Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory-short Form (BPI-SF)
研究概览
简要总结
We are investigating the effects of a mind-body based mobile application on the experience of chronic pain.
Participants meeting our criteria for chronic pain (confirmed via self-report) will complete an online baseline questionnaire. Eligible participants will be enrolled in the study and randomized into control (usual care, waitlisted) or intervention group (6-week mind-body based mobile application intervention). Randomization will be stratified by pain intensity and gender using computer-generated block randomization to create varying block sizes of 4 and 8. We will run the trial in multiple cohorts in series to obtain desired sample size.
All participants will complete online questionnaires at baseline and post-intervention at 6 weeks that measure pain intensity, interference with daily living, pain perceptions, mental health outcomes, and medication use. Participants will also complete weekly questionnaires on weeks 2 to 6 to gauge frequency of application usage (intervention) or other pain treatments (control). Participants in the intervention group will be asked to repeat the follow-up questionnaire at 12-weeks.
详细描述
See protocol for more details. (submitted at time of registration)
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
- None
盲法说明
Participants in the control group will be aware that they have are serving as controls that have been wait-listed for access to the mobile application.
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 19 to 75 years with chronic pain.
- •chronic pain is defined as having non-malignant chronic or persistent pain for at least 6 months.
- •Participants must experience pain at least half the days in the last 6 months.
- •Pain can include bodily pain or head (migraine) pain.
排除标准
- •Individuals reporting a cognitive impairment that can interfere with completing questionnaires and using a mobile application.
- •Individuals reporting any of the following psychiatric illness: schizophrenia, dissociative or personality disorders, bipolar disorder.
- •Individuals reporting any of the following medical conditions: metastatic cancer, rheumatoid arthritis, lupus, scleroderma, polymyositis.
- •Individuals reporting substance use disorder (within the last 6 months).
- •Individuals that have previously used mind-body apps for the treatment of chronic pain.
结局指标
主要结局
Brief Pain Inventory-short Form (BPI-SF)
时间窗: Baseline, 6 weeks
Primary outcome of Pain Severity: Single item scale within larger Brief Pain Inventory tool. Item scale ranges from 0 to 10. 0 = "no pain", 10 = "pain as bad as you can imagine". Higher scores indicate worse outcome, lower scores indicate better outcome. Item range = (0,10). Primary outcome of Pain Interference: Item 9 on BPI measures interference with daily living. There are 7 items embedded within and each is scored on 11-point scales from 0 = "does not interfere" to 10 = "completely interferes" for interference with activities of daily living. Pain interference score is calculated as an average of the 7 items, with a range from 0 to 10. Higher scores represent worse outcomes.
次要结局
- Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average(baseline, 6 weeks)
- Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference(baseline, 6 weeks)
- Pain Catastrophizing Questionnaire (PCS)(12 weeks)
- DASS-21 (Depression, Anxiety, and Stress Scale)(baseline, 6 weeks)
- Quality of Life Short Form 12 (SF-12) Physical (PCS-12) and Mental (MCS-12) Component Summary Scores (Z-scores; Normalized Based on US General Population)(12 weeks)
- Brief Pain Inventory-short Form (BPI-SF)(12 weeks)
- PROMIS Pain Intensity Short Form(12 weeks)
- Medication Use(6 weeks)
- DASS-21 (Depression, Anxiety, Stress Scale - 21 Items)(12 weeks)
- PROMIS Pain Interference Short Form 8a(12 weeks)