- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518267
Anger and Psychotrauma: Data From Military and Civilians (COPMiCiv)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Anais MARMUSE
- Phone Number: +33 328382250
- Email: anais.marmuse@intradef.gouv.fr
Study Locations
-
-
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Arras, France, 62000
- Recruiting
- Centre Hospitalier D'arras
-
Contact:
- Laure ROUGEGREZ, MD
- Phone Number: +33 321211070
- Email: laure.rougegrez@gh-artoisternois.fr
-
Lille, France, 59001
- Recruiting
- 3ème Centre médical des Armées
-
Contact:
- Anais MARMUSE
- Phone Number: +33 328382250
- Email: anais.marmuse@intradef.gouv.fr
-
Lille, France, 59000
- Recruiting
- Centre régional psychotrauma Hauts-de-France
-
Contact:
- Frédérique WAREMBOURG, MD
- Phone Number: +33 320445557
- Email: frederique.warembourg@chru-lille.fr
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Lormont, France, 33310
- Not yet recruiting
- Centre Hospitalier de Cadillac
-
Contact:
- Samantha AL JOBOORY, MD
- Email: samantha.aljoboory@ch-cadillac.fr
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Nice, France, 06001
- Recruiting
- Chu de Nice
-
Contact:
- Jérémy BRIDE
- Phone Number: +33 692033335
- Email: bride.j@chu-nice.fr
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Nice, France, 06200
- Recruiting
- CHU-Lenval hôpitaux
-
Contact:
- Morgane GINDT
- Phone Number: +33 492030066
- Email: morgane.gindt@hpu.lenval.com
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Thuir, France, 66301
- Not yet recruiting
- Centre Hospitalier Léon-Jean Grégory de Thuir
-
Contact:
- Philippe RAYNAUD, MD
- Phone Number: +33 468846620
- Email: philippe.raynaud@ch-thuir.fr
-
Villejuif, France, 94806
- Not yet recruiting
- Groupe Hospitalier Paul Guiraud
-
Contact:
- Claire GRANIER, MD
- Phone Number: +33 142117230
- Email: granier.claire@hotmail.fr
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Civilian group
Participants with civilian status
|
A structured clinical interview will be performed at enrollment.
Several psychological questionnaires will be performed at enrollment.
|
Military group
Participants with military status
|
A structured clinical interview will be performed at enrollment.
Several psychological questionnaires will be performed at enrollment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety score
Time Frame: At enrollment
|
Spielberger's State-Trait Anger Expression Inventory-II (STAXI-II) will be used to assess anxiety
|
At enrollment
|
PTSD severity score
Time Frame: At enrollment
|
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
Time Frame: At enrollment
|
Life Event Checklist (LEC) will be used to assess the number of traumatic events experienced by participants throughout their lifetime
|
At enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aggressivity score
Time Frame: At enrollment
|
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
|
Anger Rumination score
Time Frame: At enrollment
|
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
|
Alcohol consumption score
Time Frame: At enrollment
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019PPRC16
- 2020-A00507-32 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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