Study Stopped
Refusal by the Ethics Committee
Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders
IRTIPAP
2 other identifiers
interventional
N/A
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 29, 2024
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 13, 2025
May 1, 2024
1 year
May 22, 2024
March 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Distinguishing between the prevalence of Post-Traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD)
At the end of the study, an average of 12 month
Identification of risk factors by comparing demographic data of PTSD versus CPTSD patients
At the end of the study, an average of 12 month
Identification of the pathologies most associated with PTSD and CPTSD
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
At the end of the study, an average of 12 month
Study Arms (1)
Substance use disorders
OTHERGroup 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)
Interventions
Patients questionnaires, on paper and data collection on patients medical file
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient previously diagnosed with PTSD or CPTSD
- Patient agitated and/or aggressive
- Patient under guardianship/curators
- Patient who do not speak or understand French
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hôpital NOVOlead
Study Sites (2)
Medical and Psychological Centre - Novo Hospital - Site Beaumont-sur-Oise
Beaumont-sur-Oise, 95260, France
Medical and Psychological Centre - Isarien Hospital Centre
Clermont, 60600, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Déborah DELABY
Isarien Hospital Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2024
First Posted
May 29, 2024
Study Start
December 1, 2024
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
March 13, 2025
Record last verified: 2024-05