Chronic PainMAPPNCT06720909
Mindfulness And Placebo for Pain (MAPP) Study
A study testing Mindfulness-Based Stress Reduction (MBSR) and MBSR+OLP in people with Chronic Pain, run by Arizona State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR) and MBSR+OLP
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arizona State University Downtown Phoenix Campus
Phoenix, Arizona, 85004
Arizona State University
Phoenix, Arizona, 85004
About this study
Official title: 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:
- Mindfulness-Based Stress Reduction (MBSR)
- OLP treatment
- combination of MBSR and OLP treatment
- Conditions
- Chronic Pain
- Being tested
- Mindfulness-Based Stress Reduction (MBSR), Open-Label Placebo (OLP), MBSR+OLP
- Keywords
- chronic pain, pain, mindfulness, placebo
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
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+OLPOther
This condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.
| Study group | Role | What they receive |
|---|---|---|
| MBSR-Only | Experimental | This experimental arm receives the 8-week MBSR program only. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
| OLP-Only | Experimental | This experimental arm receives the OLP treatment only. Receives: Other: Open-Label Placebo (OLP) |
| MBSR+OLP | Experimental | This experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment. Receives: Other: MBSR+OLP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Feasibility of Participant Enrollment
Feasibility of participant enrollment will be benchmarked at 100% (N=45) proposed participant enrollment during the study.
Measured: Enrollment
Feasibility - Participant Retention
Participant retention will be benchmarked at a ≥75% retention rate from baseline to 3-month follow-up.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Enrollment to end of 3-month follow-up
Acceptability - Global Satisfaction
Global satisfaction will be benchmarked as an average score of ≥75 from a 0-100 scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Enrollment to end of 8-week treatment
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.
Measured: 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.
Measured: 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.
Measured: Enrollment to end of 8-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start27 Jan 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Chung Jung Mun, Arizona State University
- Investigators
- Chung Jung Mun, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720909
- Sponsor's protocol ID
- STUDY00020051
- Other IDs
- 1R34AT012677
- Acronym
- MAPP
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 40836262
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Combining Mindfulness Intervention and Open-Label Placebo Treatment for Chronic Pain
- ClinicalTrials.gov ID
- NCT06720909
- Acronym / sponsor ID
- MAPP / STUDY00020051
- Conditions
- Chronic Pain
- Keywords
- chronic pain, pain, mindfulness, placebo
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Mindfulness-Based Stress Reduction (MBSR)
- OLP treatment
- combination of MBSR and OLP treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBSR-Only | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR)This experimental arm receives the 8-week MBSR program only. |
| OLP-Only | Experimental | Other: Open-Label Placebo (OLP)This experimental arm receives the OLP treatment only. |
| MBSR+OLP | Experimental | Other: MBSR+OLPThis experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MBSR-Only |
| 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 | OLP-Only |
| MBSR+OLPThis condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments. | Other | MBSR+OLP |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Derived from this study: PubMed 40836262Mun 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Jung Mun, PhD principal investigator
Arizona State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) and MBSR+OLP in people with Chronic Pain, run by Arizona State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Feasibility of Participant Enrollment (time frame: Enrollment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06720909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.