Clinical trial NCT05268965: Study of Affective Forecasting Skills in Post-traumatic Stress Disorder
Official title: Autonomic and Subjective Correlates of Affective Forecasting Skills in Post-traumatic Stress Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-traumatic Stress Disorder
Keywords: Emotion
Post-traumatic stress disorder
Affective forecasting
Virtual reality
Autonomic nervous system
Electrodermal activity
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects suffering from post-traumatic stress disorder (PTSD)

Brief summary: Post-traumatic stress disorder (PTSD) is associated with a marked tendency to have exaggerated and persistent negative beliefs and expectations about oneself or the world . Although posttraumatic stress symptoms have been shown to be associated with a tendency to negatively anticipate the future, affective forecasting skills (i.e., the ability to predict one's own emotional reactions in response to a future event) have never been explored in PTSD . The hypothesis that the PTSD is associated with a negative affective forecasting bias, characterized by a tendency to predict more intense emotional responses to future negative events.


Eligibility criteria: Inclusion Criteria:

* Understanding and being able to express themselves in French
* Understanding of informed consent and signature of the study participation form
* Giving informed, dated and signed consent
* Benefiting from health insurance coverage
* Normal or corrected visual and auditory acuity to achieve normality
* Group 1 : DSM-5 PTSD criteria, assessed using CAPS and PTSD Checklist for DSM-5 (PCL-5, Weathers \& al., 2013)
* Group 2: PTSD Criteria A only

Exclusion Criteria:

Refusal of participation after clear and fair information on the study.

* Visual or auditory sensory disability to participate in the study.
* Personal history of neurological disease or current neurological disease.
* Personal history of current psychiatric disorder or psychiatric disorder (excluding PTSD in patients in the experimental group), assessed via the MINI.
* Pregnant or breastfeeding women
* Consumption of toxic substances other than tobacco and alcohol.
* Minors or adults under guardianship, under judicial protection, persons deprived of liberty.
* Groups 2 and 3: personal history of psychiatric disorder or current psychiatric disorder and taking psychotropic drugs
* Group 1: personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, trauma and stress-related disorders and treatment with psychotropic drugs not stabilized

Primary outcomes:
measure: difference of arousal assessments measured using the Self-Assessment Manikin between the prediction and emotional experience phases
timeFrame: During the experimental task (2 hours)
Secondary outcomes:
measure: subjective correlates of the affective forecasting bias associated with PTSD changes in: valence scores.
timeFrame: During the experimental task (2 hours)
measure: autonomic correlates of the affective prediction bias associated with PTSD: changes in the skin conductance response and heart rate.
timeFrame: During the experimental task (2 hours)
measure: link between PTSD symptomatology and affective forecasting bias
timeFrame: During the experimental task (2 hours)
measure: link and correlation coefficients between biases measured at the neurovegetative (changes in heart rate and skin conductance) and subjective levels (arousal and valence ratings from the Self-Assessment Manikin) in PTSD
timeFrame: During the experimental task (2 hours)
measure: link and correlation coefficients between affective forecasting bias and emotion regulation skills within each group
timeFrame: During the experimental task (2 hours)
measure: link and correlation coefficients between affective forecasting bias and anxiety and depression
timeFrame: During the experimental task (2 hours)
Other outcomes:
Locations:
city: Lille
country: France
facility: Usn Fontan - Linquette Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Vaiva, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: