Mindfulness And Placebo for Pain (MAPP) Study

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. 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

Conditions

• Chronic Pain

Interventions

BEHAVIORAL

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.

OTHER

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

MBSR+OLP

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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Arizona State University

  lead OTHER

Principal Investigators

• Chung Jung Mun, PhD · Arizona State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-27

Primary Completion

2027-03-01

Completion

2027-03-01

Countries

• United States

Study Locations