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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brief Mindfulness Oriented Recovery Enhancement

    Behavioral

    B-MORE is a 2-hour, single session adaptation of the traditional MORE program.

  • Empowered Relief

    Behavioral

    ER is an evidence-based 2-hour single session intervention for chronic pain.

  • Mindfulness Oriented Recovery Enhancement

    Behavioral

    MORE is an 8-week evidence-based treatment for chronic pain.

Treatment groups

39 Participants
are divided into 3 treatment groups
Group A: Brief Mindfulness Oriented Recovery Enhancement (B-MORE)Experimental treatment 1 intervention
Group B: Empowered Relief (ER)Experimental treatment 1 intervention
Group C: Mindfulness Oriented Recovery Enhancement (MORE)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Feasibility

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.

Time frame
6 months
2

Treatment Adherence & Acceptability

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).

Time frame
From baseline to 9-month follow-up

Secondary outcomes

1

PROMIS - Pain Intensity

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?"

Time frame
From baseline to 9-month follow-up
2

PROMIS - Pain Interference

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?".

Time frame
From baseline to 9-month follow-up

Other outcomes

1

PROMIS - Depression

A 4-item questionnaire using a 5-point Likert-like scale (1- never to 5- very much). Statements include "In the past 7 days, I felt worthless."

Time frame
From baseline to 9-month follow-up
2

PROMIS - Anxiety

A 4-item questionnaire using a 5-point Likert-like scale (1- never to 5- almost always). Statements include "In the past 7 days, my worries overwhelmed me".

Time frame
From baseline to 9-month follow-up
3

PROMIS - Sleep Disturbance

A 6-item questionnaire using a 5-point Likert scale

Time frame
From baseline to 9-month follow-up
4

World Health Organization - Quality of Life

A 2-question assessment to measure self-reported quality of life. Participants will be asked "How would you rate your quality of life?" with a 5-point Likert scale (with "1- very poor" to "5-very good"). Participants will also be asked "How satisfied are you with your health?" with a 5-point Likert like scale (with "1-very dissatisfied" to "5-very satisfied").

Time frame
From baseline to 9-month follow-up.

Sponsors and contacts

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