Testing the Efficacy of an Eye-tracking-based Treatment in Reducing Stress-related Symptoms in Veterans With PTSD
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Change in PTSD Diagnosis from Pre- to Post-Treatment
研究概览
简要总结
The study will examine the efficacy of a feedback-based treatment applying eye-tracking (Gaze-Contingent Music Reward Therapy) to change attention and gaze patterns associated with angry faces relative to a response-time-based attention bias modification treatment applying the dot-probe task and a control group.
详细描述
The study will recruit veterans with posttraumatic stress disorder (PTSD) due to a trauma acquired during military service. A compatibility check and initial filtering will happen via phone call, using basic symptom questionnaires for self-report and initial examination of exclusion criteria.
This study has four phases:
- Clinical Assessment - Participants who pass the initial filtering and express a desire to participate in the study will be invited to a structured clinical interview during which clinical and practical inclusion and exclusion criteria will be examined by an independent evaluator (a clinical psychologist). After an explanation about the study and provision of signed informed consent from the participant, the clinical interview (CAPS-5 and MINI) will be conducted and self-report questionnaires will be completed:
- Post-trauma Checklist (PCL) - PTSD symptoms
- Patient Health Questionnaire (PHQ) - Depression Symptoms
- Attention Bias Questionnaire (ABQ) - Attention Patterns
- Attention Control Scale (ACS) - Attention Control
- Attention bias measurement - participants will perform computerized tasks aimed to measure their attention bias prior to treatment.
- Free viewing of 30 matrices each with 16 faces (8 with neutral facial expression and 8 with angry facial expression) while monitoring gaze location with passive eye-tracking technology - duration of this assessment is about 15 minutes.
- Attention bias measurement using a dot-probe task in which two faces are presented on the screen and replaced by an arrow pointing right or left, and the participant has to indicate the arrow's direction by pressing a key - duration of the task is about 5 minutes.
- Generic Flanker attention task, in which a middle arrow is presented with additional arrows to the right and left (for example <<><< or >>>>>) and the participant is asked to identify the direction of the middle arrow by pressing a key - duration of the task is about 5 minutes.
- Attention Training - Next participants will be randomly assigned to one of three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PTSD according to the DSM-5 and related to military service, ages 20-70
排除标准
- •Psychotic or Bipolar disorder, drug and alcohol abuse, high risk of harming self or others, other psychological treatment, vision problems that are not overcome with regular glasses, physical disability that prevents ability to operate computer.
结局指标
主要结局
Change in PTSD Diagnosis from Pre- to Post-Treatment
时间窗: 1.5-2 months
Change in PTSD diagnosis, derived from CAPS-5 corresponding to DSM-5 criteria, from pre- to post-treatment
Clinician-rated PTSD symptoms at 3-month Follow-up
时间窗: 3 Months after treatment completion
Total score on the Clinician Administered PTSD Scale (CAPS-5) at 3-month Follow-up
PTSD Diagnosis at 3-month Follow-up
时间窗: 3 Months after treatment completion
PTSD diagnosis derived from CAPS-5 corresponding to DSM-5 criteria at 3-month Follow-up
Change in Clinician-rated PTSD symptoms from Pre- to Post-Treatment
时间窗: 1.5-2 months
Change in total score on the Clinician Administered PTSD Scale (CAPS-5) from pre- to post-treatment
次要结局
- Change in Patient-rated PTSD symptoms from Pre- to Post-Treatment(1.5-2 months)
- Patient-rated Depression symptoms at 3-month Follow-up(3 Months after treatment completion)
- Patient-rated PTSD symptoms at 3-month Follow-up(3 Months after treatment completion)
- Change in Patient-rated Depression symptoms from Pre- to Post-Treatment(1.5-2 months)
- Pre-treatment Clinical Global Impression Scale(Up to 2 weeks pre-treatment)
- Post-treatment Clinical Global Impression Scale(1-2 weeks post-treatment)
研究者
Yair Bar-Haim
Professor
Tel Aviv University