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临床试验/NCT03495856
NCT03495856已完成不适用

Feasibility of a 4-week, Adapted Mindfulness Program for Adults With Chronic Pain

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年4月23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
23
试验地点
1
主要终点
Credibility and Expectancy Questionnaire Scores

研究概览

简要总结

The objective of this study is to determine the feasibility and acceptability of a 4-week mindfulness training program for adults with chronic pain (noncancer related). The intervention is based on the MIndfulness-based Stress Reduction Program, an 8-week mindfulness training program developed to help people manage stress-related and chronic conditions. The adapted mindfulness intervention will consist of four, weekly 1 hour and 30 minute group sessions that are modified from the original program to fit the shorter length and to directly address chronic pain management. Participants will complete pre- and post-intervention surveys and daily mindfulness practice diaries, all online. The surveys will help us determine if participants experience decreased pain interference, increased quality-of-life, and increased psychological well-being over the course of the intervention. Participants will also complete a post-intervention telephone interview to help determine satisfaction with the intervention and areas where the intervention can be improved.

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

  • •One or more chronic noncancer pain diagnoses (daily pain for at least 3 months)
  • •Has a pain management provider
  • •Reports more than minimal pain bothersomeness and interference in general activities
  • •Able to read and understand English

排除标准

  • •Diagnosis of mental illness with psychotic features
  • •History of inpatient admission for psychiatric disorder in past 2 years
  • •Active alcohol or substance abuse within the past year
  • •Has completed a mindfulness-based stress reduction or other mindfulness course; has or previously had a regular mindfulness meditation practice.
  • •Unable or unwilling to comply with study procedures (online questionnaires and practice diaries, 4 weekly intervention sessions, home practice, and one semi-structured phone interview).

研究组 & 干预措施

Mindfulness Training For Chronic Pain

Experimental

The intervention is adapted from the mindfulness-based stress reduction program. The adapted mindfulness training program consists of four, weekly 90 minute group sessions that focus on education on chronic pain and mindfulness, instruction and in-class mindfulness skills practice, and group discussion.

干预措施: Mindfulness Training For Chronic Pain (Behavioral)

结局指标

主要结局

Credibility and Expectancy Questionnaire Scores

时间窗: Intervention week 2

Credibility and Expectancy Questionnaire. Each item is scored separately and rated on a scale from 1 \[not at all\] to 10 \[very\]. Scores for each item range from 1-10, with higher ratings indicating higher credibility and expectancy.

Feasibility - Session Attendance

时间窗: 4 weeks (intervention weeks 1-4)

Average sessions attended (proportion)

Feasibility - Study Retention

时间窗: 4 weeks

Proportion of participants enrolled who completed the study

Acceptability - Intervention Satisfaction

时间窗: 4 weeks (within one week post-intervention)

Question assessing participants satisfaction with the intervention

次要结局

  • Pain Intensity Scores(Baseline and 4 weeks (pre to post-intervention))
  • Depression Short-Form 4a Scores(Baseline and 4 weeks (pre to post-intervention))
  • Pain Interference Scores(Baseline and 4 weeks (pre to post-intervention))
  • Physical Functioning Scores(Baseline and 4 weeks (pre to post-intervention))
  • Anxiety Short-Form 4a Scores(Baseline and 4 weeks (pre to post-intervention))
  • Sleep Disturbance Short-Form 4a Scores(Baseline and 4 weeks (pre to post-intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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