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Active Not Recruiting
NCT06720909
Mindfulness And Placebo for Pain (MAPP) Study
Conditions: Chronic Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: Arizona State University
Location: Arizona State University Downtown Phoenix Campus Phoenix Arizona
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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06720909). StuddyBuddy aggregates publicly available trial information.