Chronic Pain
Conditions
Keywords
chronic pain, pain, mindfulness, placebo
Brief summary
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: 1. Mindfulness-Based Stress Reduction (MBSR) 2. OLP treatment 3. combination of MBSR and OLP treatment
Interventions
BEHAVIORALMindfulness-Based Stress Reduction (MBSR)
The standard 8-week MBSR program will be led by certified MBSR instructors from the UCSD Center for Mindfulness. The program content will consist of a variety of mindfulness and meditative techniques, such as sitting meditation, body scans, and mindful yoga. Participants will engage in weekly sessions via Zoom, participation in group discussions, and honing their other mindfulness skills. Throughout the program, participants will be instructed to commit to a daily mindfulness meditation practice lasting approximately 45 minutes, at least 6 days a week.
The placebo pills will be size #1 capsules filled with (1) microcrystalline cellulose, a common inert excipient for pharmaceuticals, and (2) 25 mg riboflavin tracer. Participants will be informed that the placebo pills are inactive substances, like sugar pills, and contain no active medication. Then, they will watch a brief introduction video which will cover four main discussion points: (1) the placebo effect can be powerful and can have beneficial effects for diverse symptoms, (2) the body can respond to taking placebo pills automatically despite the knowledge that it is placebo (e.g., Pavlov's dogs), (3) a positive attitude or expectation can be beneficial but is not necessary, and (4) taking the pills faithfully throughout the intervention period is critical.
OTHERMBSR+OLP
This condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.
Sponsors
Arizona State University
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old; 2. ability to speak, write, and read in English; 3. physical pain present on at least half the days in the past 3 months; and 4. average past week pain severity rating ≥3 on a 0-10 Numerical Rating Scale.
Exclusion criteria
1. acute pain due to recent injury or surgery; 2. self-reporting of chronic malignant pain (e.g., cancer, HIV); 3. self-reporting of Raynaud's disease (those who can be contraindicated for cold pressor testing); 4. severe psychopathology (e.g., a psychotic disorder) or significant cognitive deficits judged to interfere with study procedures; 5. currently pregnant or breastfeeding; 6. 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); 7. inability to commit to study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Feasibility of Participant Enrollment | Enrollment | Feasibility of participant enrollment will be benchmarked at 100% (N=45) proposed participant enrollment during the study. |
| Feasibility - Participant Retention | 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 | 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 | 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 | 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 - Global Satisfaction | 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 | 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 | 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 | 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 Intervention Length and Frequency | 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 - Appropriateness of Daily Diary Length and Frequency | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChung Jung Mun, PhD
Arizona State University
Outcome results
None listed