Effect of Attentional Therapy on Post-traumatic Stress Disorder

Официальное название

Evaluation of the Effectiveness of Eye-tracking Assisted Attentional Bias Reduction Therapy on Reducing Symptoms of Post-traumatic Stress Disorder

Обзор

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

Вмешательства

• Поведенческое 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
• Поведенческое Attention control training (ACT)
  Patients will benefit from the ACT as described above; at each trial, images will remain on screen for 2s.

Первичные конечные точки

• PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score. [Срок оценки: Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: One month after prolonged exposure therapy treatment, up to 6 months after inclusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Hôpital Fontan 2 — Lille

Идентификаторы

NCT: NCT05331534 · 2021_0860 · 2022-A00224-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗