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Recruiting NCT07193095

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.

No phase Interventional Chronic Musculoskeletal Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief Mindfulness Oriented Recovery Enhancement, Empowered Relief, Mindfulness Oriented Recovery Enhancement.
Who it may be relevant to
Registry conditions: Chronic Musculoskeletal Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Brief MORE: A Mindfulness Intervention For Chronic Musculoskeletal Pain

Overview

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.

Interventions

  • Behavioral Brief Mindfulness Oriented Recovery Enhancement
    B-MORE is a 2-hour, single session adaptation of the traditional MORE program.
  • Behavioral Empowered Relief
    ER is an evidence-based 2-hour single session intervention for chronic pain.
  • Behavioral Mindfulness Oriented Recovery Enhancement
    MORE is an 8-week evidence-based treatment for chronic pain.

Primary outcome measures

  • Recruitment Feasibility [Time frame: 6 months]
  • Treatment Adherence & Acceptability [Time frame: From baseline to 9-month follow-up]
Secondary outcome measures (2)
  • PROMIS - Pain Intensity [Time frame: From baseline to 9-month follow-up]
  • PROMIS - Pain Interference [Time frame: From baseline to 9-month follow-up]

Eligibility criteria

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Research Building B — Tallahassee

Identifiers

NCT: NCT07193095 · 00006036

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗