An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Hospital Administrative Data Showing 2 Mental Health Visits Completed
研究概览
简要总结
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project seeks to improve health care for Veterans by testing the effectiveness of a primary care-based treatment called clinician-supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. If this treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.
详细描述
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project represents a unique opportunity to improve health care for Veterans by examining the effectiveness of a primary care-based treatment called Clinician-Supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. This randomized clinical trial will enroll and treat 260 VA primary care patients (female and male) who have PTSD and are not currently being treated for it. Commonly used, well-established clinical interviews and self-report measures will be used to assess important clinical outcomes. If this direct treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The CAPS-5 will be administered via phone by a central assessor, blind to condition, at baseline and post-treatment and will be the primary measure of change in PTSD symptom severity.
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 enrolled in primary care within the VA Syracuse and Palo Alto healthcare systems reporting 33 on the PTSD Checklist-5 (PCL-5) and a traumatic event on the Criterion A screener
排除标准
- •Patients will be excluded if they demonstrate symptoms that would not allow them to actively engage in the CS PTSD Coach, i.e.,
- •gross cognitive impairment
- •Current symptoms of mania or psychosis or who have more pressing concerns that need to be addressed first, i.e.,
- •suicide attempt in the last two months or current intent to commit suicide
- •Patients with recent suicide attempts or intent are eligible to be enrolled follow the receipt of suicide prevention services
- •The investigators will also exclude patients that are already receiving psychotherapy or MH counseling for PTSD outside of PC
- •Started or changed the dose of a psychotropic medication for PTSD in the last two months that was prescribed outside of VA PC
- •Voice a preference to be directly referred to MH specialty care
研究组 & 干预措施
Clinician-Supported PTSD Coach
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
干预措施: Clinician-Supported PTSD Coach (Behavioral)
Primary Care Mental Health Integrated Care as Usual
Existing primary care mental health integrated treatment will serve as the comparison condition
干预措施: Primary Care Mental Health Integrated Care as Usual (Behavioral)
结局指标
主要结局
Hospital Administrative Data Showing 2 Mental Health Visits Completed
时间窗: 16 and 24 weeks
Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic during the follow-up period.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Baseline
The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.
次要结局
- Patient Health Questionnaire (PHQ-9)(Baseline, 8 week, 16 week, 24 week)
- WHOQOL-BREF Social Relationships Subscale(Baseline, 8 week, 16 week, 24 week)
- PTSD Checklist-5 (PCL-5)(Baseline, 8 week, 16 week, 24 week)
- Client Satisfaction Questionnaire (CSQ)(8 week)
- WHOQOL-BREF Psychological Health Subscale(Baseline, 8 week, 16 week, 24 week)