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

March 10, 2025 updated by: Hôpital NOVO

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Beaumont-sur-Oise, France, 95260
        • Medical and Psychological Centre - Novo Hospital - Site Beaumont-sur-Oise
      • Clermont, France, 60600
        • Medical and Psychological Centre - Isarien Hospital Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Substance use disorders
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)
Other: Patient questionnaires
Patients questionnaires, on paper and data collection on patients medical file

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of the study, an average of 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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
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
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
Identification of the pathologies most associated with PTSD and CPTSD
Time Frame: At the end of the study, an average of 12 month
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital NOVO

Investigators

  • Principal Investigator: Déborah DELABY, Isarien Hospital Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD0824
  • 2024-A00790-47 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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