RecruitingNot ApplicableNCT06720909

Mindfulness And Placebo for Pain (MAPP) Study

Feasibility of Combining Mindfulness Intervention and Open-Label Placebo Treatment for Chronic Pain

Sponsor

Arizona State University

Enrollment

45 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Pain

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

Min Age: 18 Years

Inclusion Criteria4

≥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.

Exclusion Criteria7

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.

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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.

OTHEROpen-Label Placebo (OLP)

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.