Examination of a Safety Aid Reduction Protocol for Treatment Resistant PTSD Among Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in PTSD diagnostic status as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
研究概览
简要总结
The purpose of this project is to examine the efficacy of a safety aid reduction treatment (START), compared to a wait-list control, among Veterans with posttraumatic stress disorder (PTSD). It is hypothesized that participation in START, compared to a wait-list control, will be associated with decreased PTSD symptom severity immediately and over time.
详细描述
Rates of posttraumatic stress disorder (PTSD) among military personnel have surged in recent years. In response, the Department of Veterans Affairs (VA) has launched nationwide training initiatives to disseminate two PTSD treatments with strong empirical support: prolonged exposure (PE) therapy and cognitive processing therapy (CPT). Despite the well-documented effectiveness of PE and CPT, only a minority of Veterans with PTSD initiate these trauma-focused treatments. One approach to addressing PTSD in a non-trauma-focused fashion is to utilize empirically supported treatments focused on safety aid reduction. Safety aids are maladaptive cognitive and/or behavioral strategies designed to prevent, avoid, or alleviate anxiety. Initially introduced as a way to explain how pathological anxiety can persist despite repeated exposure to feared stimuli, safety aids have been found to play a critical role in the etiology and maintenance of various anxiety and related conditions including PTSD. Importantly, a separate line of research suggests that safety aids are amenable to change through cognitive behavioral interventions. Although promising, these trials did not include patients with PTSD. In this context, the purpose of this project is to examine the efficacy of a safety aid reduction treatment (START), compared to a wait-list control. Participants will include veterans with a diagnosis of PTSD who decline to participate in evidence-based psychotherapies (EBPs) for PTSD, namely PE or CPT. It is hypothesized that participation in START, compared to a wait-list control, will be associated with decreased PTSD symptom severity immediately and over time.
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 (Outcomes Assessor)
盲法说明
Outcome assessments will be conducted by a member of the study team who is blind to veteran treatment condition.
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
- •Veterans receiving care at New Orleans VA
- •Veterans with diagnosis of PTSD who decline trauma focused treatment
排除标准
- •Substance dependence requiring detoxification
- •Active psychosis
- •Uncontrolled Bipolar Disorder
- •Severe suicidal intent requiring hospitalization
- •Current engagement in psychotherapy
结局指标
主要结局
Change in PTSD diagnostic status as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Baseline and one-month follow-up
The CAPS-5 is a 30-item clinician-administered interview designed to assess current (i.e., past month) and lifetime PTSD diagnostic status. In addition to assessing the 20 DSM-5 PTSD symptoms, the CAPS-5 contains questions regarding the onset and duration of symptoms, associated impairment in various life domains, and specifications for the dissociative subtype. The past month CAPS-5 will be administered at baseline and one-month follow-up to assess changes in PTSD diagnostic status.
Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
时间窗: Baseline, post-intervention (10-weeks), and one-month follow-up
The PCL-5 is a 20-item self-report questionnaire designed to assess each of the 20 DSM-5 PTSD symptoms. Veterans will be asked to read a list of symptoms and indicate their level of distress as it relates to each within the past month using a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (Extremely) with higher scores reflecting increased symptom severity. The PCL-5 will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in PTSD symptom severity.
Changes in safety aid usage as measured by the Safety Behavior Assessment Form (SBAF)
时间窗: Baseline, post-intervention (10-weeks), and one-month follow-up
The SBAF is a 41-item self-report questionnaire designed to assess safety behavior usage. Veterans will be asked to read a list of behaviors and rate how often they engage in each behavior using a 4-point Likert-type scale ranging from 0 (Never) to 3 (Always) with higher scores reflecting increased symptom severity. The SBAF will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in safety behavior usage.
Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: Post-intervention (10-weeks)
The CSQ-8 is an 8-item self-report questionnaire designed to assess overall satisfaction with treatment services. Although response options differ from item-to-item, all questions are rated on a 4-point Likert-type scale ranging from 1 to 4 with higher scores indicating higher treatment satisfaction. The CSQ-8 will be administered immediately following the 10-week group to assess treatment acceptability.
次要结局
- Changes in anxiety as measured by the Beck Anxiety Inventory (BAI)(Baseline, post-intervention (10-weeks), and one-month follow-up)
- Changes in depression as measured by the Beck Depression Inventory-II (BDI-II)(Baseline, post-intervention (10-weeks), and one-month follow-up)
- Changes in PTSD cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)(Baseline, post-intervention (10-weeks), and one-month follow-up)
- Changes in funtional impairment as measured by the Sheehan Disability Scale (SDS)(Baseline, post-intervention (10-weeks), and one-month follow-up)