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NCT Number: NCT06720909

Mindfulness And Placebo for Pain (MAPP) Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

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.

Open-Label Placebo (OLP)

Other

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.

MBSR+OLP

Other

This condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Other outcomes

  1. Pain Severity

    Time frame: Enrollment to end of 3-month follow-up

    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").

  2. Pain Interference

    Time frame: Enrollment to end of 3-month follow-up

    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").

  3. Physical Functioning

    Time frame: Enrollment to end of 3-month follow-up

    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.

  4. Depression

    Time frame: Enrollment to end of 3-month follow-up

    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.

  5. Anxiety

    Time frame: Enrollment to end of 3-month follow-up

    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.

  6. Opiod Use

    Time frame: Enrollment to end of 3-month follow-up

    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.

  7. Patient Global Impression of Change

    Time frame: Enrollment to end of 3-month follow-up

    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".

  8. Mindfulness

    Time frame: Enrollment to end of 3-month follow-up

    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".

  9. Pain Catastrophizing

    Time frame: Enrollment to end of 3-month follow-up

    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".

  10. Insomnia Symptoms

    Time frame: Enrollment to end of 3-month follow-up

    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".

  11. Conditioned Pain Modulation

    Time frame: Enrollment to end of 8-week treatment

    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.

  12. Adverse Events

    Time frame: Enrollment to end of 3-month follow-up

    Reports of adverse events will be monitored throughout the study period for all study participants.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: MAPP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 6, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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