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临床试验/NCT05368155
NCT05368155已完成不适用

Chronic Pelvic Pain and Education Skills Training for Women Veterans

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年9月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Derrecka Boykin

Assistant Professor

Baylor College of Medicine

研究点 (2)

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