About this trial
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
Qualifiers
≥18 years old;
ability to speak, write, and read in English;
physical pain present on at least half the days in the past 3 months; and
average past week pain severity rating ≥3 on a 0-10 Numerical Rating Scale.
Disqualifiers
acute pain due to recent injury or surgery;
self-reporting of chronic malignant pain (e.g., cancer, HIV);
self-reporting of Raynaud's disease (those who can be contraindicated for cold pressor testing);
severe psychopathology (e.g., a psychotic disorder) or significant cognitive deficits judged to interfere with study procedures;
Trial design
Treatments tested in this trial
- Mindfulness-Based Stress Reduction (MBSR)
- Open-Label Placebo (OLP)
- MBSR+OLP
Treatment groups
Sponsors and collaborators
Arizona State University
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator