## Protocol Section
### Identification Module
**NCT ID:** NCT06432400

**Acronym:** IRTIPAP

**Brief Title:** Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders

**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

#### Organization Study ID Info
**ID:** CHRD0824
#### Organization
**Class:** OTHER
**Full Name:** Hôpital NOVO
#### Secondary ID Infos
**Domain:** ANSM
**ID:** 2024-A00790-47
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hôpital NOVO

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Post Traumatic Stress Disorder

**Keywords:**

- Post Traumatic Stress Disorder

- Complex post traumatic stress disorder

- Medical and Psychological Centre

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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)

**Intervention Names:**

- Other: Patient questionnaires

**Label:** Substance use disorders

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Substance use disorders

**Description:** Patients questionnaires, on paper and data collection on patients medical file

**Name:** Patient questionnaires

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** 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

#### Secondary Outcomes

**Description:** 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

**Measure:** 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

**Description:** Risk factors will be identified from the demographic data collected via the patient characteristics questionnaire between PTSD and CPTSD patients

**Measure:** 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

**Description:** The pathologies most frequently associated with PTSD and CPTSD will be identified by collecting the pathologies present in the medical records of all patients.

**Measure:** Identification of the pathologies most associated with PTSD and CPTSD

**Time Frame:** At the end of the study, an average of 12 month

**Description:** Comparison for number of days between the start of treatment for substance use disorders and the identification of PTSD or CPTSD

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** maryline.delattre@ght-novo.fr

**Name:** Maryline DELATTRE

**Phone:** +3333130754131

**Role:** CONTACT

**Contact 2:**

**Email:** veronique.dacosta@ght-novo.fr

**Name:** Véronique DA COSTA

**Phone:** +3333130755069

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beaumont-sur-Oise

**Contacts:**

***Contact 1:***

- **Email:** benjamin.schmidt@ght-novo.fr

- **Name:** Benjamin Schmidt

- **Phone:** +33 1 39 37 15 20

- **Role:** CONTACT

**Country:** France

**Facility:** Medical and Psychological Centre - Novo Hospital - Site Beaumont-sur-Oise

**Zip:** 95260

**Location 2:**

**City:** Clermont

**Contacts:**

***Contact 1:***

- **Email:** deborahdelaby@gmail.com

- **Name:** Deborah DELABY

- **Phone:** +33 6 09 62 50 12

- **Role:** CONTACT

**Country:** France

**Facility:** Medical and Psychological Centre - Isarien Hospital Centre

**Zip:** 60600

#### Overall Officials

**Official 1:**

**Affiliation:** Isarien Hospital Centre

**Name:** Déborah DELABY

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: HIGH

- As Found: Traumatic Stress Disorder

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Post Traumatic Stress Disorder

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: HIGH

- As Found: Substance Use Disorders

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

### Intervention Browse Module - Browse Branches

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

- ID: M9305

- Name: Hallucinogens

- Relevance: LOW

- As Found: Unknown

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M16905

- Name: Anti-Anxiety Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27371

- Name: Opiate Alkaloids

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
