Psychometric Evaluation of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) in an Active Duty and Military Veteran Sample
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 950
- 试验地点
- 3
- 主要终点
- Test-retest reliability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) Total Score
研究概览
简要总结
Given the high prevalence of post-traumatic stress disorder (PTSD) in veterans and active duty military, the focus of this research study is to test the reliability of two new PTSD assessments, the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) and compare the results between the two new assessments and the previous "gold standard", the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV). Biomarkers believed to be related to PTSD (e.g., biofluid biomarkers, cognitive and physiological markers, and neural activity as measured by EEG) will be collected to inform targeted interventions in specific groups of patients and other large-scale biomarker discovery efforts in the field. Participants will be 950 male and female active duty military and veterans ages 18 or older who have been exposed to at least one traumatic event.
详细描述
This is a randomized, observational study where participants will be randomized into one of the four study cohorts. The primary goals of this study are to establish the test-retest reliability of the CAPS-5 and the PSSI-5 and to compare these with each other (Cohorts 1 and 2), to test the convergent validity of the CAPS-5 against the PSSI (Cohort 3) and against the CAPS-IV (Cohort 4), and finally to investigate the consistency of response over 12 weeks on CAPS-5 (Cohort 1) and on the PSSI-5 (Cohort 2). In addition, on an exploratory level, possible biomarkers of PTSD and their relationship to each other and to diagnosis of PTSD will be evaluated.
Participants will be 950 males and females recruited from the Cincinnati VA Medical Center (Cincinnati, OH), Trauma Recovery Center, and Tripler Army Medical Center (Honolulu, HI).
the investigators anticipate that understanding the validity and reliability of the PSSI-5 and the CAPS-5 and the biomarkers related to PTSD will provide necessary information for care provided to active duty military and veterans suffering from PTSD. It will also directly inform trial designs and increase the likelihood of technical and regulatory success for new treatments for PTSD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female active duty personnel or military veterans, 18 years of age or older
- •Competent to give informed consent
- •Have experienced any Criterion A qualifying traumatic event as defined by the Life Events Checklist for DSM-5 (LEC-5)
- •Score a 3 or above on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)
排除标准
- •Current suicidal or homicidal ideation with a plan, and substance use disorder requiring detoxification currently or in the past month as assessed using the SCID and Suicidal Ideation/Homicidal Ideation screening tool (SI/HI screen)
- •Assessment using CAPS or PSSI in the previous 1 year
- •Currently receiving psychotherapy or counseling for PTSD
- •Moderate to sever cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)
- •Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or other psychotic disorders in the last month
结局指标
主要结局
Test-retest reliability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) Total Score
时间窗: 7 days (+/- 2) between measurements
To determine the test-retest reliability of Posttraumatic Stress Disorder Symptom Scale Interview-5 within Visits 2-3 for Groups 1-B and 2-B. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme)
Stability of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) item-level scores over 6 weeks
时间窗: Up to 6 weeks for Group 1-B
Change in the DSM-5 Clinician Administered PTSD Scale item-level scores over 6 weeks. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme)
Stability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) item-level scores over 6 weeks
时间窗: Up to 6 weeks for Group 2-B
Change in PTSD Symptom Scale for DSM-5 Posttraumatic Stress Disorder Symptom Scale Interview item-level scores over 6 weeks. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme)
Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
时间窗: 7 days (+/- 2) between measurements
Concordance of the Clinician Administered PTSD Scale Total Score of at 2 visits. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme)
Correlation among the total scores of the CAPS-5, PSSI-5, and Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)
时间窗: Up to 39 days from the eligibility screen for Cohorts 1-4
Correlation coefficient among the totals scores for 3 different PTSD symptom scales
次要结局
- Concordance rate between diagnostic tests(7 days (+/- 2) between measurements)