NCT06432400

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 13, 2025

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 22, 2024

Last Update Submit

March 10, 2025

Conditions

Keywords

Post Traumatic Stress DisorderComplex post traumatic stress disorderMedical and Psychological Centre

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

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)

Other: Patient questionnaires

Interventions

Patients questionnaires, on paper and data collection on patients medical file

Substance use disorders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (2)

Medical and Psychological Centre - Novo Hospital - Site Beaumont-sur-Oise

Beaumont-sur-Oise, 95260, France

Location

Medical and Psychological Centre - Isarien Hospital Centre

Clermont, 60600, France

Location

MeSH Terms

Conditions

Wounds and InjuriesStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Déborah DELABY

    Isarien Hospital Centre

    PRINCIPAL INVESTIGATOR
0

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

Locations