Mind-body and walking program for older adults with chronic pain
Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ vs Treatment as Usual; iHOPE Study
This study tests if a 10-week mind-body and walking program can help older adults with chronic pain feel better compared to their usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06119698 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness and implementation of a 10-week mind-body and walking program called GetActive+ compared to treatment as usual for older adults with chronic pain. The study will involve 200 participants who will be assessed on their physical and emotional function through self-reported measures, performance-based tests, and objective step counts at multiple time points. The program incorporates skills such as goal setting, pacing, and mind-body techniques to enhance physical activity and overall well-being. Data will be collected at baseline, post-intervention, and at a 6-month follow-up to determine the program's feasibility and acceptability.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 55 and above with a diagnosis of musculoskeletal chronic pain and a moderate pain score.
Not a fit: Patients with serious medical illnesses expected to worsen, or those with untreated psychotic or substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve physical and emotional well-being for older adults suffering from chronic pain.
How similar studies have performed: Other studies have shown promise with mind-body interventions for chronic pain, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Older Adults (i.e., age \>=55) 2. Diagnosed musculoskeletal chronic pain of any type (e.g., pain \> 3 months) 3. Pain score \>=4 (moderate) on the Numerical Rating Scale 4. Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., \<4 errors) 5. Self-reported ability to complete the 6-minute walk test including with assistive devices 6. Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff 7. English or Spanish fluency and literacy Exclusion Criteria: 1. Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer) 2. Individuals who are unwilling or unable to comply with study procedures including wearing a smartwatch 3. Active suicidal ideation with plan or intent 4. Active and untreated serious mental health or substance use disorder
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ana-Maria Vranceanu, PhD — Massachusetts General Hospital
- Study coordinator: Ana-Maria Vranceanu, PhD
- Email: avranceanu@mgh.harvard.edu
- Phone: 617-724-4977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.