This Project is a Three-arm RCT Evaluating Two, Single-session Behavioral Interventions for Adults With Chronic Musculoskeletal Pain (CMP) -- 1) Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) vs. Empowered Relief (ER) -- Relative to the Traditional 8-week Version of MORE.
- Conditions
- Chronic Musculoskeletal Pain
- Registration Number
- NCT07193095
- Lead Sponsor
- Florida State University
- Brief Summary
Researchers at Florida State University are investigating how the length of treatment influences outcomes for individuals with chronic musculoskeletal pain. The goal is to identify the most effective balance between treatment duration and pain relief. There are three treatment conditions in this study: two different brief pain management trainings and one standard-length training. Participants will be randomized to either of the brief trainings, attending a single, 2-hour, online training session, in which a trained facilitator will teach pain management techniques that are backed by research. If randomized to receive the standard-length training, participants will attend eight, 2-hour, online training session over eight weeks, in which a trained facilitator will also teach research-backed pain management techniques. Short surveys will be required at seven different time points: before starting treatment, immediately after the pain-management training, and then 2, 6, 12, 24, and 36 weeks after the training.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 39
- (1) having a chronic musculoskeletal pain condition, (2) average pain of ≥ 3 in the previous week, (3) willingness to engage with study assessments and interventions, (4) understanding English instructions fluently, and (5) being 18 and above.
- (1) unable to consent because of physical or mental incapacity, (2) have previous, formal mindfulness training (e.g., MBSR) or previously receiving Empowered Relief, (3) have pain from a current cancer diagnosis or cancer-related treatment, (4) unstable illness that may interfere with treatment, (5) had surgery within the previous three months, and (6) had pain relieving injections, such as cortisone or hyaluronate, within the previous three months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recruitment Feasibility 6 months Recruitment feasibility will be assessed via total enrollment and randomization numbers within the first 6 months of the study. Study team projects that it will be feasible to recruit and randomize 30 adults with CMP within 6 months.
Treatment Adherence & Acceptability From baseline to 9-month follow-up Adherence (percentage of total treatment time attended) will be better for the single-session interventions, but all three conditions will be rated as highly acceptable (as measured by the Theoretical Framework of Acceptability; TFA).
- Secondary Outcome Measures
Name Time Method PROMIS - Pain Intensity From baseline to 9-month follow-up A 3-item questionnaire using a 5-point Likert-like scale (1- had no pain to 5- very severe). Questions include "In the past 7 days, How intense was your pain at its worst?"
PROMIS - Pain Interference From baseline to 9-month follow-up An 8-item questionnaire using a 5-point Likert-like scale (1- not at all to 5- very much). Questions include "In the past 7 days, how much did pain interfere with work around the home?".
Trial Locations
- Locations (1)
Research Building B
🇺🇸Tallahassee, Florida, United States
Research Building B🇺🇸Tallahassee, Florida, United States
