Combining mindfulness therapy and placebo for chronic pain management
Feasibility of Combining Mindfulness Intervention and Open-Label Placebo Treatment for Chronic Pain
NA · Arizona State University · NCT06720909
This study is testing if combining mindfulness therapy with a placebo can help people with chronic pain feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Arizona State University (other) |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Trial ID | NCT06720909 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and acceptability of a three-arm randomized-controlled trial that combines mindfulness-based therapy (MBSR) and open-label placebo (OLP) treatment for individuals suffering from chronic pain. Participants will be randomly assigned to one of three groups: MBSR, OLP, or a combination of both treatments. The trial lasts for 8 weeks, followed by a 3-month post-treatment follow-up to assess outcomes. The goal is to determine how these interventions can help manage chronic pain effectively.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who experience chronic pain on at least half of the days over the past three months.
Not a fit: Patients with acute pain, chronic malignant pain, or severe psychopathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-pharmacological option for managing chronic pain.
How similar studies have performed: Other studies have shown promise in using mindfulness and placebo approaches for pain management, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 1 other locations
- Arizona State University Downtown Phoenix Campus — Phoenix, Arizona, United States (RECRUITING)
- Arizona State University — Phoenix, Arizona, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Chung Jung Mun, PhD — Arizona State University
- Study coordinator: Chung Jung Mun, PhD
- Email: chungjung.mun@asu.edu
- Phone: 602-496-0809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pain, chronic pain, pain, mindfulness, placebo