Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and acceptability of a 6-week app-guided Mindfulness meditation training (MM) intervention and health education (active control) condition in people with spinal cord injury (SCI) who have chronic pain and to examine the feasibility of data collection procedures
详细描述
Our multidisciplinary, interinstitutional team of investigators proposes to randomize 60 SCI patients experiencing chronic pain to practice audio-guided MM for ≥ 10 minutes daily for 6 weeks using the free app "Mindfulness Coach" developed by the Department of Veteran Affairs, or to listen or view health education presentations (active control) ≥ 10 minutes daily for 6 weeks on the free TED app (active control). Primary outcomes are the feasibility and acceptability of proposed interventions in people with SCI and chronic pain. Secondary outcomes include the feasibility of collecting patient-reported outcomes of pain, anxiety, depression, mindfulness, quality of life, stress, fatigue and sleep disturbance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
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
- •Traumatic SCI of at least 6 months duration
- •Chronic pain [defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale]
- •Understand spoken and written English sufficiently to provide informed consent
- •participate in the intervention and complete study surveys
排除标准
- •Lack of daily access to the internet using a smart phone or smart tablet
- •Cognitive impairment (determined by their inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions pertaining to the study)
- •Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations or health education presentations on Ted-talk
- •Use of any kind of meditation more than once a week in the last 3 months
- •Inability to provide or obtain an email address for communication with study staff
- •Inability to operate the app download or study related survey using a smartphone.
结局指标
主要结局
Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent
时间窗: end of study at 3 years
Feasibility as Assessed by the Number of Participants Who Complete the Minimum Recommended Minutes (i.e., 60 Minutes/Per Week) of Using the MM or HE App During the 6 Weeks Intervention
时间窗: post-intervention (6 weeks post-enrollment)
Feasibility as Assessed by the Number of Participants That Complete All Visits
时间窗: post-intervention (6 weeks post-enrollment)
Number of participants that complete all visits defined as participants who completed all study assessments, including baseline visits and immediate post-intervention assessments.
Acceptability Rate as Assessed by the Number of Participants Who Scored 20 or Greater on the Modified Client Satisfaction Questionnaire-8
时间窗: post-intervention (6 weeks post-enrollment)
The Client Satisfaction Questionnaire-8 measures satisfaction and the total score ranges from 8 to 32. The greater the score the higher satisfaction.
次要结局
- Feasibility of Collecting Patient Reported Outcomes of Pain as Assessed by the Number of Participants Who Completed the International SCI Pain Basic Data Subset (Version 2)(post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment))
- Feasibility of Collecting Patient Reported Outcomes of Pain-related Distress as Assessed by the Number of Participants Who Completed the Chronic Pain Acceptance Questionnaire (CPAQ-R8)(post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment))
- Feasibility of Collecting Patient Reported Outcomes of Brief Pain as Assessed by the Number of Participants Who Completed the Brief Pain Catastrophizing Scale (Brief PCS)(post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment))
- Feasibility of Collecting Patient Reported Outcomes of Anxiety as Assessed by the Number of Participants Who Completed the General Anxiety Disorder-7 (GAD-7) Questionnaire(post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment))
- Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8)(post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment))
- Feasibility of Collecting Patient Reported Outcomes of Mindfulness as Assessed by the Number of Participants Who Completed the Five Facet Mindfulness Questionnaire-15 (FFMQ-15)(post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment))
- Feasibility of Collecting Patient Reported Outcomes of Quality of Life as Assessed by the Number of Participants Who Completed the SCI-quality of Life (QOL): Positive Affect and Well Being-Short Form (PAWB-SF)(post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment))
- Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)(post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment))
- Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a(post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment))
- Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)(end of study (12 weeks post enrollment))
- Feasibility of Collecting Sleep Disturbance as Assessed by the Number of Participants Who Completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 4a(end of study (12 weeks post enrollment))
研究者
Radha Korupolu
Associate Professor
The University of Texas Health Science Center, Houston