NCT05400200

Brief Summary

Non-pathological stress has an adaptive value, allowing a person to prepare for the demands of everyday life and increasing chances of survival in the face of danger. To "cope", the individual responds with behavioural, emotional and cognitive strategies (coping strategies). Coping aims to modify the problem causing the stress (problem-focused coping) or to regulate the emotional responses associated with the problem (emotion-focused coping), or it can be focused on avoidance (psychologically and/or physically avoiding the source of the stress). Coping is therefore not positive or negative per se and the strategies used by an individual can be positively or negatively associated with resilience. Thus, the mechanisms by which coping strategies, whether dispositional or situational, induce resilience or, conversely, the development of symptoms linked to stress and PTSD remain poorly understood. To detect and characterize some of these mechanisms, the present research focuses on high-level capacities closely linked to coping and resilience and involved in stress and psychotrauma, namely cognitive control (notably attentional and executive processes that allow for adaptive control of cognition and behaviour) and emotional regulation (processes allowing the triggering, inhibition, maintenance or modulation of emotions). The global research program includes different studies aimed at analyzing and screening for factors, or complexes of factors, that may be involved in the modulation of PTSD symptomatology in adults, based on a dimensional process-oriented and integrative approach. The present study will examine the relationship between the severity and nature of the symptoms of PTSD (e.g. avoidance) and the different processes considered. The primary objective is to examine the impact of the preferential use of habitual coping strategies (emotion-focused, problem-focused or avoidance-focused coping) on the severity of PTSD symptoms. Another objective is to explore the interrelationships, in the modulation of symptoms, between these (specific) coping strategies and the more general and stable self-regulatory capacities, namely emotional regulation and cognitive control. 50 patients aged between 18 and 65 years, followed for a definite diagnosis of PTSD, will participate and complete a set of self-questionnaires and neuropsychological tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 22, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2022

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

Same day

First QC Date

May 27, 2022

Last Update Submit

May 20, 2025

Conditions

Keywords

post-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

  • PTSD severity score : total score of the PCL-5 (Posttraumatic stress disorder Checklist).

    20-item self-report questionnaire that assesses the presence and intensity of PTSD symptoms according to DSM-5 criteria and provides an overall PTSD severity score

    Day 0

Secondary Outcomes (1)

  • PTSD clusters' severity scores

    day 0

Study Arms (1)

questionnary with patients Definite diagnosis of PTSD

OTHER

only patients with diagnosis of PTSD answered questionaries

Diagnostic Test: questionnary administration

Interventions

questionary

questionnary with patients Definite diagnosis of PTSD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Definite diagnosis of PTSD
  • Aged between 18 and 65
  • Stable medication for at least 2 weeks
  • Understand, speak and read French fluently
  • Having signed the informed consent form
  • Being affiliated to the social security system

You may not qualify if:

  • Medical condition that would interfere with the ability to give consent and participate in the study
  • Presence of a mental condition with suicidal risk that requires priority treatment or care
  • Severe psychiatric comorbidity: schizophrenia; bipolar disorder; severe depression
  • Neurological disorders
  • Intellectual disability
  • Pervasive developmental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France, 06000, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • MICHEL BENOIT

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 1, 2022

Study Start

September 22, 2022

Primary Completion

September 22, 2022

Study Completion

December 16, 2024

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations