Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05400200
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2022-05-27
Brief Title:
PTSD and Self-regulation Coping Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESIT
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 andor 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 eg 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
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 eg 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 eventemotional 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 andor 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 andor 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 eg 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 andor traumatic event
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 eventemotional 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 andor 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 andor 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 eg 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 andor traumatic event
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None