NCT07851090

Brief Summary

This is a single-center cross-sectional study conducted on a sample of former military personnel who had been diagnosed with PTSD. The main objective of this study is to test a mediation model positing that PTSD increases individuals' levels of anger through its detrimental effect on social cognitive abilities (Quantitative component). The secondary objectives focus on the impact of alcohol consumption and ACE on the three components (theory of mind, emotional decoding, empathy) of social cognition (qualitative component). A second secondary objective aims to explore the moral harms reported by former military personnel through a qualitative analysis of semi-structured interviews (qualitative component). Primary Objective (Quantitative Component): To examine the links between PTSD, anger, and social cognition among French veterans using mediation analyses. The aim is to test whether PTSD (independent variable) indirectly influences individuals' levels of anger (dependent variable) through its effect on social cognition (mediating variable). Secondary Objectives:

  • Quantitative component: to examine other factors associated with PTSD that may influence social cognitive abilities, such as alcohol consumption and experiences of childhood abuse (Abuse Childhood Experience-ACE);
  • Qualitative component: to explore the psychological trauma experienced by military personnel through a qualitative analysis of semi-structured interviews. Evaluation criteria: Main Components: Quantitative Component Self-report scales for PTSD, anger, and empathy, as well as two social cognition tasks:
  • PCL-5 - Posttraumatic Checklist-5
  • STAXI-2 - Spielberger's State-Trait Anger Expression Inventory-2
  • EQ - Empathy Quotient
  • MASC - Movie for the Assessment of Social Cognition
  • TREF - Facial Emotion Recognition Test Secondary:
  • Quantitative component
  • AUDIT - Alcohol Use Disorders Identification Test
  • ACE-IQ - Adverse Childhood Experiences-International Questionnaire
  • HADS - Hospital Anxiety and Depression Scale
  • Qualitative component - Content of verbatim transcripts from semi-structured interviews

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
39mo left

Started May 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
May 2025Nov 2029

Study Start

First participant enrolled

May 30, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

4.5 years

First QC Date

August 24, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

PTSDSocial CognitionAngerveterans

Outcome Measures

Primary Outcomes (8)

  • PCL-5 score

    Post-Traumatic Stress Disorder Checklist for DSM-5 score to evaluate PTSD symptom severity.

    1 week post-enrollment (at Visit 3)

  • STAXI-2 Score

    State-Trait Anger Expression Inventory-2 score to evaluate anger expression.

    1 week post-enrollment (at Visit 3)

  • EQ score

    Empathy Quotient score to evaluate empathy.

    1 week post-enrollment (at Visit 3)

  • MASC score

    Movie for the Assessment of Social Cognition score to evaluate social cognition.

    1 week post-enrollment (at Visit 3)

  • TREF score

    Test de Reconnaissance des Émotions Faciales score to evaluate facial emotion recognition.

    1 week post-enrollment (at Visit 3)

  • AUDIT score

    Alcohol Use Disorders Identification Test score to evaluate alcohol consumption.

    1 week post-enrollment (at Visit 3)

  • ACE-IQ score

    Adverse Childhood Experiences International Questionnaire score.

    1 week post-enrollment (at Visit 3)

  • HADS score

    Hospital Anxiety and Depression Scale score to evaluate anxiety and depression.

    1 week post-enrollment (at Visit 3)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

These are former French military personnel who have been out of active duty for more than 6 months and are receiving a military disability pension for PTSD.

You may qualify if:

  • Be of legal age and between 18 and 45 years old;
  • Be able to speak, read, and write French;
  • Have given oral consent after receiving an oral explanation of the study's objectives and procedures;
  • Sign a written, informed, and electronic consent form after reviewing an information sheet explaining the study's objectives and procedures;
  • Be enrolled in a social security program;
  • Receive a military disability pension (PMI) (temporary or permanent) of 20% or more.
  • Additional criterion for the qualitative component: reporting having been exposed to events that could be morally harmful (verified through a specific question in the sociodemographic questionnaire).

You may not qualify if:

  • Pregnant and breastfeeding women;
  • Minors;
  • Individuals under administrative or judicial supervision;
  • Adults under legal guardianship;
  • Reservists who have not previously served on active duty;
  • Individuals who cannot be contacted in an emergency;
  • Physical conditions related to trauma, including head injuries;
  • Participants with a comorbid psychotic disorder;
  • Participants who regularly use illicit drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmuse Anaïs

Draguignan, 83300, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Anaïs Marmuse, PhD

    Service Santé des Armées

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

August 24, 2026

First Posted

October 1, 2026

Study Start

May 30, 2025

Primary Completion (Estimated)

November 30, 2029

Study Completion (Estimated)

November 30, 2029

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations