Mindfulness And Placebo for Pain (MAPP) Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Arizona State University
Study ID
NCT06720909
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Jan 27, 2025
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MBSR-Only
    This experimental arm receives the 8-week MBSR program only.
  • Experimental: OLP-Only
    This experimental arm receives the OLP treatment only.
  • Experimental: MBSR+OLP
    This experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment.

Primary Outcome Measure

Feasibility - Feasibility of Participant Enrollment [ Time Frame: Enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Arizona State UniversityPhoenixArizona85004
Chung Jung Mun, PhD
[email protected]
602-496-0809
Chung Jung Mun, PhD (PRINCIPAL_INVESTIGATOR)
Mary Davis, PhD (SUB_INVESTIGATOR)
Michael Todd, PhD (SUB_INVESTIGATOR)
Frank LoVecchio, DO, MPH (SUB_INVESTIGATOR)
Arizona State University Downtown Phoenix CampusPhoenixArizona85004
Chung Jung Mun
[email protected]
(602) 496-2644

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