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临床试验/NCT06481501
NCT06481501暂停不适用

Mindfulness Intervention for Individuals With HIV and Chronic Pain

Florida State University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
40
试验地点
2
主要终点
Intervention Adherence

研究概览

简要总结

This project is a single-site, two-arm, randomized controlled pilot study examining the impact of a 2-hour version of Mindfulness-Oriented Recovery Enhancement (ONE MORE) training for individuals with HIV and chronic pain.

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

  • Diagnosis of chronic pain
  • 18 years of age or older
  • Fluent English speaker
  • Will commit to try no other new treatments during study duration

排除标准

  • Not having HIV
  • Being unable to follow tasks due to pain level
  • Prior mindfulness training

研究组 & 干预措施

ONE Mindfulness-Oriented Recovery Enhancement

Experimental

One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into four, 30-minute segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Mindful pain management will be the focus of the second segment and participants will be guided through a mindfulness of pain practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The third segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, and the fourth segment will focus on increasing the positive emotions that can attenuate pain with mindful savoring.

干预措施: ONE Mindfulness-Oriented Recovery Enhancement (Behavioral)

Treatment As Usual

No Intervention

In the Treatment as Usual (TAU) condition, participants will complete all study assessments (pre-treatment, post-treatment, 2-week, 4-week) without receiving any ONE MORE training. During their study involvement, TAU participants will be encouraged to continue any previously initiated treatment but discouraged from beginning any new form of treatment. Those in the TAU condition will not be sent any training materials.

结局指标

主要结局

Intervention Adherence

时间窗: 2 Hours

Examine the percentage of participants completing their 2-hour intervention session.

Recruitment Feasibility

时间窗: 4 months

Examine recruitment rates during the 4 months of recruitment.

Treatment Acceptability

时间窗: Completed immediately after the 2-hour ONE MORE training

Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Higher scores reflect greater acceptability.

次要结局

  • Global Impression of Change(Completed at 2- and 4-week follow-ups)

研究者

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

Adam Hanley

Principal Investigator

Florida State University

研究点 (2)

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