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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04518267
Other study ID # 2019PPRC16
Secondary ID 2020-A00507-32
Status Recruiting
Phase
First received
Last updated
Start date September 21, 2020
Est. completion date September 2024

Study information

Verified date April 2023
Source Direction Centrale du Service de Santé des Armées
Contact Anaïs MARMUSE
Phone 328382250
Email anais.marmuse@intradef.gouv.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Post-Traumatic Stress Disorder (PTSD) is mainly associated with several emotions such as anger, guilt or shame. By interfering with psychotherapeutic work these emotions can be problematic. When suffering from PTSD, pervasive anger can also have relational consequences. Anger and PTSD are mutually reinforcing: anger can aggravate PTSD symptoms and aggressive behaviours, and conversely, PTSD promotes high levels of anger and aggression. A few explanatory hypotheses have been proposed. In terms of personality factors, anger-treatment may promote the severity of PTSD symptoms and the development of aggressive behaviours. In terms of stressors, exposure to combat and combat-related moral harms could play a role in the relationship between PTSD, anger and traumatic experiences over the course of life. Finally, in clinical terms, in the presence of PTSD, anger and aggressive behaviours may be triggered by substance abuse and depression. Within the Anglo-Saxon literature, it is recognized that both civilians and military personnel with PTSD exhibit high levels of anger, with a possible predominance among military personnel. While we know that anger management mechanisms can be strongly influenced by cultural aspects and the type of event, there is no data in the French population. This study proposes to fill in our knowledge of anger-PSTD relationships in the French population and by comparing civilian and military population.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - To have a PTSD diagnosis - To be at least 18 years of age Exclusion Criteria: - To suffer from trauma-related physical condition (including Traumatic Brain Injury)

Study Design


Intervention

Behavioral:
Structured clinical interview
A structured clinical interview will be performed at enrollment.
Psychological questionnaires
Several psychological questionnaires will be performed at enrollment.

Locations

Country Name City State
France Centre hospitalier d'Arras Arras
France 3ème Centre médical des Armées Lille
France Centre régional psychotrauma Hauts-de-France Lille
France Centre Hospitalier de Cadillac Lormont
France CHU de Nice Nice
France CHU-Lenval hôpitaux Nice
France Centre Hospitalier Léon-Jean Grégory de Thuir Thuir
France Groupe Hospitalier Paul Guiraud Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety score Spielberger's State-Trait Anger Expression Inventory-II (STAXI-II) will be used to assess anxiety At enrollment
Primary PTSD severity score Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS-5) will be used to assess PTSD severity score. CAPS-5 score may range from 0 to 120 with higher scores meaning greater PTSD severity. At enrollment
Primary Number of life traumatic events Life Event Checklist (LEC) will be used to assess the number of traumatic events experienced by participants throughout their lifetime At enrollment
Secondary Aggressivity score Aggressivity Questionnaire (AQ12) will be used to assess aggressivity score. AQ12 score may range from 6 to 72 with higher scores meaning higher aggressivity levels. At enrollment
Secondary Anger Rumination score Anger Rumination Scale (ARS) will be used to assess anger rumination score. ARS score may range from 19 to 76 with higher scores corresponding to greater levels of anger rumination. At enrollment
Secondary Alcohol consumption score Alcohol Use Identification Test (A.U.D.I.T.) will be used to assess alcohol consumption score Score = 5: at risk use; Score = 8 (7 in women): harmful use; Score = 12 (11 in women): likely alcohol dependence At enrollment
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