Mindfulness And Placebo for Pain (MAPP) Study (MAPP)

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction (MBSR); Other: Open-Label Placebo (OLP); Other: MBSR+OLP

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chung Jung Mun, PhD; Phone Number: 602-496-0809; Email: chungjung.mun@asu.edu
• Study Contact Backup: Name: Ryan Eckert, MS; Phone Number: 602-496-0665; Email: ryan.eckert@asu.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Not yet recruiting
      • Arizona State University
      • Sub-Investigator: Michael Todd, PhD
      • Contact: Chung Jung Mun, PhD; Phone Number: 602-496-0809; Email: chungjung.mun@asu.edu
      • Principal Investigator: Chung Jung Mun, PhD
      • Sub-Investigator: Mary Davis, PhD
      • Sub-Investigator: Frank LoVecchio, DO, MPH
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Arizona State University Downtown Phoenix Campus
      • Contact: Chung Jung Mun; Phone Number: (602) 496-2644; Email: cjmun@asu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBSR-Only; This experimental arm receives the 8-week MBSR program only.	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.
Experimental: OLP-Only; This experimental arm receives the OLP treatment only.	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.
Experimental: MBSR+OLP; This experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment.	Other: MBSR+OLP; This condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Feasibility of Participant Enrollment	Feasibility of participant enrollment will be benchmarked at 100% (N=45) proposed participant enrollment during the study.	Enrollment
Feasibility - Participant Retention	Participant retention will be benchmarked at a ≥75% retention rate from baseline to 3-month follow-up.	Enrollment to end of 3-month follow-up
Feasibility - MBSR Intervention Adherence	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.	Enrollment to end of 8-week treatment
Feasibility - Daily Diary Assessment Compliance	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.	Enrollment to end of 3-month follow-up
Acceptability - Appropriateness of Intervention Length and Frequency	Appropriateness of intervention length and frequency will be benchmarked as an average score of ≥75 from a 0-100 scale.	Enrollment to end of 8-week treatment
Acceptability - Appropriateness of Daily Diary Length and Frequency	Appropriateness of daily diary length and frequency will be benchmarked as an average score of ≥75 from a 0-100 scale.	Enrollment to end of 8-week treatment
Acceptability - Appropriateness of Other Study Measures	Appropriateness of other study measures will be benchmarked as an average score of ≥75 from a 0-100 scale.	Enrollment to end of 8-week treatment
Feasibility - OLP Treatment Adherence	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.	Enrollment to end of 8-week treatment
Acceptability - Global Satisfaction	Global satisfaction will be benchmarked as an average score of ≥75 from a 0-100 scale.	Enrollment to end of 8-week treatment
Acceptability - Perceived Intervention Effectiveness	Perceived intervention effectiveness will be benchmarked as an average score of ≥75 from a 0-100 scale.	Enrollment to end of 8-week treatment
Acceptability - Perceived Intervention Convenience	Perceived intervention convenience will be benchmarked as an average score of ≥75 from a 0-100 scale.	Enrollment to end of 8-week treatment
Acceptability - Perceived Intervention Side Effects	Perceived intervention side effects will be benchmarked as an average score of ≥75 from a 0-100 scale.	Enrollment to end of 8-week treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity	The Brief Pain Inventory (BPI) will be incorporated into daily diary assessment which will be completed by participants once per day for 7 consecutive days at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Pain severity will be determined by the mean of four BPI items (i.e., "average," "worst," "least" pain experienced in the past 24 hours, and pain experienced "right now"). All of these items are measured on a 0 to 10 Numerical Rating Scales (0 = "No pain", 10 = "Pain as bad as you can imagine").	Enrollment to end of 3-month follow-up
Pain Interference	The Brief Pain Inventory (BPI) will be incorporated into daily diary assessment which will be completed by participants once per day for 7 consecutive days at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Pain interference will be assessed by computing the mean of seven items that evaluate the extent to which an individual's pain has interfered with their general activity, mood, walking ability, normal work, relationship with others, sleep, and enjoyment of life within the past 24 hours. All of these items are measured on a 0 to 10 Numerical Rating Scales (0 = "No pain", 10 = "Pain as bad as you can imagine").	Enrollment to end of 3-month follow-up
Physical Functioning	The PROMIS Short Form v2.0 - Physical Function 8b will be incorporated into online, self-reported assessments delivered via REDCap which will be completed by participants at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Physical functioning will be assessed as the function of upper and lower extremities, central core regions, and the ability to complete daily activities on a 5-point Likert scale.	Enrollment to end of 3-month follow-up
Depression	The PROMIS Short Form v1.0 - Depression 8a will be incorporated into online, self-reported assessments delivered via REDCap which will be completed by participants at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Depression will be assessed by computing the mean of eight items that evaluate the extent to which depression-related symptoms are present on a 5-point Likert scale.	Enrollment to end of 3-month follow-up
Anxiety	The PROMIS Short Form v1.0 - Anxiety 8a will be incorporated into online, self-reported assessments delivered via REDCap which will be completed by participants at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Anxiety will be assessed by computing the mean of eight items that evaluate the extent to which anxiety-related symptoms are present on a 5-point Likert scale.	Enrollment to end of 3-month follow-up
Opiod Use	Questions pertaining to opioid analgesic us will be incorporated into daily diary assessment which will be completed by participants once per day for 7 consecutive days at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Opioid use will be assessed with various questions asking opioid use-related questions, including the frequency and dose.	Enrollment to end of 3-month follow-up
Patient Global Impression of Change	The Patient Global Impression of Change measure will be incorporated into online, self-reported assessments delivered via REDCap which will be completed by participants at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Belief of treatment efficacy will be assessed by computing the mean of seven items that evaluate the extent to which a participant believes their symptoms have improved on a 7-point Likert scale ranging from "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," to "very much worse".	Enrollment to end of 3-month follow-up
Mindfulness	The Mindful Attention Awareness Scale (MAAS) will be incorporated into online, self-reported assessments delivered via REDCap which will be completed by participants at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Mindfulness will be assessed by computing the mean of 15 items that evaluate the extent to which a participant is mindful throughout daily activities on a 6-point Likert scale ranging from "almost always," to "almost never".	Enrollment to end of 3-month follow-up
Pain Catastrophizing	The Pain Catastrophizing Scale (PCS) will be incorporated into online, self-reported assessments delivered via REDCap which will be completed by participants at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Pain catastrophizing will be assessed by computing the mean of 13 items that evaluate the extent to which a participant engages in pain-related thoughts on a 5-point Likert scale ranging from "not at all," to "all the time".	Enrollment to end of 3-month follow-up
Insomnia Symptoms	The Insomnia Severity Index (ISI) will be incorporated into online, self-reported assessments delivered via REDCap which will be completed by participants at four key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), (3) immediate post-treatment, and (4) the 3-month follow-up. Insomnia will be assessed by computing the mean of seven items that evaluate the extent to which a participant experiences insomnia symptoms on a 5-point Likert scale ranging from "none/not at all," to "very/very much".	Enrollment to end of 3-month follow-up
Conditioned Pain Modulation	Conditioned pain modulation (CPM) will be assessed using Quantitative Sensory Testing and will be delivered at three key time points: (1) baseline (prior to intervention exposure), (2) mid-treatment (at week 4), and (3) immediate post-treatment. Endogenous pain inhibition is assessed by the CPM index. A CPM Index will be quantified as the average percent change in pressure pain threshold during cold pressor task relative to the baseline pressure pain threshold.	Enrollment to end of 8-week treatment
Adverse Events	Reports of adverse events will be monitored throughout the study period for all study participants.	Enrollment to end of 3-month follow-up

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Chung Jung Mun, PhD, Arizona State University

Publications and helpful links

General Publications

• Mun CJ, Contreras E, Xiao Y, Eckert R, Harting A, Damera S, Perez I, Pandey HK, Mardian AS, LoVecchio F, Colloca L, Dunn KE, Todd M, Fillingim RB, Davis MC. Combining mindfulness intervention and open-label placebo treatment for chronic pain: a protocol for a feasibility study. Pilot Feasibility Stud. 2025 Aug 20;11(1):111. doi: 10.1186/s40814-025-01692-8.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; pain; placebo; mindfulness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID Numbers: STUDY00020051; 1R34AT012677 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No