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Anger and Psychotrauma: Data From Military and Civilians (COPMiCiv)

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ClinicalTrials.gov Identifier: NCT04518267
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

Study Description
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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.


Condition or disease Intervention/treatment
Post-traumatic Stress Disorder Behavioral: Structured clinical interview Behavioral: Psychological questionnaires

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anger and Psychotrauma: Data From Military and Civilians
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Civilian group
Participants with civilian status
 Behavioral: Structured clinical interview
A structured clinical interview will be performed at enrollment.

Behavioral: Psychological questionnaires
Several psychological questionnaires will be performed at enrollment.
Military group
Participants with military status
 Behavioral: Structured clinical interview
A structured clinical interview will be performed at enrollment.

Behavioral: Psychological questionnaires
Several psychological questionnaires will be performed at enrollment.


Outcome Measures
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Primary Outcome Measures :
  1. Anxiety score [ Time Frame: At enrollment ]
    Spielberger's State-Trait Anger Expression Inventory-II (STAXI-II) will be used to assess anxiety

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518267


Contacts
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Contact: Anaïs MARMUSE 328382250 ext +33 anais.marmuse@intradef.gouv.fr

Locations
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France
3ème Centre médical des Armées Recruiting
Lille, France, 59001
Contact: Anais MARMUSE    328382250 ext +33    anais.marmuse@intradef.gouv.fr   
Centre Hospitalier de Cadillac Not yet recruiting
Lormont, France, 33310
Contact: Samantha AL JOBOORY, MD       samantha.aljoboory@ch-cadillac.fr   
Centre Hospitalier Léon-Jean Grégory de Thuir Not yet recruiting
Thuir, France, 66301
Contact: Philippe RAYNAUD, MD    468846620 ext +33    philippe.raynaud@ch-thuir.fr   
Groupe Hospitalier Paul Guiraud Not yet recruiting
Villejuif, France, 94806
Contact: Claire GRANIER, MD    142117230 ext +33    granier.claire@hotmail.fr   
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
More Information
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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT04518267    
Other Study ID Numbers: 2019PPRC16
2020-A00507-32 ( Other Identifier: IDRCB )
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders