SCI Pain App Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed
研究概览
简要总结
The purpose of this study is to find out if using an app is a feasible and acceptable treatment for chronic pain in persons with spinal cord injury. Participants will have a 50% chance of being asked to listen to 10 minutes of audio-guided meditations using an app each day for six weeks, and a 50% chance of being asked to listen to 10 minutes of engaging and distracting presentations about topics of interest to the individual (TED Talks) for six weeks. All participants will be asked to complete three online surveys about their emotional and physical health lasting 20-30 minutes (one when the participant first enters the study, one six weeks later, and another six weeks later). Additionally, participants will be asked to complete brief (<5 minute) online surveys once a week during the first six weeks of their participation. Participation in this study is very low risk, and participants may not experience any personal benefit from their participation. Participation in this study is entirely voluntary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •are at least 18 years of age
- •have a traumatic SCI of at least 6 months duration
- •have 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 understand the goals, procedures, time involved, and the time involved in participation, participate in the intervention and complete study surveys.
排除标准
- •have a significant visual or hearing impairment that limits their ability to participate in the app/computer-based intervention
- •lack access to and the ability to use a smart phone or smart tablet (e.g., iPad)
- •are unable to provide or obtain an email address for communication
- •practiced any kind of meditation more than once a week in the past 3 months
研究组 & 干预措施
Mindfulness Meditation (MM) App
Participants randomized to the MM condition will be asked to download and use the free Mindfulness Coach app (available for iOS and Android platforms) developed by the Veteran Affairs National Center for PTSD. The app offers written information about mindfulness as well as 12 audio-guided meditations each lasting 8-13 minutes. Participants will attend a live videochat orientation to the study with the research coordinator (RC) to receive assistance in downloading and using the app. Participants will be asked to listen to at least one, and ideally two, audio-guided meditation exercises using the app daily for six weeks. The RC will ask participants to complete weekly logs of their MM app use via a Qualtrics survey sent via email.
干预措施: Mindfulness Meditation App (Behavioral)
Engagement and Distraction (ED) App
Participants randomized to the Engagement and Distraction condition will be asked to download and use the free TED Talk app (available for iOS and Android platforms). The app offers many videos of engaging and distracting presentations about technology, entertainment, and design. The research coordinator will work with the participant to create a customized list of Ted Talk videos, each lasting 6-12 minutes, based on participants' personal interests. Participants will be asked to listen to or watch at least one, and ideally two, presentations using the app daily for six weeks. The research coordinator will ask participants to complete weekly logs of their TED Talk app use via a Qualtrics survey sent via email.
干预措施: Engagement and Distraction App (Behavioral)
结局指标
主要结局
Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed
时间窗: Immediately post-intervention (i.e., 6-weeks post-baseline)
proportion of assigned home practice completed by participants
Feasibility of Immediate Post-Intervention Follow-Up Assessment as assessed by the proportion of participants who complete immediate post-intervention follow up assessment
时间窗: Immediately post-intervention (i.e., 6-weeks post-baseline)
proportion of participants who complete immediate post-intervention follow up assessment
Feasibility of 6-Week Follow-Up Assessment as assessed by the proportion of participants who complete 6 weeks post-intervention follow up assessment
时间窗: 6 weeks post-intervention (i.e., 12-weeks post-baseline)
proportion of participants who complete 6 weeks post-intervention follow up assessment
Participant Satisfaction as assessed by a satisfaction questionnaire adapted from the Client Satisfaction Questionnaire for Internet-based Interventions (CSQ-I)
时间窗: Immediately post-intervention (i.e., 6-weeks post-baseline)
participant reported satisfaction with their assigned condition; scores range from 12-48, with higher scores indicating greater satisfaction
次要结局
- International SCI Pain Basic Data Subset Questionnaire(Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline))
- Chronic Pain Acceptance Questionnaire(Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline))
- Five Facet Mindfulness Questionnaire-Short Form(Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline))
- Patient Health Questionnaire-8 item(Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline))
- Generalized Anxiety Disorder Questionnaire-7(Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline))
- SCI-QOL Positive Affect and Wellbeing Questionnaire(Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline))
研究者
Susan Robinson Whelen
Principal Investigator
Baylor College of Medicine