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临床试验/NCT03692468
NCT03692468已完成不适用

A Brief Intervention for Co-occurring Pain and Distress in Primary Care

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2018年9月20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
61
试验地点
2
主要终点
Hospital Anxiety and Depression Scale

研究概览

简要总结

The purpose of this research study is to investigate potential benefits of a behavioral intervention for co-occurring chronic pain and distress that is delivered in a primary care clinic.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic pain condition
  • A current patient within the Henry Ford Health System Academic Internal Medicine Clinic in Detroit
  • Has been within the Henry Ford Health System for at least 6 months

排除标准

  • Current behavioral health treatment

结局指标

主要结局

Hospital Anxiety and Depression Scale

时间窗: 5 weeks post-baseline

This measure assesses the severity of depression and anxiety. Scores on each of the subscale (e.g., depression and anxiety) range from 0-21 with higher scores indicating greater severity.

Brief Pain Inventory

时间窗: 5 weeks post-baseline

The Brief Pain Inventory measures pain severity and pain functioning. Pain severity is comprised of 4 questions on a 0-10 scale for pain at it's worst in the past week, the least in the past week, on average, and then currently. Each item is scored separately and higher scores indicate greater pain severity. There are then 12 daily activities in which the participants rates on a scale of 0-10 regarding how much the pain interferes with the activity (10 being the highest interference). These are all scored separately.

次要结局

  • Satisfaction with Life Scale(Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups)
  • Health care utilization(Measured 6 months before and 6 months after study enrollment)
  • Pain Catastrophizing Scale(Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups)
  • Insomnia Severity Index(Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups)

研究者

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

Lisa Matero

Senior Staff Psychologist

Henry Ford Health System

研究点 (2)

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