Fading Safety Behaviors in an Internet-Based Secondary Prevention for Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Posttraumatic Cognitions Inventory (PTCI)
研究概览
简要总结
Research on decreasing safety behaviors in therapy has been restricted to treatments for other anxiety disorders and has not included PTSD. In order to address this gap and to develop a widely accessible, cost-effective prevention, an internet-based, three-arm randomized secondary PTSD prevention trial is proposed. Self-help psychoeducation on common reactions to trauma and eliminating safety behaviors will be employed for participants who have recently experienced a traumatic event. Participants will be randomized to receive (a) psychoeducation on trauma symptoms only, (b) combined psychoeducation on trauma symptoms and eliminating safety behaviors, or (c) monitoring only control. All participants will monitor safety behaviors and trauma symptoms weekly for eight weeks. Psychoeducation materials will be handouts and videos administered online via REDCap.
It is hypothesized that participants in both psychoeducation conditions will have a lower incidence of PTSD, threat appraisal, and safety behaviors than participants in the monitoring-only control. It is also hypothesized that participants who receive combined psychoeducation on trauma symptoms and fading safety behaviors will have a lower incidence of PTSD, threat appraisal, and safety behaviors at Weeks 4 and 8 than will participants who receive psychoeducation on trauma symptoms only or participants in the monitoring-only control. It is further hypothesized that the effects of combined psychoeducation on preventing PTSD and threat appraisal will be mediated by decreased use of safety behaviors. Finally, it is hypothesized that combined psychoeducation on trauma symptoms and fading safety behaviors will be more effective in preventing PTSD for participants with higher levels of safety behaviors or threat appraisal at baseline. If effective, this secondary prevention program could be distributed widely to people who have recently experienced a trauma to prevent their development of PTSD.
详细描述
Baseline Assessment Participants will first access the study online through web links posted to widely accessible websites such as Facebook, Reddit, and Craigslist, and through The University of Texas at Austin PSY 301 SONA pool. Participants will also be recruited through Amazon Mechanical Turk. Participants will provide informed consent and will complete eligibility criteria, which will take approximately 5 minutes. Participants who meet eligibility criteria will immediately complete a baseline assessment, which will take approximately 25 minutes, including a basic demographics questionnaire and a thorough assessment of psychopathology symptoms and safety behaviors.
Randomization Immediately after baseline assessment, each participant will be automatically randomized into one of three study conditions. Randomization will be stratified based on number and severity of safety behaviors used and level of Acute Stress Disorder symptoms reported at baseline. Once randomized, participants in the two psychoeducation conditions will immediately receive psychoeducation materials, and all participants will receive rationale for their study condition, as specified below. All three conditions will complete the same schedule of assessments.
Conditions
Condition 1: Psychoeducation on trauma symptoms (PSYED-T) In Condition 1, participants will receive view a psychoeducation handout and video on trauma symptoms. Participants in this condition will also receive a rationale stating that learning about the nature of trauma reactions as well as monitoring trauma reactions and safety behaviors are important for preventing development of PTSD.
Condition 2: Combined psychoeducation on trauma symptoms and fading safety behaviors (PSYED-T+SB) Participants in Condition 2 will receive view a psychoeducation handout and video on trauma symptoms and on safety behaviors and how to fade them. Participants in this condition will also receive a rationale stating that learning about the nature of trauma reactions, learning to eliminate safety behaviors, and monitoring trauma reactions and safety behaviors are important in the prevention of PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will be told of the specifications only of the condition to which they are assigned.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English
- •Have regular access to the internet and email for eight weeks
- •Have experienced a Criterion A trauma within the past 30 days, as assessed by the Life Events Checklist for DSM-5 (LEC-5; Weathers et al., 2013a)
排除标准
- •Psychotic symptoms within the past six months, as measured by Psychiatric Diagnostic Screening Questionnaire (PDSQ) psychosis subscale
- •Current suicidal intent, as measured by Beck Depression Inventory (BDI-II) suicidality item
- •Immediate risk to others
- •Have experienced a traumatic brain injury or other serious neurocognitive impairment in the past six months.
- •Prior history of PTSD
结局指标
主要结局
Posttraumatic Cognitions Inventory (PTCI)
时间窗: Weekly change between baseline and Week 8
Level of threat appraisal will be measured by the Posttraumatic Cognitions Inventory (PTCI).
PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5)
时间窗: Week 8
PTSD diagnosis at Week 8 will be measured by the PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5).
PTSD Symptom Scale Interview for DSM-5 (PSSI-5)
时间窗: Week 8
PTSD diagnosis at Week 8 will be measured by the PTSD Symptom Scale Interview for DSM-5 (PSSI-5). Only participants who meet criteria for PTSD based on the PSS-SR-5 will be assessed.
PTSD Safety Behavior Inventory (PSBI)
时间窗: Weekly change between baseline and Week 8
The number of safety behaviors used will be measured by the PTSD Safety Behavior Inventory (PSBI).
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Weekly change between baseline and Week 8
Level of PTSD symptoms will be measured by the PTSD Checklist for DSM-5 (PCL-5).
次要结局
- National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS-ASD).(Week 0)
- Credibility and Expectancy Questionnaire (CEQ)(Week 0)
- Anxiety Sensitivity Index (ASI-3)(Week 0, Week 4, Week 8)
- Patient Health Questionnaire-9 (PHQ-9)(Weekly change between baseline and Week 8)
- Generalized Anxiety Disorder 7-item scale (GAD-7)(Weekly change between baseline and Week 8)
- Life Events Checklist for DSM-5 (LEC-5)(Week 0)
- Peritraumatic Dissociative Experiences Questionnaire (PDEQ)(Week 0)
- Alcohol Use Disorders Identification Test - Short Version (AUDIT-C)(Weekly change between baseline and Week 8)
- Acute Stress Disorder Scale (ASDS)(Week 0)
- Trauma Coping Self-Efficacy scale (CSE-T)(Weekly change between baseline and Week 8)
- Beck Depression Inventory (BDI-II)(Week 0, Week 4, Week 8)
研究者
Michael J. Telch
Professor
University of Texas at Austin