Study of Affective Forecasting Skills in Post-traumatic Stress Disorder

• Conditions: Post-traumatic Stress Disorder

• Registration Number: NCT05268965
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-24
• Study Start: 2022-02-28
• Study First Posted: 2022-03-07
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-10
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference of arousal assessments measured using the Self-Assessment Manikin between the prediction and emotional experience phases	During the experimental task (2 hours)	To compare the subjective affective forecasting bias between the PTSD group and the two control groups

Secondary Outcome Measures

Name	Time	Method
link and correlation coefficients between affective forecasting bias and emotion regulation skills within each group	During the experimental task (2 hours)	affective forecasting bias and emotion regulation skills, assessed using the Cognitive Emotional Regulation Questionnaire (CERQ)
subjective correlates of the affective forecasting bias associated with PTSD changes in: valence scores.	During the experimental task (2 hours)	valence scores using the Self-Assessment Manikin (Likert-type scale ranging from 1 \[very unpleasant\] to 9 \[very pleasant\])
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	During the experimental task (2 hours)
autonomic correlates of the affective prediction bias associated with PTSD: changes in the skin conductance response and heart rate.	During the experimental task (2 hours)	changes in the skin conductance response and heart rate assessed using a BIOPAC (System, inc).
link between PTSD symptomatology and affective forecasting bias	During the experimental task (2 hours)	PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS-5) and PTSD Checklist for DSM-5 (PCL-5)
link and correlation coefficients between affective forecasting bias and anxiety and depression	During the experimental task (2 hours)	anxiety and depression, respectively assessed using the State-Trait-Anxiety Inventory (STAI) and the Beck Depression Inventory (BDI-II), within each group

Trial Locations

Locations (1)

Usn Fontan - Linquette Chu Lille; 🇫🇷 Lille, France