Clinical trial NCT06720909: Mindfulness And Placebo for Pain (MAPP) Study
Official title: Feasibility of Combining Mindfulness Intervention and Open-Label Placebo Treatment for Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
pain
mindfulness
placebo
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-12-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility - Feasibility of Participant Enrollment
timeFrame: Enrollment
measure: Feasibility - Participant Retention
timeFrame: Enrollment to end of 3-month follow-up
measure: Feasibility - MBSR Intervention Adherence
timeFrame: Enrollment to end of 8-week treatment
measure: Feasibility - OLP Treatment Adherence
timeFrame: Enrollment to end of 8-week treatment
measure: Feasibility - Daily Diary Assessment Compliance
timeFrame: Enrollment to end of 3-month follow-up
measure: Acceptability - Global Satisfaction
timeFrame: Enrollment to end of 8-week treatment
measure: Acceptability - Perceived Intervention Effectiveness
timeFrame: Enrollment to end of 8-week treatment
measure: Acceptability - Perceived Intervention Convenience
timeFrame: Enrollment to end of 8-week treatment
measure: Acceptability - Perceived Intervention Side Effects
timeFrame: Enrollment to end of 8-week treatment
measure: Acceptability - Appropriateness of Intervention Length and Frequency
timeFrame: Enrollment to end of 8-week treatment
measure: Acceptability - Appropriateness of Daily Diary Length and Frequency
timeFrame: Enrollment to end of 8-week treatment
measure: Acceptability - Appropriateness of Other Study Measures
timeFrame: Enrollment to end of 8-week treatment
Secondary outcomes:
Other outcomes:
measure: Pain Severity
timeFrame: Enrollment to end of 3-month follow-up
measure: Pain Interference
timeFrame: Enrollment to end of 3-month follow-up
measure: Physical Functioning
timeFrame: Enrollment to end of 3-month follow-up
measure: Depression
timeFrame: Enrollment to end of 3-month follow-up
measure: Anxiety
timeFrame: Enrollment to end of 3-month follow-up
measure: Opiod Use
timeFrame: Enrollment to end of 3-month follow-up
measure: Patient Global Impression of Change
timeFrame: Enrollment to end of 3-month follow-up
measure: Mindfulness
timeFrame: Enrollment to end of 3-month follow-up
measure: Pain Catastrophizing
timeFrame: Enrollment to end of 3-month follow-up
measure: Insomnia Symptoms
timeFrame: Enrollment to end of 3-month follow-up
measure: Conditioned Pain Modulation
timeFrame: Enrollment to end of 8-week treatment
measure: Adverse Events
timeFrame: Enrollment to end of 3-month follow-up
Locations:
city: Phoenix
country: United States
facility: Arizona State University Downtown Phoenix Campus
state: Arizona
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Chung Jung Mun, PhD
role: PRINCIPAL_INVESTIGATOR
References: