Mindfulness And Placebo for Pain (MAPP) Study
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArizona State University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-Based Stress Reduction (MBSR)
BehavioralThe 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 interventionThe 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 interventionThis condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: MBSR-OnlyExperimental treatment 1 intervention
Group B: OLP-OnlyExperimental treatment 1 intervention
Group C: MBSR+OLPExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - Feasibility of Participant Enrollment
Feasibility of participant enrollment will be benchmarked at 100% (N=45) proposed participant enrollment during the study.
Time frame
Enrollment2
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-up3
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 treatment4
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 treatmentOther outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
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Arizona State University
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov