.
Caring for people suffering from psychological trauma is a major public health issue. However, there are no good clinical practice guidelines for diagnosis, assessment and treatment, which would enable good practice to be standardised and disseminated. The prevention, detection, early support and appropriate guidance of people suffering from post-traumatic sequelae promote their recovery and improve their quality of life. The World Health Organization (WHO) refers to this as psychological distress, and points out that if it is not properly identified or accompanied, it can tip a person into illness or increase social difficulties. When it is temporary and follows a stressful event, it is considered a normal adaptive reaction. On the other hand, when it becomes intense and persistent, it may be an indicator of a psychological disorder. The public health challenge associated with PTSD is to better recognise, diagnose and treat it, as it can have serious consequences for the quality of life, social functioning and suicide risk of those affected.
The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery. It would also make it possible to provide individualised support for patients and improve their quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Substance use disorders | Other | Other: Patient questionnairesGroup composed of patients suffering from disorders related to the use of alcohol, cannabis, opiates, inhalants, sedatives, hypnotics, anxiolytics, stimulants, hallucinogens (all of these disorders will have been diagnosed by a doctor before or during follow-up according to Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM 5) criteria) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 or over
- Patient followed up at the adult Medical and Psychological Centre in the centres taking part in the study
- Patient suffering from disorders related to the use of alcohol, cannabis, opiates, inhalants, sedatives, hypnotics, anxiolytics, stimulants, hallucinogens (all of these disorders will have been diagnosed by a doctor before or during follow-up according to DSM 5 criteria).
- Patient aware of their substance use disorders
- Patient informed and did not object to participating in the study
Key exclusion criteria (4 listed)
- Patient previously diagnosed with PTSD or CPTSD
- Patient agitated and/or aggressive
- Patient under guardianship/curators
- Patient who do not speak or understand French
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 |
|---|---|---|
| Patient questionnairesPatients questionnaires, on paper and data collection on patients medical file | Other | Substance use disorders |
Primary outcome
Assessment of the proportion of Post-Traumatic Stress Disorder (PTSD) in patients with substance use disorders
Time frame: At the end of the study, an average of 12 month
Percentage of patients with PTSD among those with substance use disorders Patients with PTSD will be identified using the International Trauma Questionnaire (ITQ) : A diagnosis of PTSD requires the presence of at least one symptom in each of the following dimensions * P1 or P2 ≥ 2 * P3 or P4 ≥ 2 * 5 or P6 ≥ 2 AND * P7 or P8 or P9 ≥ 2 Score ITQ for PTSD : ≥ 8
4 secondary outcomes
Distinguishing between the prevalence of Post-Traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD)
Time frame: At the end of the study, an average of 12 month
Identification of risk factors by comparing demographic data of PTSD versus CPTSD patients
Time frame: At the end of the study, an average of 12 month
Identification of the pathologies most associated with PTSD and CPTSD
Time frame: At the end of the study, an average of 12 month
Comparison of the time between management and identification of patients with PTSD versus CPTSD
Time frame: At the end of the study, an average of 12 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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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.
Déborah DELABY principal investigator
Isarien Hospital Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient questionnaires in people with Trauma, run by Hôpital NOVO at 2 sites 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assessment of the proportion of Post-Traumatic Stress Disorder (PTSD) in patients with substance use disorders (time frame: At the end of the study, an average of 12 month). 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 13 Mar 2025.