Post-traumatic Stress DisorderTRAUPANCT05268965
Study of Affective Forecasting Skills in Post-traumatic Stress Disorder
An observational study of Post-traumatic Stress Disorder, run by University Hospital, Lille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Experimental: group comparison
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2022to 22 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: subjects suffering from post-traumatic stress disorder (PTSD)
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Experimental: group comparison
- Keywords
- Emotion, Post-traumatic stress disorder, Affective forecasting, Virtual reality, Autonomic nervous system, Electrodermal activity
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: group comparisonBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients meeting DSM-5 criteria for PTSD. | Not described Receives: Behavioral: Experimental: group comparison | |
| Group 2: Healthy controls who experienced a traumatic event but did not meet DSM-5 criteria for PTSD | Not described Receives: Behavioral: Experimental: group comparison | |
| Group 3: Healthy controls who did not experience a traumatic event | Not described Receives: Behavioral: Experimental: group comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the experimental task (2 hours)
Secondary outcomes (6)
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])
Measured: 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.
changes in the skin conductance response and heart rate assessed using a BIOPAC (System, inc).
Measured: During the experimental task (2 hours)
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)
Measured: 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
Measured: During the experimental task (2 hours)
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)
Measured: During the experimental task (2 hours)
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
Measured: During the experimental task (2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start28 Feb 2022
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Vaiva, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268965
- Sponsor's protocol ID
- 2021_0385
- Other IDs
- 2021-A01582-39
- Acronym
- TRAUPA
- Status last verified
- Dec 2025
- First submitted
- 7 Feb 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic and Subjective Correlates of Affective Forecasting Skills in Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05268965
- Acronym / sponsor ID
- TRAUPA / 2021_0385
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Emotion, Post-traumatic stress disorder, Affective forecasting, Virtual reality, Autonomic nervous system, Electrodermal activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- subjects suffering from post-traumatic stress disorder (PTSD)
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | 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. |
Primary outcome
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
6 secondary outcomes
subjective correlates of the affective forecasting bias associated with PTSD changes in: valence scores.
Time frame: 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)
link between PTSD symptomatology and affective forecasting bias
Time frame: 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)
link and correlation coefficients between affective forecasting bias and emotion regulation skills within each group
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Vaiva, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-traumatic Stress Disorder, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.