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Completed

NCT Number: NCT05268965

Study 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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Usn Fontan - Linquette Chu Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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])

  2. 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).

  3. 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)

  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

    Time frame: During the experimental task (2 hours)

    affective forecasting bias and emotion regulation skills, assessed using the Cognitive Emotional Regulation Questionnaire (CERQ)

  6. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: TRAUPA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2022
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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