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临床试验/NCT04021030
NCT04021030已完成不适用

Building Collaborations to Address Drug Problems in the United States and China

University of Michigan1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Proportion of participants with decrease in pain level ≥ 18 % (or two points) on the Numeric Rating Scale (NRS)

研究概览

简要总结

The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT) intervention on the distribution and variability of pain level before and after intervention receipt among people with co-occurring chronic pain and Substance Use Disorders (SUDs) over a three-month follow-up period.

详细描述

The project is an open trial of the CBT intervention for 20 adults receiving detoxification treatment with comorbid pain. Participants will be screened for pain and other conditions by completing a self-report survey questionnaire. Eligible participants will be asked to complete a baseline assessment. A trained research therapist will conduct individual therapy with participants twice a week for 2-4 weeks. Participants will be re-assessed at 1- and 3-month post-intervention follow-ups to track changes in their pain, functioning, and substance use.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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
否

入选标准

  • •At least 18 years of age
  • •Currently receiving detoxification treatment
  • •Report pain of at least moderate or greater intensity over the three months prior to baseline assessment as indicated by an average score of four or greater on the Numeric Rating Scale (NRS)
  • •Have access to a phone for confidential personal therapy after the completion of detoxification treatment. For individuals who enter the residential treatment at the facility following the detoxification treatment, a research therapist will meet with them in person at a private office at the facility during their stay due to program's restriction on phone usage.

排除标准

  • •Inability to speak and understand English
  • •Inability to give informed, voluntary, written consent

研究组 & 干预措施

Cognitive Behavioral Therapy (CBT)

Experimental

干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)

结局指标

主要结局

Proportion of participants with decrease in pain level ≥ 18 % (or two points) on the Numeric Rating Scale (NRS)

时间窗: 3 months post-intervention

Pain level will be assessed using the Numeric Rating Scale (NRS). The NRS is a 0-10 scale, with higher scores indicating greater intensity of pain.

次要结局

未报告次要终点

研究者

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

Mark A. Ilgen

Professor of Psychiatry

University of Michigan

研究点 (1)

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