Study of Affective Forecasting Skills in Post-traumatic Stress Disorder

NCT05268965 | Completed

• 2 other identifiers: 2021_03852021-A01582-39
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Keywords

Emotion; Post-traumatic stress disorder; Affective forecasting; Virtual reality; Autonomic nervous system; Electrodermal activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• subjective correlates of the affective forecasting bias associated with PTSD changes in: valence scores.

  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)

• link between PTSD symptomatology and affective forecasting bias

  During the experimental task (2 hours)

• 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)

Study Arms (3)

Patients meeting DSM-5 criteria for PTSD.

Behavioral: Experimental: group comparison

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

Interventions

Experimental: group comparison BEHAVIORAL

* 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; Group 3: Healthy controls who did not experience a traumatic event; Patients meeting DSM-5 criteria for PTSD.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

subjects suffering from post-traumatic stress disorder (PTSD)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Usn Fontan - Linquette Chu Lille

Lille, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Guillaume Vaiva, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 7, 2022
• Study Start: February 28, 2022
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)