跳至主要内容
临床试验/NCT07741201
NCT07741201尚未招募不适用

An Adaptive Psychological Intervention to Improve Pain and Reduce Opioid Use Following an Injury

Henry Ford Health System0 个研究点目标入组 80 人开始时间: 2027年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Opioid use

研究概览

简要总结

The goal of this proposed project is to optimize the adaptive psychological intervention and assess the feasibility and acceptability. The long-term objective of this line of research is to evaluate whether an adaptive psychological intervention delivered after a musculoskeletal injury is effective in preventing the development of chronic pain and long-term opioid use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
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

入选标准

  • Admitted to Henry Ford Hospital
  • Has an acute musculoskeletal injury
  • Prescribed opioids during the admission

排除标准

  • Under age 18
  • Cognitive impairment (i.e., diagnosis of delirium, dementia, or traumatic brain injury/Glasgow Coma Scale less than 13)
  • Chronic pain condition (i.e., pain most of the day, nearly every day for the past 3 months or longer)
  • Taking opioids 30 days or more prior to this hospitalization

研究组 & 干预措施

Subgroup 4

Experimental

Participants who were randomized to the computerized brief intervention and were still on opioids 10 days post-baseline and were then randomized to receive the recommendations for the opioid taper.

干预措施: Computerized brief intervention (Behavioral)

Subgroup 4

Experimental

Participants who were randomized to the computerized brief intervention and were still on opioids 10 days post-baseline and were then randomized to receive the recommendations for the opioid taper.

干预措施: Opioid taper recommendations (Behavioral)

Subgroup 1

No Intervention

Participants who were not randomized to the computerized brief intervention and were no longer on opioids 10 days post-baseline and did not receive any further treatment.

Subgroup 2

Active Comparator

Participants who were not randomized to the computerized brief intervention but were on opioids 10 days post-baseline and received recommendations for an opioid taper.

干预措施: Opioid taper recommendations (Behavioral)

Subgroup 3

Experimental

Participants who were randomized to the computerized brief intervention but were no longer on opioids 10 days post-baseline and did not receive any further treatment.

干预措施: Computerized brief intervention (Behavioral)

Subgroup 5

Experimental

Participants who were randomized to the computerized brief intervention and were still on opioids 10 days post-baseline and were then randomized to receive the recommendations for the opioid taper plus additional psychological treatment sessions.

干预措施: Computerized brief intervention (Behavioral)

Subgroup 5

Experimental

Participants who were randomized to the computerized brief intervention and were still on opioids 10 days post-baseline and were then randomized to receive the recommendations for the opioid taper plus additional psychological treatment sessions.

干预措施: Psychological sessions (Behavioral)

Subgroup 5

Experimental

Participants who were randomized to the computerized brief intervention and were still on opioids 10 days post-baseline and were then randomized to receive the recommendations for the opioid taper plus additional psychological treatment sessions.

干预措施: Opioid taper recommendations (Behavioral)

结局指标

主要结局

Opioid use

时间窗: 90-day follow-up

Whether patient was using opioids

次要结局

  • Morphine Dose Equivalent (MDE)(90-day follow-up)
  • Presence of chronic pain(90-day follow-up)
  • Pain severity(90-day follow-up)
  • Pain interference(90-day follow-up)
  • Mindfulness(90-day follow-up)
  • Pain acceptance(90-day follow-up)
  • Depression(90-day follow-up)
  • Anxiety(90-day follow-up)
  • Sleep(90-day follow-up)
  • Impact of Events Scale Revised(90-day follow-up)
  • Opioid misuse(90-day follow-up)

研究者

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

Lisa Matero

Associate Scientist

Henry Ford Health System

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