Evaluation of the Effectiveness of Eye-tracking Assisted Attentional Bias Reduction Therapy on Reducing Symptoms of Post-traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score.
时间窗: Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
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.
次要结局
- 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)
- 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)
- 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)