A Novel Digital Cognitive Intervention Targeting Intrusive Memories Among Trauma-Exposed Individuals: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Number of Intrusive Traumatic Memories
研究概览
简要总结
Intrusive traumatic memories frequently trigger severe distress and psychological disorders such as post-traumatic stress disorder (PTSD). Traditional therapies require explicit trauma recall, which often causes severe patient distress and may lead to treatment avoidance. To address this, our study introduces a less aversive intervention that combines unconscious visual processing with bilateral eye movements to reduce intrusive traumatic memories. Utilizing a randomized, three-arm design, we will compare standardized trauma-related images, patient-provided images, and neutral images, all paired with bilateral eye movements. We plan to recruit participants who have experienced severe trauma and report at least 5 intrusive memories per week, with a target final sample of 40 participants per arm. The primary outcome is the frequency of intrusive memories. Secondary and additional outcomes include PTSD severity, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), the PTSD Checklist for DSM-5 (PCL-5), and the Impact of Event Scale (IES), as well as depression, anxiety, borderline symptoms, functional improvement, subjective intervention distress, and dropout rates.
详细描述
This study will be conducted on an online platform, which will be used for data collection, task management, and recording of experimental results.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Criterion A for post-traumatic stress disorder (PTSD), which requires exposure to an event involving serious injury or a threat to one's own or another person's physical well-being, either through direct experience or witnessing.
- •Exhibit symptoms from at least three of the five core PTSD symptom domains outlined in DSM-5: intrusive memories (Criterion B), persistent avoidance of trauma-related stimuli (Criterion C), negative alterations in cognitions and mood (Criterion D), alterations in arousal and reactivity (Criterion E), and symptoms lasting for at least one month (Criterion F).
- •Have a total score of 33 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
- •Have internet access and access to a personal computer.
- •Have not taken part in a previous study of this intervention conducted by this research team.
排除标准
- •Fewer than 5 intrusive memories during the baseline week (Week 0).
- •An intelligence quotient (IQ) score lower than
- •A current diagnosis of schizophrenia, obsessive-compulsive disorder (OCD), a severe personality disorder judged to interfere with treatment adherence, or acute suicidal behavior.
- •Severe substance dependence.
研究组 & 干预措施
Pre-selected Phase-scrambled Images with Eye Movement
Participants assigned to this arm receive the same eye-movement intervention with 8 pre-selectedphase-scrambled images that do not contain identifiable trauma-related semantic content. Thisarm is included to control for the general effects of visual stimulation and eye movements whileminimizing trauma-related cue activation.
干预措施: Neutral Images with Eye Movement (Behavioral)
Pre-selected Trauma-related Cue Images with Eye Movement
Participants assigned to this arm receive the eye-movement intervention with a pre-selected set oftrauma-related cue images prepared by the research team.
干预措施: Pre-selected Trauma-related Cue Images with Eye Movement (Behavioral)
Patient-provided Trauma-related Cue Images with Eye Movement
Participants assigned to this arm receive the eye-movement intervention with 4 personalizedtrauma-related cue images that they provided themselves. This arm serves as a high-specificityanchor condition for evaluating treatment effect magnitude, dropout, and acceptability.
干预措施: Patient-provided Trauma-related Cue Images with Eye Movement (Behavioral)
结局指标
主要结局
Number of Intrusive Traumatic Memories
时间窗: Day 66 - 72 (all arms) controlling for baseline week
The number of intrusive memories related to the traumatic event, as recorded by participants in a online diary.
次要结局
- Number of Intrusive Traumatic Memories(Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week)
- Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
- Impact of Event Scale-Revised (IES-R)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
- Beck Depression Inventory-II (BDI-II)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
- State-Trait Anxiety Inventory - State Anxiety (STAI-S)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
- Number of Intrusive Traumatic Memories(Day 1-7 (all arms) before intervention)
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)(Baseline (day 0) and day 73 (all arms))
- Intrusive memory ratings(Day 24, day 48, day 72, 2 months after the last intervention(all arms))
- Post-Intervention Questionnaire(Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms))
- Work and Social Adjustment Scale (WSAS)(Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms))
- Borderline Symptom List 23 (BSL-23)(Baseline (day 0) and day 73 (all arms))
研究者
Zhu Zijian
Associate Professor
Shaanxi Normal University