Changing the Treatment Course: Clinical Trial of Sequenced Interventions to Optimize Treatment for Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 302
- 试验地点
- 8
- 主要终点
- Posttraumatic Stress Disorder Checklist (PCL-5)
研究概览
简要总结
By doing this research project, the investigators hope to learn which strategies work best to help veterans who are not benefiting from their first PTSD treatment or not completing between-session homework assignments regularly that might improve treatment response. The investigators also want to learn how best to match the right type and amount of treatment to each individual veteran. By conducting this research project, they hope to:
- See if trying a different treatment strategy for veterans not responding to their first PTSD treatment would be more helpful
- See if sending text message prompts between sessions encourages more completion of between-session homework
详细描述
This study is designed to assist the investigators in answering the clinical question of how to address non-response to first line PTSD treatments. Utilizing an innovative Hybrid Experimental Design (HED), the proposed study involves multiple, sequential randomizations to both therapist-delivered and digital interventions operating on short and long timescales to determine the optimal combination and sequencing of evidence-based interventions to maximize response. This will result in actionable data and, consistent with a personalized medicine approach, an implementable, adaptive treatment regimen that optimizes clinical resource allocation. By recruiting and providing treatment in routine care settings serving veterans with PTSD, the study design maximizes generalizability, relevance to the VA mission, and implementation potential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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 eligible for PE and CPT at the participating PTSD treatment-providing clinic who are
- •At least 18 years or older
- •Score ≥ 31 on the PCL-5 secondary to a Criterion A traumatic event
- •Own a mobile device that can be used for the therapy companion mobile app (Prolonged Exposure (PE) coach or Cognitive Processing Therapy (CPT) coach).
排除标准
- •Acute suicide risk requiring clinical intervention
- •Need for detoxification
- •Unmanaged psychosis or bipolar disorder
- •Severe cognitive impairment that makes it unlikely that participants can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
- •Current or past 12-month engagement in PE or CPT.
结局指标
主要结局
Posttraumatic Stress Disorder Checklist (PCL-5)
时间窗: 10 weeks, 20 weeks and 9 months
The PCL-5 is a psychometrically valid measure and commonly used assessment of PTSD symptoms. A total score is calculated by adding up the ratings for each of the 20 items, which range from 0 to 4 (0=Not at all, 4=Extremely). Higher scores reflect more severe symptoms. A score below 31 generally suggests a sub-clinical range, while scores of 31 or above fall within the clinical range, indicating probable PTSD.
次要结局
- Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline, 10-weeks, 20-weeks, 9-months)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, 10-weeks, 20-weeks, 9-months)
- Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)(Baseline, 20-weeks, 9-months)
- Brief Inventory of Psychosocial Functioning (B-IPF)(Baseline, 10-weeks, 20-weeks, 9-months)
研究者
Stefanie LoSavio
Assistant Professor of Psychiatry & Behavioral Sciences
The University of Texas Health Science Center at San Antonio