Mindfulness and Placebo for Pain (MAPP) Study

Not Applicable

Recruiting

• Conditions: Chronic Pain

• Registration Number: NCT06720909
• Lead Sponsor: Arizona State University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Status Verified: 2025-01
• Study Start: 2025-01-27
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility - Participant Retention	Enrollment to end of 3-month follow-up	Participant retention will be benchmarked at a ≥75% retention rate from baseline to 3-month follow-up.
Feasibility - Feasibility of Participant Enrollment	Enrollment	Feasibility of participant enrollment will be benchmarked at 100% (N=45) proposed participant enrollment during the study.
Feasibility - MBSR Intervention Adherence	Enrollment to end of 8-week treatment	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.
Feasibility - OLP Treatment Adherence	Enrollment to end of 8-week treatment	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.
Feasibility - Daily Diary Assessment Compliance	Enrollment to end of 3-month follow-up	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.
Acceptability - Appropriateness of Intervention Length and Frequency	Enrollment to end of 8-week treatment	Appropriateness of intervention length and frequency will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Global Satisfaction	Enrollment to end of 8-week treatment	Global satisfaction will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Perceived Intervention Effectiveness	Enrollment to end of 8-week treatment	Perceived intervention effectiveness will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Perceived Intervention Convenience	Enrollment to end of 8-week treatment	Perceived intervention convenience will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Perceived Intervention Side Effects	Enrollment to end of 8-week treatment	Perceived intervention side effects will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Appropriateness of Daily Diary Length and Frequency	Enrollment to end of 8-week treatment	Appropriateness of daily diary length and frequency will be benchmarked as an average score of ≥75 from a 0-100 scale.
Acceptability - Appropriateness of Other Study Measures	Enrollment to end of 8-week treatment	Appropriateness of other study measures will be benchmarked as an average score of ≥75 from a 0-100 scale.

Trial Locations

Locations (2)

Arizona State University Downtown Phoenix Campus; 🇺🇸 Phoenix, Arizona, United States

Arizona State University; 🇺🇸 Phoenix, Arizona, United States