TRAUPA: Study of Affective Forecasting Skills in Post-traumatic Stress Disorder

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05268965

Collaborator

(none)

108

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder	Behavioral: Experimental: group comparison

Study Design

Study Type:

Observational

Anticipated Enrollment :

108 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients meeting DSM-5 criteria for PTSD.	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
Group 2: Healthy controls who experienced a traumatic event but did not meet DSM-5 criteria for PTSD	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
Group 3: Healthy controls who did not experience a traumatic event	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

Arm

Intervention/Treatment

Patients meeting DSM-5 criteria for PTSD.

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

Group 2: Healthy controls who experienced a traumatic event but did not meet DSM-5 criteria for PTSD

Behavioral: Experimental: group comparison

Group 3: Healthy controls who did not experience a traumatic event

Behavioral: Experimental: group comparison

Outcome Measures

Primary Outcome Measures

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

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])
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 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)]
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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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