Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE): A Controlled Clinical Trial as an Intervention for Chronic Pain From a Homeostatic Perspective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales
研究概览
简要总结
The purpose of this study is to assess the efficacy of a resilience intervention in Veterans with chronic pain compared to wait list control.
详细描述
After being consented and screened for eligibility, participants completed baseline assessments and then were randomized to either the study intervention or wait list control. Participants who were randomized to the study intervention completed post testing assessment measures within two weeks of the final treatment. Participants who were randomized to waitlist conditions completed post testing assessment measures within 2 weeks of the end of the waitlist condition and then subsequently received the study intervention.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18-80 years of age
- •United States Veterans from the conflicts of OEF/OIF to Vietnam era
- •Self-identified chronic pain or chart diagnosis of chronic pain
排除标准
- •Active suicidality of suicidal intent requiring a greater than outpatient level of care (Columbia Suicidality Rating Scale screen, C-SSRS)
- •Active alcohol abuse (Alcohol Use Disorder Identification Test, AUDIT-C)
- •Active psychosis (Psychosis Screener)
- •Current severe disabling illness
- •Inability to participate in a small group interactive setting
- •Inability to meet attendance requirement
- •Neurocognitive conditions other than TBI (e.g. dementia, Parkinsons, stroke)
- •Concurrently receiving Exposure Therapy, Cognitive Behavior Therapy, Acceptance and Commitment Therapy
结局指标
主要结局
RAND 36-item Health Survey (SF-36) - Mental Health and Physical Health subscales
时间窗: 2 weeks
assessment of positive emotional health
PTSD Check List-5
时间窗: 2 weeks
assessment of PTSD symptoms
Insomnia Severity Index
时间窗: 2 weeks
assessment of insomnia symptoms
Pain Catastrophizing Scale
时间窗: 2 weeks
assessment of pain catastrophizing symptoms
Neuropsychological Assessment Battery (NAB) - Word Generation subtest
时间窗: 2 weeks
neuropsychological assessment of executive functions
Patient Health Questionnaire, Depression Scale (PHQ-9)
时间窗: 2 weeks
assessment of depression symptoms
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: 2 weeks
neuropsychological assessment of working memory, episodic memory, and complex attention
Generalized Anxiety Disorder (GAD-7)
时间窗: 2 weeks
assessment of anxiety symptoms
Delis-Kaplan Executive Function System (D-KEFS) - Category Fluency, Category Switching, and Color-Word Switching subtests
时间窗: 2 weeks
neuropsychological assessement
Physical Symptoms Scale (PHQ-15)
时间窗: 2 weeks
assessment of physical symptoms
West Haven-Yale Multidimensional Pain Inventory (WYMPI)
时间窗: 2 weeks
multidimensional assessment of pain
Pain Outcomes Questionnaire (POQ)
时间窗: 2 weeks
multidimensional assessment of pain
次要结局
未报告次要终点
研究者
Aram Mardian
Senior Research Scientist
Phoenix VA Health Care System