Trial Summary
What is the purpose of this trial?
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
Adults over 18 with chronic musculoskeletal pain, low activity levels, and the ability to walk can join this study. They must be fluent in English, own a smartphone or computer, and either not take psychotropic meds or have been stable on them for 6 weeks. Excluded are those with serious mental illness, substance abuse issues, regular mind-body practice users, severe medical conditions expected to worsen soon, suicidal thoughts or certain cognitive impairments.Inclusion Criteria
Owns a smartphone with Bluetooth 4.0 or computer
I am willing and able to follow the study's requirements.
I am not very active, meeting 2 out of 3 low activity criteria.
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Exclusion Criteria
My doctor expects my illness to get worse in the next 6 months.
I am unable to walk and use a wheelchair.
You have been using a Fitbit DMD regularly for the past 3 months.
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Treatment Details
Interventions
- GetActive with Steps! (Behavioural Intervention)
- Healthy Living for Pain (Behavioural Intervention)
Trial OverviewThe trial is testing two programs: a 'mind-body walking program' using GetActive-Fitbit versus a 'health education program' called Healthy Living for Pain. The goal is to see which one works better for people with chronic pain. Participants will be randomly placed into one of these two groups.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: GetActive-FitbitExperimental Treatment1 Intervention
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.
Group II: Healthy Living for PainActive Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke UniversityDurham, NC
Rush Medical CenterChicago, IL
Massachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
Rush University Medical CenterCollaborator
Duke UniversityCollaborator
National Center for Complementary and Integrative Health (NCCIH)Collaborator