The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain

Not Applicable

Completed

Conditions: Chronic Pain

Registration Number: NCT05700383

Lead Sponsor: Massachusetts General Hospital

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

Inclusion Criteria

Male and female outpatients, age 18 years or older
Fluent in English
Have nonmalignant chronic musculoskeletal pain for more than 3 months
Able to perform a 6-minute walk test (6MWT)
Owns a smartphone with Bluetooth 4.0 or computer
Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol.
Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
Low-level of activity (must meet 2/3 criteria; if difficult to assess, recruiter may ask participant to report their recent step data from their smartphone to better understand their activity level)
1. Sitting for more than 8 hours/day per self-report
2. Exercising for fewer than 3 days/week (30+min of exercise constitutes an "exercise day") per self-report
3. Walking for fewer than 7 days/week (30+min of walking constitutes a "walking day") per self-report

Exclusion Criteria

Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
Serious mental illness or instability for which hospitalization may be likely in the next 6 months
Current active suicidal ideation reported on self-report
Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder
Current, active substance abuse or dependence, and current alcohol dependence within the past 6 months
Practice of yoga, meditation, guided imagery or other mind body techniques that elicit the RR, once per week for >45 min 3 times/week within the last 3 months or less.
Regular use of Fitbit DMD in the last 3 months
Unable to walk/in a wheelchair
Mild cognitive decline for participants 65+ only (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment Feasibility (Ability)	1 Year	Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year	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.
Feasibility of Recruitment Racial and Ethnic Minorities	1 Year	38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution.
Intervention Feasibility/ Adherence to Sessions	Post-Test (10 Weeks)	≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
Credibility and Expectancy Scale - Credibility	Baseline (0 Weeks)	≥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.
Client Satisfaction Scale	Post-Test (10 Weeks)	≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction.
Retention	Post-test (10 weeks), Follow-up (24 weeks)	≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants).
Assessment Feasibility	1 Year	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.
Credibility and Expectancy Questionnaire - Expectancy	Baseline (0 weeks)	≥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.

Secondary Outcome Measures

Name	Time	Method
6 Minute Walk Test (6MWT)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	The 6MWT is a performance-based measure that assesses physical function and endurance.
ActiGraph GT9X	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	The ActiGraph GT9X is a step count device that objectively measures function (number of steps).
PROMIS Depression v1.08b	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
PROMIS Anxiety v1.08a	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
Pain Catastrophizing Scale (PCS)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
Pain, Enjoyment of Life and General Activity (PEG-3) Scale	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
WHO Disability Assessment Schedule 2.0 (WHODAS)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
Tampa Kinesiophobia Scale (TSK)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia. Scores range from 17 to 68.
Measure of Current Status (MOCS)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
Cognitive and Affective Mindfulness Scale (CAMS)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.
Modified Global Impression of Change (MGIC)	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)	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.

Trial Locations

Locations (3): Rush Medical Center
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Duke University
🇺🇸
Durham, North Carolina, United States
Rush Medical Center
🇺🇸Chicago, Illinois, United States