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

December 4, 2025 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Lille, France
        • Usn Fontan - Linquette Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

subjects suffering from post-traumatic stress disorder (PTSD)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
difference of arousal assessments measured using the Self-Assessment Manikin between the prediction and emotional experience phases
Time Frame: During the experimental task (2 hours)
To compare the subjective affective forecasting bias between the PTSD group and the two control groups
During the experimental task (2 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
subjective correlates of the affective forecasting bias associated with PTSD changes in: valence scores.
Time Frame: 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])
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.
Time Frame: During the experimental task (2 hours)
changes in the skin conductance response and heart rate assessed using a BIOPAC (System, inc).
During the experimental task (2 hours)
link between PTSD symptomatology and affective forecasting bias
Time Frame: 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)
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
Time Frame: During the experimental task (2 hours)
During the experimental task (2 hours)
link and correlation coefficients between affective forecasting bias and emotion regulation skills within each group
Time Frame: During the experimental task (2 hours)
affective forecasting bias and emotion regulation skills, assessed using the Cognitive Emotional Regulation Questionnaire (CERQ)
During the experimental task (2 hours)
link and correlation coefficients between affective forecasting bias and anxiety and depression
Time Frame: 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
During the experimental task (2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillaume Vaiva, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021_0385
  • 2021-A01582-39 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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