Effect of Attentional Therapy on Post-traumatic Stress Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eye-tracking assisted attention control training (ACTo), Attention control training (ACT).
- Who it may be relevant to
- Registry conditions: Post Traumatic Stress Disorder. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Effectiveness of Eye-tracking Assisted Attentional Bias Reduction Therapy on Reducing Symptoms of Post-traumatic Stress Disorder
Overview
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
Interventions
- Behavioral Eye-tracking assisted attention control training (ACTo)
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 - Behavioral Attention control training (ACT)
Patients will benefit from the ACT as described above; at each trial, images will remain on screen for 2s.
Primary outcome measures
- PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score. [Time frame: Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion]
Secondary outcome measures (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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: One month after prolonged exposure therapy treatment, up to 6 months after inclusion]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 1 center
- Hôpital Fontan 2 — Lille
Identifiers
NCT: NCT05331534 · 2021_0860 · 2022-A00224-39