NCT06720909 · Arizona State University
Mindfulness And Placebo for Pain (MAPP) Study
(MAPP)
What this study is about
This study proposes a three-treatment group$1 randomly assigned-controlled trial (RCT) that evaluates the feasibility and acceptability of combining a mindfulness-based therapy (MBT) and where both patients and doctors know the treatment given placebo (OLP) treatment for individuals with chronic pain.
View original scientific description
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.
Interventions
BEHAVIORAL
Mindfulness-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.
OTHER
Open-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.
OTHER
MBSR+OLP
This condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.
Primary outcome measures
Feasibility - Feasibility of Participant Enrollment
Time frame: Enrollment
Feasibility of participant enrollment will be benchmarked at 100% (N=45) proposed participant enrollment during the study.
Feasibility - Participant Retention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥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 criteria
- 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.
Where
- Phoenix, Arizona
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations