Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Guilt
研究概览
简要总结
A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event.
详细描述
A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event. The investigators expect that this intervention will lead to improvement in posttraumatic guilt, shame, and PTSD symptoms as compared to an active control condition.
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 (Participant)
盲法说明
The participant will be randomly assigned to the active or control condition. The participant will not be informed of which condition they are receiving until after completion of the study, at which point individuals in the control condition will be given access to the active intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Endorsed prior TI experience (TIQ items A & B)
- •Elevated posttraumatic stress symptoms (PCL-5; Blevins et al., 2015)
排除标准
- •Inability to consent or complete the intervention including:
- •Cognitive impairment
- •Uncorrected visual or auditory impairment
- •Unmedicated severe mental illness
- •Imminent risk of harm to self or others
结局指标
主要结局
Guilt
时间窗: post-intervention, on Day 1
Feelings of guilt as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes.
Shame
时间窗: post-intervention, on Day 1
Feelings of shame as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes.
Posttraumatic Stress Disorder Symptoms
时间窗: up to 1 month
PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item scale with values ranging from 0 to 4 for each item. Items are totaled for a total score ranging 0 to 80, with lower values indicating better outcomes.
次要结局
未报告次要终点
研究者
Norman Schmidt
Distinguished Research Professor
Florida State University