Effect of Attentional Therapy on Post-traumatic Stress Disorder

NCT05331534 | Recruiting

• 2 other identifiers: 2021_08602022-A00224-39
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Post-traumatic stress disorder (PTSD) is associated with an attentional bias towards negative stimuli, which is supposed to contribute to the development and the maintenance of the disorder. We recently showed using eye-tracking evidenced two types of AB towards negative stimuli: a "physiological AB" found both in healthy and individual with PTSD, characterized by a stronger initial attentional engagement towards negative stimuli compared to neutral stimuli, as revealed by longer first fixation duration dwell time on negative pictures than on neutral pictures; a "pathological bias" observed only in individuals with PTSD and characterized by an heightened sustained attention towards negative stimuli once detected, which further increases with prolonged exposure. The present study aimed at assessing the effectiveness of an eye-tracking assisted attentional bias reduction therapy, targeting specifically the pathological bias on the reduction of PTSD symptoms

Conditions

Post Traumatic Stress Disorder

Keywords

Post-traumatic stress disorder; Attentional bias; Eye tracking; Attention Control Training

Outcome Measures

Primary Outcomes (1)

• PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score.

  The CAPS-5 is a 30-item structured interview corresponding to the DSM-5 diagnosis for PTSD. The CAPS-5 combines information about frequency and intensity of an item into a single severity rating (range 0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster. Higher scores thus correspond to higher severity of PTSD symptoms.

  Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion

Secondary Outcomes (4)

• AB will be assessed in both groups by measuring the total fixation time on negative versus neutral images in a dot-probe task with eye tracking

  Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion

• Calculation of correlation coefficients between pre- and post-treatment differences in AB and PTSD

  Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion

• The number of sessions of prolonged exposure therapy required to achieve a score below the clinical cut-off at the PTSD Checklist for DSM-5 (PCL5) (<33/80)

  Before each prolonged exposure therapy session: 1 month after inclusion, during 3 months on average

• Follow-up on psychotraumatic symptomatology will be assessed using the Clinician-Administered PTSD Scale (CAPS) score

  One month after prolonged exposure therapy treatment, up to 6 months after inclusion

Study Arms (2)

patients with a PTSD receiving ACTo and prolonged exposure therapy.

EXPERIMENTAL

Behavioral: Eye-tracking assisted attention control training (ACTo)

patients with PTSD receiving ACT and prolonged exposure therapy.

SHAM COMPARATOR

Behavioral: Attention control training (ACT)

Interventions

Eye-tracking assisted attention control training (ACTo) BEHAVIORAL

ACT is made of 8 sessions of a Dot-Probe Task (DPT). The DPT is a computerized task in which two visual stimuli (one emotional stimulus and one neutral stimulus) are displayed simultaneously on the left and right side of the screen. AB towards or away from emotional stimuli is respectively inferred by faster or slower responses to detect a probe replacing an emotional stimulus than a probe replacing a neutral stimulus. In the ACT therapy, the probe replaces the negative and neutral stimuli with equal frequency. ACTo will combine ACT with eye tracking methodology, allowing to directly record eye movements of the participants during the task. At each trial, images will be displayed for 2s and the negative image will be replaced by the neutral image (and vice versa) if the patient continues to explore the negative image beyond the first fixation, in order to block any additional attentional engagement.

patients with a PTSD receiving ACTo and prolonged exposure therapy.

Attention control training (ACT) BEHAVIORAL

Patients will benefit from the ACT as described above; at each trial, images will remain on screen for 2s.

patients with PTSD receiving ACT and prolonged exposure therapy.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Understanding and able to express themselves in French
• Giving informed consent, by dating and signing the study participation form
• Having health insurance coverage
• Normal or corrected to normal vision and hearing
• DSM-5 PTSD criteria, assessed using the CAPS and PCL-5

You may not qualify if:

• Minors or adults under guardianship, under judicial protection, persons deprived of liberty
• Pregnant or breastfeeding women
• Refusal to participate after being clearly and fairly informed about the study
• Sensory, visual or auditory incapacity to participate in the study
• Personal history of neurological disorder or current neurological disorder
• Use of drugs other than tobacco and alcohol
• Alcohol use on the day of experimentation
• Personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, or trauma and stress disorders assessed at clinical interview and with MINI
• Personal history of multiple trauma in childhood
• Psychotropic medication treatment not stabilized over the past 4 weeks
• MOCA \< 26
• Contraindication to prolonged exposure therapy

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Fontan 2

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Guillaume Vaiva, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume VAIVA, MD,PhD

CONTACT

0320445962; guillaume.vaiva@chru-lille.fr

Fabien D'HONDT, PhD

CONTACT

fabien.d-hondt@univ-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 15, 2022
• Study Start: February 2, 2024
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): February 2, 2029
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)