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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06432400
Other study ID # CHRD0824
Secondary ID 2024-A00790-47
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date June 2025

Study information

Verified date May 2024
Source Hôpital NOVO
Contact Maryline DELATTRE
Phone +3333130754131
Email maryline.delattre@ght-novo.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria : - 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 Exclusion Criteria : - Patient previously diagnosed with PTSD or CPTSD - Patient agitated and/or aggressive - Patient under guardianship/curators - Patient who do not speak or understand French

Study Design


Intervention

Other:
Patient questionnaires
Patients questionnaires, on paper and data collection on patients medical file

Locations

Country Name City State
France Medical and Psychological Centre - Novo Hospital - Site Beaumont-sur-Oise Beaumont-sur-Oise
France Medical and Psychological Centre - Isarien Hospital Centre Clermont

Sponsors (1)

Lead Sponsor Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
At the end of the study, an average of 12 month
Secondary 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
At the end of the study, an average of 12 month
Secondary 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 At the end of the study, an average of 12 month
Secondary 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. At the end of the study, an average of 12 month
Secondary 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 At the end of the study, an average of 12 month
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