- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05268965
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
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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 Locations
-
-
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Lille, France
- Usn Fontan - Linquette Chu Lille
-
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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
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 |
Intervention / Treatment |
|---|---|
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Patients meeting DSM-5 criteria for PTSD.
|
Task / affective forecasting:
|
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Group 2: Healthy controls who experienced a traumatic event but did not meet DSM-5 criteria for PTSD
|
Task / affective forecasting:
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Group 3: Healthy controls who did not experience a traumatic event
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Task / affective forecasting:
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What is the study measuring?
Primary Outcome Measures
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
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During the experimental task (2 hours)
|
Secondary Outcome Measures
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).
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During the experimental task (2 hours)
|
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link between PTSD symptomatology and affective forecasting bias
Time Frame: During the experimental task (2 hours)
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PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS-5) and PTSD Checklist for DSM-5 (PCL-5)
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During the experimental task (2 hours)
|
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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)
|
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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
Investigators
- 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)
February 28, 2022
Primary Completion (Actual)
November 22, 2023
Study Completion (Actual)
November 22, 2023
Study Registration Dates
First Submitted
February 7, 2022
First Submitted That Met QC Criteria
February 24, 2022
First Posted (Actual)
March 7, 2022
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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