N/A
N=92
The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT05700383 ↗Enrolled (actual)
92
Serious AEs
7.6%
Results posted
Jul 2025
Primary outcome: Primary: Recruitment Feasibility (Ability) — 92 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GetActive-Fitbit (Behavioral); Healthy Living for Pain (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility (Ability) |
92 | — |
| PRIMARY Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year |
92 | — |
| PRIMARY Feasibility of Recruitment Racial and Ethnic Minorities |
50 | — |
| PRIMARY Intervention Feasibility/ Adherence to Sessions |
44; 37; 2; 8 | — |
| PRIMARY Credibility and Expectancy Scale - Credibility |
41; 34; 0; 5 | — |
| PRIMARY Client Satisfaction Scale |
41; 30; 1; 10 | — |
| PRIMARY Retention |
44; 39; 3; 6; 41; 37 | — |
| PRIMARY Assessment Feasibility |
3241 | — |
| PRIMARY Credibility and Expectancy Questionnaire - Expectancy |
36; 26; 6; 13 | — |
| SECONDARY Pain, Enjoyment of Life and General Activity (PEG-3) Scale |
6.36; 6.72; 5.05; 5.89; 4.61; 5.27 | — |
| SECONDARY WHO Disability Assessment Schedule 2.0 (WHODAS) |
48.79; 44.86; 35.21; 39.24; 34.61; 36.93 | — |
| SECONDARY 6 Minute Walk Test (6MWT) |
289.62; 260.28; 339.20; 307.37; 316.71; 299.74 | — |
| SECONDARY ActiGraph GT9X |
2641.43; 3177.11; 3694.77; 3032.90; 3050.62; 3290.56 | — |
| SECONDARY PROMIS Depression v1.08b |
54.67; 54; 52.81; 52.14; 52.59; 52.82 | — |
| SECONDARY PROMIS Anxiety v1.08a |
57.25; 56.24; 55.04; 54.69; 53.67; 53.12 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
20.47; 19.71; 11.70; 16.77; 12.57; 16.20 | — |
| SECONDARY Tampa Kinesiophobia Scale (TSK) |
39.98; 40.37; 34.88; 40.13; 34.94; 39.20 | — |
| SECONDARY Measure of Current Status (MOCS) |
2.27; 2.27; 2.50; 2.37; 2.51; 2.57 | — |
| SECONDARY Cognitive and Affective Mindfulness Scale (CAMS) |
32.11; 34.43; 34.33; 34.32; 32.96; 35.46 | — |
| SECONDARY Modified Global Impression of Change (MGIC) |
6.20; 5.38; 5.93; 5.15; 6.00; 5.40 | — |
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.
Eligibility Criteria
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)
- Sitting for more than 8 hours/day per self-report
- Exercising for fewer than 3 days/week (30+min of exercise constitutes an "exercise day") per self-report
- 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).
Data sourced from ClinicalTrials.gov (NCT05700383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.