Evaluation of a Mind-Body Application in Combination With a Graded Movement Program for the Treatment of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Brief Pain Inventory-short form (BPI-SF) Pain Severity
研究概览
简要总结
The investigators are evaluating the effects of a mind-body mobile application, in combination with a guided movement program, on the experience of chronic pain. Participants meeting the criteria for chronic/persistent pain (confirmed via self-report) will complete an online baseline questionnaire. Eligible participants will take part in an intervention that involves use of a 6-week free trial of a mind-body focused mobile application in combination with virtual asynchronous audio-guided somatic education sessions (gentle movement). External data from a usual care control arm and a mobile-app-only arm from a previous study by the same research team, National Clinical Trials (NCT) registry number NCT05090683, will be used for comparison with the current combined intervention. All participants will complete online surveys at the start of the study and after 6 weeks to measure pain intensity and interference (primary outcomes), mental health outcomes (depression, anxiety, stress), pain-related thoughts (pain catastrophizing), quality of life, and fear of movement (secondary outcomes). From weeks 2 to 6, participants will fill out weekly surveys to track how often they engage with each: the somatic education (gentle movement) program and the mobile app. Participants will also complete a follow-up survey at 12 weeks (6 weeks post-intervention conclusion).
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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants must have access to an electronic device
- •Participants must be willing to engage in weekly somatic education activities
排除标准
- •Individuals reporting a cognitive impairment that can interfere with completing questionnaires and using a mobile application.
- •Individuals reporting substance use disorder (within the last 6 months).
- •Individuals reporting any of the following medical conditions: metastatic cancer, rheumatoid arthritis, lupus, scleroderma, polymyositis.
- •Individuals with previous experience with the mind-body app under study (Note: use of "Calm" or another meditation-only app is not an exclusion).
- •Individuals with current regular (at least once a week) engagement with a somatic movement program (e.g., Feldenkrais, Hanna Somatics, Somatic Yoga, Tai Chi, Pilates)
结局指标
主要结局
Change in Brief Pain Inventory-short form (BPI-SF) Pain Severity
时间窗: Baseline, 6 weeks.
Measures self reported pain severity (over past 24 hours). BPI Pain Severity: single item scale within larger Brief Pain Inventory tool that asses pain "average" pain severity. Item scale ranges from 0 to 10. 0 = "no pain", 10 = "pain as bad as you can imagine". Higher scores indicate worse outcome (pain severity), lower scores indicate better outcome. Item range = (0,10).
Change in Brief Pain Inventory-short form (BPI-SF) Pain Interference
时间窗: Baseline, 6 weeks.
Item 9 on the BPI measures interference with daily living. There are 7 items (reflecting seven daily activities) 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 (higher interference).
次要结局
- Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity short form 3a(Baseline, 6 weeks, 12 weeks)
- Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference short form 8a(Baseline, 6 weeks, 12 weeks)
- Change in Pain Catastrophizing Questionnaire (PCS)(Baseline, 6 and 12 weeks)
- Change in Tampa Scale of Kinesiophobia Questionnaire (TSK)(Baseline, 6 and 12 weeks)
- Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity short form 3a(Baseline, 6 weeks, 12 weeks)
- Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference short form 8a(Baseline, 6 weeks, 12 weeks)
- Change in Depression, Anxiety, and Stress Scale (DASS-21)(Baseline, 6 and 12 weeks)
- Change in Quality of Life Short Form 12 (SF-12) Physical Component Score(Baseline, 6 and 12 weeks)
- Change in Pain Catastrophizing Questionnaire (PCS)(Baseline, 6 and 12 weeks)
- Change in Quality of Life Short Form 12 (SF-12) Mental Component Score(Baseline, 6 and 12 weeks)
- Change in Tampa Scale of Kinesiophobia Questionnaire (TSK)(Baseline, 6 and 12 weeks)
- Change in Brief Pain Inventory Pain Severity Composite Score(baseline, 6 weeks, 12 weeks)
- Change in Brief Pain Inventory Pain Severity (from baseline to 12 weeks)(baseline, 12 weeks)
- Change in Brief Pain Inventory Interference (from baseline to 12 weeks)(baseline, 12 weeks)