Integrating Mind Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Heterogeneous Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint
研究概览
简要总结
The aims of this study are to adapt, pilot, and examine the credibility, acceptability, and feasibility of an evidence-based mind-body program, the Relaxation Response Resiliency Program for Chronic Pain (p3RP), and the p3RP-Digital Monitoring Device (p3RP-DMD), which is the p3RP integrated with a commercial DMD, the Fitbit.
详细描述
The study has three phases. In phase I, the investigators are adapting the 3RP as a multidisciplinary team, and then conducting two focus groups. In phase two, the investigators are piloting the p3RP and p3RP-DMD. In phase three, the investigators are conducting a small randomized-controlled trial of the p3RP versus p3RP-DMD.
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
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
- •Male and female patients, age 18 years or older
- •Have nonmalignant chronic pain for more than 3 months
- •Able to perform a 6-minute walk test
- •Owns a smartphone with Bluetooth 4.0
- •Willingness and ability to participate in the 3RP intervention and to comply with the requirements of the study protocol (including weekly sessions and DMD use)
- •Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose
- •Cleared by a medical doctor for study participation
- •Leads a sedentary lifestyle
排除标准
- •Diagnosed with medical illness expected to worsen in the next 6 months
- •Serious mental illness or instability for which hospitalization may be likely in the next 6 months
- •Current suicidal ideation reported on self-report
- •Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
- •Current substance use disorder, within the past 6 months
- •Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less
- •Regular use of DMD in the last 3 months
- •Engagement in regular intensive physical exercise for >30 minute daily
- •Unable to walk without use of assistance (e.g., wheelchair, walker)
结局指标
主要结局
Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint
时间窗: Post-Test (10 Weeks)
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Therapist Adherence
时间窗: Collected during the intervention
Two independent coders rated whether clinicians delivered each component of study sessions (e.g., deep breathing, providing education on prevalent myths about chronic pain) , exhibited skillful delivery (e.g., active listening, validation), and followed study protocol (e.g., collecting home practice sheets, logging attendance). Each individual component was rated on a yes/no scale. The adherent ("yes") components were summed, tallied against the total number of components in the adherence checklist, and averaged between the 2 reviewers. The score represents a total rate of adherence.
Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days
时间窗: Baseline (0 Weeks), Post-Test (10 Weeks)
Rate of participant's use of ActiGraph watch for a period of one week at both baseline and post-treatment assessments. A valid day of wear consisted of at least 7 hours of wear time.
Program Safety - Number of Adverse Events Related to Study Participation
时间窗: Baseline (0 Weeks), Post-Test (10 Weeks)
Any self-reported or observed negative events related to participation.
Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria
时间窗: Baseline (0 Weeks), Post-Test (10 Weeks)
Rate of participant's completion of homework assigned throughout the study. Logs were considered adherent if participants completed 3 home practice components 3 out of 7 days per week or 1 home practice component 5 out of 7 days per week.
Feasibility of Quantitative Measures
时间窗: Baseline (0 Weeks), Post-Test (10 Weeks)
The number of participants that completed quantitative measures. Rate of participant's completion of self-report measures administered at baseline and post-test assessments.
Credibility and Expectancy Questionnaire (CEQ)
时间窗: Baseline (0 Weeks)
Number of participants who score above the midpoint on two subscales assessed using frequencies and proportions. The measure involves two subscales: credibility (questions 1-3) and expectancy (questions 4-6). Subscale scores range from 3 to 27. Higher scores indicate greater perceived credibility and greater belief that treatment will help.
Program Acceptability
时间窗: Post-Test (10 Weeks)
Assessed via the percentage of participants who attended at least 7 out of 10 sessions.
次要结局
- Pain Catastrophizing Scale (PCS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Tampa Kinesiophobia Scale (TKS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Measure of Current Status (MOCS-A)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Patient Global Impression of Change (PGIC)(Post-Test (10 Weeks))
- Pittsburgh Sleep Quality Index (PSQI)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- WHO Disability Assessment Schedule 2.0 (WHODAS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Numerical Rating Scale(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Pain Resilience Scale (PRS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Cognitive and Affective Mindfulness Scale (CAMS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- 6-Min Walk Test Distance(6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks).)
- ActiGraph Average Steps(1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks))
- Patient Global Impression of Change (PGIC)(Post-Test (10 Weeks))
- Physical Activity Scale for Persons With Physical Disabilities (PASIPD)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- WHO Disability Assessment Schedule 2.0 (WHODAS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Patient-Reported Outcomes Measurement Information System Physical Function v.8b(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Patient-Reported Outcomes Measurement Information System Anxiety v.8a(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Patient-Reported Outcomes Measurement Information System Depression v.8b(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Pain Resilience Scale (PRS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Numerical Rating Scale(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Cognitive and Affective Mindfulness Scale (CAMS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Pittsburgh Sleep Quality Index (PSQI)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Patient-Reported Outcomes Measurement Information System Social Isolation v.4a(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Patient-Reported Outcomes Measurement Information System Emotional Support v.4a(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Pain Catastrophizing Scale (PCS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Tampa Kinesiophobia Scale (TKS)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
- Measure of Current Status (MOCS-A)(Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks))
研究者
Ana-Maria Vranceanu, PhD
Clinical Psychologist
Massachusetts General Hospital