Mindfulness and Placebo for Pain (MAPP) Study

Arizona State University (ASU)

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: Mindfulness-Based Stress Reduction (MBSR); Other: MBSR+OLP; Other: Open-Label Placebo (OLP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06720909

1R34AT012677 (U.S. NIH Grant/Contract)

STUDY00020051

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years old;
2. ability to speak, write, and read in English;
3. physical pain present on at least half the days in the past 3 months; and
4. average past week pain severity rating ≥3 on a 0-10 Numerical Rating Scale.

Exclusion criteria

1. acute pain due to recent injury or surgery;
2. self-reporting of chronic malignant pain (e.g., cancer, HIV);
3. self-reporting of Raynaud's disease (those who can be contraindicated for cold pressor testing);
4. severe psychopathology (e.g., a psychotic disorder) or significant cognitive deficits judged to interfere with study procedures;
5. currently pregnant or breastfeeding;
6. 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);
7. inability to commit to study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

MBSR-Only

Experimental group

Description:

This experimental arm receives the 8-week MBSR program only.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

OLP-Only

Experimental group

Description:

This experimental arm receives the OLP treatment only.

Treatment:

Other: Open-Label Placebo (OLP)

MBSR+OLP

Experimental group

Description:

This experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment.

Treatment:

Other: MBSR+OLP