Chronic Pelvic Pain and Education Skills Training for Women Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Acceptability of intervention
研究概览
简要总结
Chronic pelvic pain (CPP) is a debilitating condition that disproportionately affects women Veterans (25% vs. 16% of civilian women). Predisposing factors include higher rates of strenuous physical activity during military service, duty-related injuries, psychiatric distress, and sexual trauma. CPP is associated with a high burden of illness, disability, and economic costs (estimated at $5.8 billion in annual health care expenditures).
Multimodal, interdisciplinary approaches are emphasized in the treatment of CPP. Psychological interventions are essential for optimizing pain self-management for CPP. Psychosocial factors are known to affect pain intensity and recovery. Women Veterans report higher rates of depression and anxiety with CPP, that leads to greater disability and poorer quality of life. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are effective options for pain self-management. Barriers to effective pain treatment are high attrition and non-adherence. Additionally, women Veterans prefer treatments that address their gender-specific needs. Gender-specific services remain limited in the Veterans Health Administration (VHA).
In line with VHA's priorities to expand women's health care, this study implements ACT in a brief intervention format to address a highly prevalent reproductive health issue among women Veterans. ACT is transdiagnostic and thus provides a unified approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Brief workshop formats increase treatment completion and patient engagement. This study seeks to adapt an existing 1-day ACT workshop for use in VHA integrated primary care (PCMHI) and specialty medical settings with women veterans experiencing CPP. Primary outcomes are feasibility and acceptability of the adapted 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being a Veteran
- •Being female
- •Having a diagnosis of chronic pelvic pain
- •Endorsing severe pain (score ≤ 7 on Brief Pain Inventory [BPI]) or moderate to severe pain plus clinically significant psychological distress (score ≤ 3 on BPI and score ≤ 10 on Patient Health Questionnaire-9 [PHQ-9] or Generalized Anxiety Disorder-7 [GAD-7])
排除标准
- •Cognitive impairment
- •An uncontrolled bipolar or psychotic diagnosis
- •Active suicidal ideation
- •Receiving concurrent psychotherapy or who have received ACT within the past year
结局指标
主要结局
Acceptability of intervention
时间窗: 2-month follow-up
Open-ended question about how satisfactory veterans find the intervention (including likes, dislikes, and recommendations for improving the intervention)
Feasibility of recruitment
时间窗: Up to 1 year
Recruitment rates (number enrolled/number who complete treatment)
次要结局
- Mean change score in McGill Pain Questionnaire(Change at 2-month follow-up from baseline)
- Mean change score in Patient Health Questionnaire (PHQ-9)(Change at 2-month follow-up from baseline)
- Mean change score in Generalized Anxiety Disorder Scale (GAD-7)(Change at 2-month follow-up from baseline)
- Mean change in Short Form Veteran Health Survey (VR-12)(Change at 2-month follow-up from baseline)
研究者
Derrecka Boykin
Assistant Professor
Baylor College of Medicine
