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
- 1
- 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.
研究组 & 干预措施
Gaze-Contingent Feedback Training
In the task, 30 different matrices, each consisting of 16 faces, will be presented. Each matrix includes 8 angry faces and 8 neutral, 8 women and 8 men, and the locations are counterbalanced between matrices. The participants are asked to view the matrices in any way they choose, and the eye-tracking camera records their viewing location relative to the stimuli presented on the screen. At the beginning of each training session, the veteran will choose to which music he would like to listen during the 12-minute session from a diverse list of music. After calibrating the eye-tracking technology, the veteran will be instructed to view the matrices of faces as he chooses, as described above in the assessment task. The music chosen by the veteran will play only when s/he is looking at neutral faces and it will stop when s/he looks at threatening faces.
干预措施: Gaze-Contingent Feedback Training (Behavioral)
RT-Based Attention Bias Modification
The task consists of 160 trials. Each trial begins with a centrally-presented fixation cross (+), on which the participant is asked to focus for 500ms. When it disappears, two stimuli will be presented 1.5cm above and below the previous fixation cross for 500ms. After the stimuli disappear, a target probe (right- or left-pointing arrowhead) will appear in place of one of the stimuli, and the participant will be asked to indicate which target probe is presented by pressing the respective key. The target probe will remain on the screen until the participant's response, after which a new trial will begin.
Participants are instructed to identify the probe type as quickly and accurately as possible.
In the training task, all of the target probes will appear in the neutral face location. Thus, over multiple trials, learning occurs that the threatening face predicts the location of the target probe, thereby achieving the desiring change in attention patterns.
干预措施: Attention Bias Modification (Behavioral)
Non-Contingent Feedback Training
This condition is based on the aforementioned eye-tracking task with a fundamental change - The music chosen by the veteran will play continuously without any reinforcement for looking at threat or neutral faces.
干预措施: Non-Contingent Feedback Training (Behavioral)
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
- Post-treatment Clinical Global Impression Scale(1-2 weeks post-treatment)
- 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)
研究者
Yair Bar-Haim
Professor
Tel Aviv University