Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders

Post Traumatic Stress Disorder Clinical Trial

— IRTIPAP  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance-Related Disorders

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