Study of Affective Forecasting Skills in Post-traumatic Stress Disorder

Post-traumatic Stress Disorder Clinical Trial

— TRAUPA  

Official title:

Autonomic and Subjective Correlates of Affective Forecasting Skills in Post-traumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268965
• Other study ID #: 2021_0385
• Secondary ID: 2021-A01582-39
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: April 2024

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Guillaume Vaiva, MD,PhD
• Phone: 0320445962
• Email: guillaume.vaiva[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Experimental: group comparison
Standardized psychiatric interview (Mini International Neuropsychiatric Interview MINI) State-Trait-Anxiety Inventory (Spielberger, 1993) Beck Depression Inventory (BDI-II, 1998) Cognitive Emotional Regulation Questionnaire (Jermann & al., 2006) Participant installation and testing: 2 stages (forecasting on a computer, and exposure in virtual reality) Task / affective forecasting: Step 1: forecasting about one's own emotional responses regarding pleasant, neutral and unpleasant scenarios Step 2: experience of the same scenarios in virtual reality

Locations

Country	Name	City	State
France	Usn Fontan - Linquette Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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