An interventional study of Mindfulness-Based Stress Reduction (MBSR) and Open-Label Placebo (OLP) in Chronic Pain, sponsored by Arizona State University. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Arizona State University · Not applicable, Interventional, and Treatment
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:
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Arizona State University is the lead sponsor of 234 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This experimental arm receives the 8-week MBSR program only.
Behavioral: Mindfulness-Based Stress Reduction (MBSR)
This experimental arm receives the OLP treatment only.
Other: Open-Label Placebo (OLP)
This experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment.
Other: MBSR+OLP
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.
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.
This condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.
Feasibility - Feasibility of Participant Enrollment
Feasibility of participant enrollment will be benchmarked at 100% (N=45) proposed participant enrollment during the study.
Time frame: Enrollment
Feasibility - Participant Retention
Participant retention will be benchmarked at a ≥75% retention rate from baseline to 3-month follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Enrollment to end of 8-week treatment
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").
Time frame: 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").
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: Enrollment to end of 8-week treatment
Adverse Events
Reports of adverse events will be monitored throughout the study period for all study participants.
Time frame: Enrollment to end of 3-month follow-up
Plan to share: Undecided
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Arizona State University