Recruiting

GetActive+ vs. TAU

Sponsor:

Massachusetts General Hospital

Code:

NCT06119698

Conditions

Chronic Pain

Musculoskeletal Pain

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

GetActive+

Study Details

Brief summary:

The goal of this project is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of a 10-week mind-body and walking program (GetActive+) vs treatment as usual (TAU). The investigators will test for improvements in self-reported, performance-based (i.e., six-minute walk test), and objective (i.e., step-count) physical function, emotional function, as well as feasibility, acceptability and implementation markers. Participants will complete measures at baseline (0 weeks), post-intervention (1 week after intervention completion), and 6-month follow-up.

This study will receive support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).

Conditions

Chronic Pain

Musculoskeletal Pain

Study ID

NCT06119698

Start date

Oct 1, 2024

Status verified date

Nov, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GetActive+

A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain

no intervention: Treatment as usual

Treatment as Usual (TAU) includes traditional primary care management of chronic pain.

Interventions

GetActive+

This is a 10-week group mind body program focused on improving self-reported physical activity, performance-based physical activity, and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increase in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.

Primary outcome measure

  • Physical function - self-report [ Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome. ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • Older adults
  • Mind-body intervention
  • Chronic pain
  • ActiGraph
  • Community health center
  • Physical function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-18.