A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV
研究概览
简要总结
The objective of this protocol is to test the feasibility and acceptability of the Relaxation Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body skills and interventions to decrease medical and mental health symptoms and build resilience, in Spanish-speaking World Trade Center (WTC) survivors, and to examine its clinical effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety, and lower respiratory symptoms (LRS) and improve psychosocial functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •score > or = 44 on the PTSD Checklist PCL, considered the broad definition of PTSD syndrome71
- •report at least one LRS symptoms (i.e., shortness of breath, wheezing, dyspnea or cough).
- •Spanish Speaking
排除标准
- •regular practice of eliciting relaxation response (i.e., meditation, yoga) in the past 6 months,
- •serious unmanaged mental illness including bipolar disorder, psychosis, and active substance misuse disorders;
- •inability to participate in consecutive sessions over 3-month period.
研究组 & 干预措施
Relaxation Response Resiliency Program (3RP)
干预措施: 3 RP (Behavioral)
结局指标
主要结局
Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV
时间窗: 1 Month
State-of-the-art instrument for obtaining psychiatric diagnoses.
Health Promoting Behaviors will be assessed with the Health Promoting Lifestyles Profile-II (HPLP-II)
时间窗: 1 Month
he HPLP-II is a 52 item self-report inventory of health behaviors and has been used in previous mind-body treatment studies
Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)
时间窗: 1 Month
Symptom Severity using PTSD Checklist
时间窗: 1 Month
Symptoms will be assessed with the PTSD Checklist (PCL), a 17-item self-report measure of current (past month) PTSD symptoms based on the DSM-IV criteria. It is a widely-used and validated measure of PTSD symptom severity.
Measure of Functional Impairment using the Range of Impaired Functioning Tool (RIFT)
时间窗: 1 Month
widely-used instrument that taps the domains of work, household duties, interpersonal relationships, recreation, and subjective satisfaction with life. Each domain is rated on a five-point scale from very good to very poor. The total score is the sum of the different domains.
Measure of treatment expectancy using the Treatment Credibility/Expectancy Questionnaire.
时间窗: 1 Month
The 6-item Treatment Credibility/Expectancy Questionnaire (CEQ)84 will be used to examine treatment expectancy related to the 3RP.
Assessment of Mindful attention using Mindful Attention Awareness Scale (MAAS)
时间窗: 1 Month
The MAAS is a 15-item questionnaire on which respondents indicate, on a 6 point Likert-type scale (1 = almost always to 6 = almost never), their level of awareness and attention to present events and experiences.
次要结局
未报告次要终点