Study of Affective Forecasting Skills in Post-traumatic Stress Disorder

NCT ID: NCT05268965

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-28

Study Completion Date

2023-11-22

Brief Summary

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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.

Detailed Description

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Conditions

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Post-traumatic Stress Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients meeting DSM-5 criteria for PTSD.

Experimental: group comparison

Intervention Type 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

Group 2: Healthy controls who experienced a traumatic event but did not meet DSM-5 criteria for PTSD

Experimental: group comparison

Intervention Type 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

Group 3: Healthy controls who did not experience a traumatic event

Experimental: group comparison

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Vaiva, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Usn Fontan - Linquette Chu Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2021-A01582-39

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0385

Identifier Type: -

Identifier Source: org_study_id

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