NCT04518267

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

3.9 years

First QC Date

August 15, 2020

Last Update Submit

April 27, 2023

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

  • Anxiety score

    Spielberger's State-Trait Anger Expression Inventory-II (STAXI-II) will be used to assess anxiety

    At enrollment

  • 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

  • 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 Outcomes (3)

  • Aggressivity score

    At enrollment

  • Anger Rumination score

    At enrollment

  • Alcohol consumption score

    At enrollment

Study Arms (2)

Civilian group

Participants with civilian status

Behavioral: Structured clinical interviewBehavioral: Psychological questionnaires

Military group

Participants with military status

Behavioral: Structured clinical interviewBehavioral: Psychological questionnaires

Interventions

Structured clinical interviewBEHAVIORAL

A structured clinical interview will be performed at enrollment.

Civilian groupMilitary group
Psychological questionnairesBEHAVIORAL

Several psychological questionnaires will be performed at enrollment.

Civilian groupMilitary group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be composed of participants suffering from PTSD, half of which will have civilian status and the other half a military status.

You may qualify if:

  • To have a PTSD diagnosis
  • To be at least 18 years of age

You may not qualify if:

  • To suffer from trauma-related physical condition (including Traumatic Brain Injury)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Centre hospitalier d'Arras

Arras, 62000, France

RECRUITING

Centre régional psychotrauma Hauts-de-France

Lille, 59000, France

RECRUITING

3ème Centre médical des Armées

Lille, 59001, France

RECRUITING

Centre Hospitalier de Cadillac

Lormont, 33310, France

NOT YET RECRUITING

CHU de Nice

Nice, 06001, France

RECRUITING

CHU-Lenval hôpitaux

Nice, 06200, France

RECRUITING

Centre Hospitalier Léon-Jean Grégory de Thuir

Thuir, 66301, France

NOT YET RECRUITING

Groupe Hospitalier Paul Guiraud

Villejuif, 94806, France

NOT YET RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Anaïs MARMUSE

CONTACT

328382250anais.marmuse@intradef.gouv.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2020

First Posted

August 19, 2020

Study Start

September 21, 2020

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

FR(8)