Feasibility of Combining Mindfulness Intervention and Open-Label Placebo Treatment for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Feasibility - Feasibility of Participant Enrollment
研究概览
简要总结
This study proposes a three-arm randomized-controlled trial (RCT) that evaluates the feasibility and acceptability of combining a mindfulness-based therapy (MBT) and open-label placebo (OLP) treatment for individuals with chronic pain. Individuals with chronic pain will be recruited to participate in an 8-week trial, with a subsequent 3-month post-treatment follow-up.
Participants will be randomly assigned to one of the following three conditions:
- Mindfulness-Based Stress Reduction (MBSR)
- OLP treatment
- combination of MBSR and OLP treatment
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
- •≥18 years old;
- •ability to speak, write, and read in English;
- •physical pain present on at least half the days in the past 3 months; and
- •average past week pain severity rating ≥3 on a 0-10 Numerical Rating Scale.
排除标准
- •acute pain due to recent injury or surgery;
- •self-reporting of chronic malignant pain (e.g., cancer, HIV);
- •self-reporting of Raynaud's disease (those who can be contraindicated for cold pressor testing);
- •severe psychopathology (e.g., a psychotic disorder) or significant cognitive deficits judged to interfere with study procedures;
- •currently pregnant or breastfeeding;
- •inability to discontinue use of vitamin B2 supplements or a multivitamin containing vitamin B2 throughout the study period (these interfere with riboflavin tracer-OLP treatment adherence-monitoring);
- •inability to commit to study period.
研究组 & 干预措施
MBSR-Only
This experimental arm receives the 8-week MBSR program only.
干预措施: Mindfulness-Based Stress Reduction (MBSR) (Behavioral)
MBSR+OLP
This experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment.
干预措施: MBSR+OLP (Other)
OLP-Only
This experimental arm receives the OLP treatment only.
干预措施: Open-Label Placebo (OLP) (Other)
结局指标
主要结局
Feasibility - Feasibility of Participant Enrollment
时间窗: Enrollment
Feasibility of participant enrollment will be benchmarked at 100% (N=45) proposed participant enrollment during the study.
Feasibility - Participant Retention
时间窗: Enrollment to end of 3-month follow-up
Participant retention will be benchmarked at a ≥75% retention rate from baseline to 3-month follow-up.
Feasibility - MBSR Intervention Adherence
时间窗: Enrollment to end of 8-week treatment
Intervention adherence for MBSR will be benchmarked as an average of ≥75% (6 out of 8) MBSR session completion AND and average of ≥75% daily mindfulness homework completion.
Feasibility - OLP Treatment Adherence
时间窗: Enrollment to end of 8-week treatment
Intervention adherence for OLP treatment will be benchmarked as an average of ≥75% adherence to OLP treatment based upon percent days OLP consumed measured by MEMS (Medication Event Monitoring System) SmartCap AND detection of riboflavin tracer in urine samples during both the mid- and post-treatment sessions.
Feasibility - Daily Diary Assessment Compliance
时间窗: Enrollment to end of 3-month follow-up
Daily diary assessment compliance will be benhcmarked as an average of ≥75% compliance throughout the study period including baseline, mid-treatment, post-treatment, and 3-month follow-up.
Acceptability - Appropriateness of Intervention Length and Frequency
时间窗: Enrollment to end of 8-week treatment
Appropriateness of intervention length and frequency will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Global Satisfaction
时间窗: Enrollment to end of 8-week treatment
Global satisfaction will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Perceived Intervention Effectiveness
时间窗: Enrollment to end of 8-week treatment
Perceived intervention effectiveness will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Perceived Intervention Convenience
时间窗: Enrollment to end of 8-week treatment
Perceived intervention convenience will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Perceived Intervention Side Effects
时间窗: Enrollment to end of 8-week treatment
Perceived intervention side effects will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Appropriateness of Daily Diary Length and Frequency
时间窗: Enrollment to end of 8-week treatment
Appropriateness of daily diary length and frequency will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Appropriateness of Other Study Measures
时间窗: Enrollment to end of 8-week treatment
Appropriateness of other study measures will be benchmarked as an average score of ≥75 from a 0-100 scale.
次要结局
未报告次要终点
研究者
Chung Jung Mun
Assistant Professor
Arizona State University