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CompletedNCT05268965TRAUPAUpdated Dec 5, 2025

Study of Affective Forecasting Skills in Post-traumatic Stress Disorder

An observational study in Post-traumatic Stress Disorder, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
97
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Post-traumatic Stress Disorder

Keywords

  • Emotion
  • Post-traumatic stress disorder
  • Affective forecasting
  • Virtual reality
  • Autonomic nervous system
  • Electrodermal activity
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In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 97 is below the median of 136 across 295 observational studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

subjects suffering from post-traumatic stress disorder (PTSD)

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
97 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralExperimental: 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

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What researchers measure

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

    Time frame: During the experimental task (2 hours)

Secondary outcomes

  1. 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 \[very pleasant\])

    Time frame: During the experimental task (2 hours)

  2. 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).

    Time frame: During the experimental task (2 hours)

  3. 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)

    Time frame: During the experimental task (2 hours)

  4. 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)

  5. 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)

    Time frame: During the experimental task (2 hours)

  6. 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

    Time frame: During the experimental task (2 hours)

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Study locations

1 site
  • Usn Fontan - Linquette Chu Lille
    Lille, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05268965
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Mar 7, 2022
Start date
Feb 28, 2022
Primary completion
Nov 22, 2023
Completion
Nov 22, 2023
Last update
Dec 5, 2025

Study contacts

Guillaume Vaiva, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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