The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program compared to a health education program for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person.
The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program (GetActive-Fitbit) compared to a health education program (Healthy Living for Pain) for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person. Each program will consist of ten 60-minute sessions in-person. Participants will receive a treatment manual and ActiGraph watch to assess physical function. There are 3 assessment points consisting of self-report surveys and performance-based measures: baseline, post-program, and 6-month follow-up. All participants will receive access to the other program's manual and website after completing the six-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking.
Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling.
Rush Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
Recruitment Feasibility (Ability)
Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
Time frame: 1 Year
Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year
Timeliness of enrollment; we will recruit a sample of 90 patients across the 3 sites over the course of 1 year. Participants will be considered enrolled upon randomization. Assessed by the number of participants enrolled in the study over the course of 1 year. If number enrolled meets or exceeds goal of 90 participants, the benchmark is considered met.
Time frame: 1 Year
Feasibility of Recruitment Racial and Ethnic Minorities
38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution.
Time frame: 1 Year
Intervention Feasibility/ Adherence to Sessions
≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
Time frame: Post-Test (10 Weeks)
Credibility and Expectancy Scale - Credibility
≥80 chronic pain patients with credibility scores higher than the Credibility and Expectancy Scale credibility subscale's mid-point, indicating intervention credibility. Credibility subscale scores range from 3 to 27. Higher scores indicate higher perceived credibility for the program.
Time frame: Baseline (0 Weeks)
Client Satisfaction Scale
≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction.
Time frame: Post-Test (10 Weeks)
Retention
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≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants).
Time frame: Post-test (10 weeks), Follow-up (24 weeks)
Assessment Feasibility
We calculated the proportion of assessment procedures that were administered as intended in the the checklists of the study protocol. The number of assessment procedures that were administered in line with the study's protocol checklists was divided by the total number of assessment procedures. The benchmark was set to 90%, i.e., assessment procedures were deemed feasible if ≥90% of assessment procedures were delivered as specified in the protocol.
Time frame: 1 Year
Credibility and Expectancy Questionnaire - Expectancy
≥80 chronic pain patients with expectancy scores higher than the subscale's mid-point, indicating intervention expectancy. Expectancy subscale scores range from 3 to 27. Higher scores indicate more belief that treatment will help.
Time frame: Baseline (0 weeks)
Pain, Enjoyment of Life and General Activity (PEG-3) Scale
Rate of a participant's pain intensity and related interference in enjoyment of life and general activity, using a 0-10 Likert scale. Scores range from 0-30 with higher scores indicating greater pain and interference.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
WHO Disability Assessment Schedule 2.0 (WHODAS)
The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each question on the scale is measured 0-4. The score range is 0-100, with higher scores indicating more disability.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
6 Minute Walk Test (6MWT)
The 6MWT is a performance-based measure that assesses physical function and endurance.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
ActiGraph GT9X
The ActiGraph GT9X is a step count device that objectively measures function (number of steps).
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
PROMIS Depression v1.08b
The PROMIS depression v1.08b measures negative mood, views of self and cognitions on a 5-point scale. Raw scores are converted into a t-score with a mean of 50 and standard deviation of 10. Higher scores indicate more depressive symptoms.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
PROMIS Anxiety v1.08a
The PROMIS anxiety v1.08a measures fear, worry, hyperarousal and somatic symptoms. Each item is rated on a 1-5 point Likert Scale and raw scores are converted to t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicating more anxiety symptoms.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Pain Catastrophizing Scale (PCS)
A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Higher scores indicate higher pain catastrophizing. Scores range from 0 to 52.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Tampa Kinesiophobia Scale (TSK)
A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia. Scores range from 17 to 68.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Measure of Current Status (MOCS)
The MOCS questionnaire assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Higher scores indicate a stronger ability to recognize stress and cope, with scores ranging from 10 to 50.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Cognitive and Affective Mindfulness Scale (CAMS)
Rate of a participant's broad conceptualization of mindfulness, items range from 1-4. Higher values reflect higher levels of mindfulness. Scores range from 12 to 48.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Modified Global Impression of Change (MGIC)
3-items assessing the extent to which patients perceive the intervention improved functioning and symptoms. Each item is rated on a 1-7 point scale with higher scores indicated greater perceived improvement.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)