Stress Disorders, Post-TraumaticRESITNCT05400200
PTSD and Self-regulation: Coping, Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management
A study testing questionnary administration in people with Stress Disorders, Post-Traumatic, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- questionnary administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2022to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Involvement of Cognitive, Emotional, and Behavioural Self-regulation and Control Capacities in the Modulation of Post-traumatic Stress Disorder Symptomatology in Adults: Processual and Integrative Approach
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.
Read the detailed description
Numerous epidemiological studies confirm that psychological trauma is a ubiquitous phenomenon and many researchers consider exposure to trauma to be the norm rather than the exception. However, not all individuals exposed to a traumatic event will develop PTSD and not all will react in the same way to an identical event: some may be resilient while others will develop symptoms of varying nature, intensity and duration.
PTSD symptoms are often seen as a stress response that remains disrupted and maladaptive in the absence of the event that provoked it, and some approaches view reactions to psychotrauma along a continuum from a normal coping response to stress to chronic PTSD.
Non-pathological stress has an adaptive value, allowing a person to prepare for the demands of everyday life and increasing the chances of survival in the face of danger. To "cope", the individual responds with behavioural, emotional and cognitive strategies (coping strategies). Conceived as a moderator of the stressful event/emotional distress relationship, coping is defined by classical approaches as a multidimensional, dynamic and specific process and not a general and stable characteristic.
Recently, a second way of modelling coping has emerged, which refers to dispositional adjustment (or trait adjustment) and assumes that individuals develop habits for coping with stress and threat and that these habits or adjustment styles can affect their response in new situations. The latter approach seems to be more appropriate because dispositional coping measures are shown to be more stable over time.
Coping can be used 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). It is therefore not positive or negative per se, and the strategies used by an individual can be positively or negatively associated with resilience. To date, however, 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.
Firstly, emotions are inherent to stress and trauma and their regulation is initiated to reduce an unpleasant experience in order to produce an adapted behaviour. In addition, cognitive control is involved whenever we have to deal with new and/or complex situations that we cannot solve automatically and routinely, which is the case when confronted with a traumatic event. It is thus clear that emotional regulation and cognitive control must be efficient to deal with such exceptional events as traumatic ones.
In order to detect and characterize some of these mechanisms, the present research project focuses on high-level capacities closely linked to coping and resilience and involved in stress and psychotrauma, namely cognitive control and emotional regulation.
The main study examines the impact of the preferred use of habitual coping strategies (emotion-focused, problem-focused or avoidance-focused coping) on the severity of PTSD symptoms. The secondary 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 (processes allowing the triggering, inhibition, maintenance or modulation of emotions) and cognitive control (notably attentional and executive processes that allow for adaptive control of cognition and behavior). The study will examine the relationship between the severity and nature of the symptoms of PTSD (e.g. avoidance) and the different processes considered. Fifty patients aged between 18 and 65 years, followed for a definite diagnosis of PTSD, will participate in this study and will complete a set of self-questionnaires and neuropsychological tests.
Despite their importance, and despite the many characteristics that cognitive control, emotional regulation and coping may share, research on these concepts has remained particularly fragmented, not studying these three essential facets together. In an original way, the approach adopted in this project is processual and integrative and considers a set of processes underlying these capacities. A better understanding of these influences on vulnerability to psychological trauma may help to refine conceptual models of PTSD, as each of these factors considered in isolation is likely to play only a small role in the overall resilience capacity or risk of PTSD. A more integrative consideration of stress and trauma management factors may thus help to improve the management and early identification of risk for adverse clinical outcomes and thus alert clinicians to those who may be most in need of prevention or early intervention following exposure to an extremely stressful and/or traumatic event.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- questionnary administration
- Keywords
- post-traumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnary administrationDiagnostic test
questionary
| Study group | Role | What they receive |
|---|---|---|
| questionnary with patients Definite diagnosis of PTSD | Other | only patients with diagnosis of PTSD answered questionaries Receives: Diagnostic Test: questionnary administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (1)
PTSD clusters' severity scores
total score of each sub-scale of the PCL-5.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start22 Sep 2022
- Primary completion22 Sep 2022
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MICHEL BENOIT, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400200
- Sponsor's protocol ID
- 20-PP-29
- Acronym
- RESIT
- Status last verified
- May 2025
- First submitted
- 27 May 2022
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Involvement of Cognitive, Emotional, and Behavioural Self-regulation and Control Capacities in the Modulation of Post-traumatic Stress Disorder Symptomatology in Adults: Processual and Integrative Approach
- ClinicalTrials.gov ID
- NCT05400200
- Acronym / sponsor ID
- RESIT / 20-PP-29
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Numerous epidemiological studies confirm that psychological trauma is a ubiquitous phenomenon and many researchers consider exposure to trauma to be the norm rather than the exception. However, not all individuals exposed to a traumatic event will develop PTSD and not all will react in the same way to an identical event: some may be resilient while others will develop symptoms of varying nature, intensity and duration.
PTSD symptoms are often seen as a stress response that remains disrupted and maladaptive in the absence of the event that provoked it, and some approaches view reactions to psychotrauma along a continuum from a normal coping response to stress to chronic PTSD.
Non-pathological stress has an adaptive value, allowing a person to prepare for the demands of everyday life and increasing the chances of survival in the face of danger. To "cope", the individual responds with behavioural, emotional and cognitive strategies (coping strategies). Conceived as a moderator of the stressful event/emotional distress relationship, coping is defined by classical approaches as a multidimensional, dynamic and specific process and not a general and stable characteristic.
Recently, a second way of modelling coping has emerged, which refers to dispositional adjustment (or trait adjustment) and assumes that individuals develop habits for coping with stress and threat and that these habits or adjustment styles can affect their response in new situations. The latter approach seems to be more appropriate because dispositional coping measures are shown to be more stable over time.
Coping can be used 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). It is therefore not positive or negative per se, and the strategies used by an individual can be positively or negatively associated with resilience. To date, however, 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.
Firstly, emotions are inherent to stress and trauma and their regulation is initiated to reduce an unpleasant experience in order to produce an adapted behaviour. In addition, cognitive control is involved whenever we have to deal with new and/or complex situations that we cannot solve automatically and routinely, which is the case when confronted with a traumatic event. It is thus clear that emotional regulation and cognitive control must be efficient to deal with such exceptional events as traumatic ones.
In order to detect and characterize some of these mechanisms, the present research project focuses on high-level capacities closely linked to coping and resilience and involved in stress and psychotrauma, namely cognitive control and emotional regulation.
The main study examines the impact of the preferred use of habitual coping strategies (emotion-focused, problem-focused or avoidance-focused coping) on the severity of PTSD symptoms. The secondary 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 (processes allowing the triggering, inhibition, maintenance or modulation of emotions) and cognitive control (notably attentional and executive processes that allow for adaptive control of cognition and behavior). The study will examine the relationship between the severity and nature of the symptoms of PTSD (e.g. avoidance) and the different processes considered. Fifty patients aged between 18 and 65 years, followed for a definite diagnosis of PTSD, will participate in this study and will complete a set of self-questionnaires and neuropsychological tests.
Despite their importance, and despite the many characteristics that cognitive control, emotional regulation and coping may share, research on these concepts has remained particularly fragmented, not studying these three essential facets together. In an original way, the approach adopted in this project is processual and integrative and considers a set of processes underlying these capacities. A better understanding of these influences on vulnerability to psychological trauma may help to refine conceptual models of PTSD, as each of these factors considered in isolation is likely to play only a small role in the overall resilience capacity or risk of PTSD. A more integrative consideration of stress and trauma management factors may thus help to improve the management and early identification of risk for adverse clinical outcomes and thus alert clinicians to those who may be most in need of prevention or early intervention following exposure to an extremely stressful and/or traumatic event.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnary with patients Definite diagnosis of PTSD | Other | Diagnostic Test: questionnary administrationonly patients with diagnosis of PTSD answered questionaries |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnary administrationquestionary | Diagnostic test | questionnary with patients Definite diagnosis of PTSD |
Primary outcome
PTSD severity score : total score of the PCL-5 (Posttraumatic stress disorder Checklist).
Time frame: Day 0
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
1 secondary outcome
PTSD clusters' severity scores
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MICHEL BENOIT principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnary administration in people with Stress Disorders, Post-Traumatic, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD severity score : total score of the PCL-5 (Posttraumatic stress disorder Checklist). (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.