Empathy in Post-traumatic Stress Disorder in Comparaison to a Control Population

Post-traumatic Stress Disorder Clinical Trial

Official title:

Analysis of Empathy in Patients With Post-traumatic Stress Disorder Followed at the Hospital of Nice: Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05617781
• Other study ID #: 22-PP-19
• Status: Completed
• Start date: July 27, 2023
• Est. completion date: September 29, 2023

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It has been shown in the literature that the symptoms of post-traumatic stress disorder influence the quality of life of patients, in particular through the cognitive alterations they can cause. Social cognition is also itself impacted. It refers to the perception, interpretation and processing of information relating to the social environment and relationships. It is affected by the symptomatology of PTSD both in terms of the response to emotional stimuli, the perception of self and others, and the quality of intimate relationships. These elements lead to reflection on the origin of these alterations, in particular the impact of PTSD on the patient's empathy capacity, defined as the recognition and understanding of the feelings and emotions of another individual. This parameter is also little studied in the literature, only a study dating from 2010 finds a correlation between PTSD and empathy. It is in this context that the realization of a new study studying the capacity for empathy of patients with PTSD in comparison with a control group with a larger and more representative population was envisaged. The primary outcome of this study is to analyze the post-traumatic stress disorder's repercussions on empathy by passing the Interpersonal Reactivity Index (IRI) on patients in comparison with a control group. The first hypothesis is a lower total score but a higher personal distress sub-score in the PTSD population. The secondary outcomes are to describe the cofactors that can influence empathy in association or not with post-traumatic stress disorder: sociodemographic data (age, sex, education level…), traumatic event type determined through the "Inventory of Traumatogenic Events", human intervention, duration and severity of the disorder (evaluated by the Impact of Events Scale) … The number of subjects required was calculated at 19 patients and 19 controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Any patient or controls who score positively off the diagnostic criteria for comorbidities such as major depressive episode, generalized anxiety disorder, psychotic disorder and autism spectrum disorder are not included. These criteria will be assessed through the MINI diagnostic interview and the Autism Spectrum Quotient.

Related Conditions & MeSH terms

• Empathy
• Mental Disorder
• Mental Disorders
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Questionnary
The primary outcome of this study is to analyze the post-traumatic stress disorder's repercussions on empathy by passing the Interpersonal Reactivity Index (IRI)

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interpersonal Reactivity Index (IRI)	The Interpersonal Reactivity Index is a validated self-questionnaire allowing the measurement of empathy from 28 items. For each item, five rating levels are proposed in the form of a Likert scale ranging from 0 ("does not describe me at all") to 4 ("describes me completely"). The IRI is divided into four subscales of seven items corresponding to conceptual adaptation (tendency to spontaneously adopt the point of view of others in daily life), fantasy (tendency to imagine oneself in fictitious situations) , empathic concern (tendency to experience feelings of sympathy and compassion in response to the distress of others) and personal distress (tendency to experience distress and discomfort in response to the distress of others.) The score of each subscale therefore varies from 0 to 28 and the total score of the IRI is between 0 and 112.	1 visit for inclusion