- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05617781
Empathy in Post-traumatic Stress Disorder in Comparaison to a Control Population
January 30, 2024 updated by: Centre Hospitalier Universitaire de Nice
Analysis of Empathy in Patients With Post-traumatic Stress Disorder Followed at the Hospital of Nice: Case-control Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Nice, France, 06001
- CHU de Nice
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The patients included will be followed at the Hospital of Nice for post-traumatic stress disorder diagnosed according to the DSM-V criteria.
They are volunteers, adults, French speakers.
The control population will be randomly selected (advertising, social networks…), adults and French speakers too, having no follow-up or current psychiatric treatment.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control
|
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)
|
|
Patient
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interpersonal Reactivity Index (IRI)
Time Frame: 1 visit for inclusion
|
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.
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1 visit for inclusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 27, 2023
Primary Completion (Actual)
September 29, 2023
Study Completion (Actual)
September 29, 2023
Study Registration Dates
First Submitted
November 3, 2022
First Submitted That Met QC Criteria
November 10, 2022
First Posted (Actual)
November 15, 2022
Study Record Updates
Last Update Posted (Actual)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-PP-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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