Mental DisorderNCT05617781
Empathy in Post-traumatic Stress Disorder in Comparaison to a Control Population
An observational study of Mental Disorder and Post-traumatic Stress Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Post-traumatic Stress Disorder, Empathy
- What is being tested?
- Questionnary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2023to 29 Sep 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mental Disorder, Post-traumatic Stress Disorder, Empathy
- Being tested
- Questionnary
- Medical subject headings
- Mental Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaryBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Behavioral: Questionnary | |
| Patient | Not described Receives: Behavioral: Questionnary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 visit for inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start27 Jul 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617781
- Sponsor's protocol ID
- 22-PP-19
- Status last verified
- Jan 2024
- First submitted
- 3 Nov 2022
- Last updated
- 31 Jan 2024
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Empathy in Patients With Post-traumatic Stress Disorder Followed at the Hospital of Nice: Case-control Study
- ClinicalTrials.gov ID
- NCT05617781
- Acronym / sponsor ID
- 22-PP-19
- Conditions
- Mental Disorder, Post-traumatic Stress Disorder, Empathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 15 Nov 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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Behavioral: Questionnary |
| Patient | – | Behavioral: Questionnary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
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 |
|---|---|---|
| QuestionnaryThe primary outcome of this study is to analyze the post-traumatic stress disorder's repercussions on empathy by passing the Interpersonal Reactivity Index (IRI) | Behavioural | Control, Patient |
Primary outcome
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.
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 31 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder and Post-traumatic Stress Disorder, 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?
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 31 Jan 2024. 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?
Interpersonal Reactivity Index (IRI) (time frame: 1 visit for inclusion). 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 31 Jan 2024.