Effectiveness and Implementation Trial of GetActive Mind-Body Program Versus Usual Care for Older Adults with Chronic Musculoskeletal Pain
Led by Massachusetts General Hospital · Updated on 2025-11-18
200
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and implementation of a 10-week mind-body and walking program called GetActive compared to treatment as usual TAU in older adults with chronic musculoskeletal pain. This randomized, hybrid type 1 trial aims to improve physical function, emotional function, and assess feasibility and acceptability of the program. The study will enroll 200 participants and measure outcomes at baseline, one week after the intervention, and at six months follow-up.
The GetActive program combines mind-body skills like diaphragmatic breathing, progressive muscle relaxation, mindfulness, and self-compassion with gradual walking goal setting using quota-based pacing. Participants will attend group sessions primarily in English, with some in Spanish, and receive homework assignments with optional text reminders to support adherence. The comparison group will receive their usual primary care management for chronic pain.
Participants will complete assessments including a six-minute walk test, objective step counts using ActiGraph devices, and self-reported measures of physical function, emotional function, pain, social support, and loneliness at three time points. Researchers will also monitor program feasibility, acceptability, and implementation at patient, provider, and organizational levels. The total study duration is approximately nine months, covering baseline, post-intervention, and follow-up evaluations.
CONDITIONS
Brief Title
Improving Health for Older Adults With Pain Through Engagement
Research Team
A
Ana-Maria Vranceanu, PhD
C
Christine Ritchie, MD, MPH
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
GetActive+ Mind Body Activity Program
Treatment as Usual (Routine Care)
What it is
A 10-week group mind body activity program specifically designed for older adults with chronic musculoskeletal pain. The program combines mind body skills and quota-based pacing to encourage increased physical activity and walking, using goal setting and gradual activity increases within a supportive group format.
Continued routine medical care without participation in the group program. Participants receive standard care and management for chronic pain according to usual practices, with no additional behavioral, mind body, or activity group intervention from the study.
Role in the trial
Serves as the experimental intervention arm. Participants are randomly assigned to engage in the GetActive+ mind body activity program during the study period.
Acts as the comparator control arm. Participants continue with their normal care to measure effects relative to routine management without additional behavioral intervention.
Primary use
Designed to increase physical activity, improve pain coping, and enhance functional outcomes for older adults experiencing chronic musculoskeletal pain. The program aims to help participants develop mind body skills and set walking goals tailored to individual abilities.
Provides standard medical care for chronic pain as delivered by primary care providers without additional mind body or activity group support. No new intervention from the study is offered.
How it is given or performed
Participants take part in weekly group sessions for 10 weeks, practicing mind body skills, goal setting, and quota-based walking. Sessions are tailored for older adults and include gradual increase of physical activity.
Participants continue their usual medical care with no special study visits or additional sessions. No study behavioral intervention is performed.
Evidence status
Evidence from earlier mind body activity programs suggests positive effects on physical activity and pain coping in adults with chronic pain, with improvements in physical and emotional function. The program structure is adapted for older adults. This trial is designed to establish effectiveness in this population.
Routine care for chronic pain often relies on medical management and physical activity advice, but does not consistently provide structured mind body group programs. Published evidence supports multi-modal approaches, but routine care alone may not deliver the same level of activity support as specialized programs.
Important limitations
Requires participant engagement in group sessions and ability to attend regularly for 10 weeks. Some older adults may face barriers such as transportation or mobility limits. Evidence to date is mostly qualitative or case-based; effectiveness for older adults in underserved areas still requires confirmation.
Routine care may lack structured behavioral intervention and tailored activity support found in group programs. Standard care does not provide consistent group-based mind body skills or goal setting for physical activity.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 55Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age 55 years or older
Diagnosed with musculoskeletal chronic pain lasting more than 3 months
Moderate pain score of 4 or higher on the Numerical Rating Scale
Cognitively able to participate with less than 4 errors on the Short Portable Mental Health questionnaire
Able to complete a six-minute walk test, with or without assistive devices
Patient at Revere HealthCare Center or MGH Broadway Primary Care cleared by medical staff
Fluent and literate in English or Spanish
You will not qualify if you...
Serious medical illness expected to worsen within 6 months (e.g., cancer)
Unwilling or unable to follow study procedures, including wearing a smartwatch
Active suicidal thoughts with plan or intent
Untreated serious mental health or substance use disorder
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 10 weeks
Participants in the GetActive+ group attend a 10-week group mind-body program focused on improving physical and emotional function through mind-body skills and gradual walking increase. Participants in the Treatment as Usual group receive traditional primary care management for chronic pain.
Weekly group sessions
Follow-up
Duration - Approximately 9 months total from baseline
Participants complete post-intervention assessments and a 6-month follow-up to evaluate physical function, pain, emotional function, and social support.
Baseline, post-intervention, and 6-month follow-up visits
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study.
Clara Vonderheide, Courtney Kilduff, Katherine A McDermott...