Improving Health for Older Adults With Pain Through Engagement

NCT06119698 | Recruiting

• 1 other identifier: 2024P000782
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Physical function - self-report

  Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 Physical Functioning Short Form 6b; assesses ability to carry out activities that require physical actions, ranging from self-care to work. Scores range from 6 to 30, with higher scores indicating greater physical function.

  Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome.

Secondary Outcomes (7)

• Physical function - objective

  Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)

• Physical function - performance-based

  Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)

• Pain Intensity and Severity

  Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)

• Pain Intensity and Interference

  Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)

• Depression

  Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)

Other Outcomes (16)

• Quota-based Pacing

  Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)

• Pain Catastrophizing

  Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)

• Mindfulness

  Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)

Study Arms (2)

GetActive+

EXPERIMENTAL

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

Behavioral: GetActive+

Treatment as usual

NO INTERVENTION

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

Interventions

GetActive+ BEHAVIORAL

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.

GetActive+

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older Adults (i.e., age \>=55)
• Diagnosed musculoskeletal chronic pain of any type (e.g., pain \> 3 months)
• Pain score \>=4 (moderate) on the Numerical Rating Scale
• Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., \<4 errors)
• Self-reported ability to complete the 6-minute walk test including with assistive devices
• Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff
• English or Spanish fluency and literacy

You may not qualify if:

• Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer)
• Individuals who are unwilling or unable to comply with study procedures including wearing a smartwatch
• Active suicidal ideation with plan or intent
• Active and untreated serious mental health or substance use disorder

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (4)

• Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007/s10880-020-09758-w. Epub 2021 Jan 19.

  PMID: 33469845 BACKGROUND

• Grunberg VA, Greenberg J, Mace RA, Bakhshaie J, Choi KW, Vranceanu AM. Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. J Pain. 2022 Nov;23(11):1933-1944. doi: 10.1016/j.jpain.2022.07.003. Epub 2022 Jul 29.

  PMID: 35914640 BACKGROUND

• Popok PJ, Greenberg J, Gates MV, Vranceanu AM. A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. Complement Ther Clin Pract. 2021 Aug;44:101410. doi: 10.1016/j.ctcp.2021.101410. Epub 2021 May 2.

  PMID: 33971485 BACKGROUND

• Vonderheide C, Kilduff C, McDermott KA, Greenberg J, La Camera DE, Giraldo-Santiago N, Kurkul A, Alvarez-Frank N, Kim Y, Pasinski R, Gholston M; iHOPE Study Team; Ritchie CS, Vranceanu AM. 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. Contemp Clin Trials. 2025 Dec;159:108116. doi: 10.1016/j.cct.2025.108116. Epub 2025 Oct 24.

  PMID: 41326265 DERIVED

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Christine Ritchie, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana-Maria Vranceanu, PhD

CONTACT

617-724-4977; avranceanu@mgh.harvard.edu

Christine Ritchie, MD, MPH

CONTACT

617-726-1382; csritchie@mgh.harvard.edu,

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 7, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Information is anticipated to be available 6 months after completion of the study.
• Access Criteria: Data can be accessed in the Vivli data repository; no specialized tools will be need to view the data other than what is noted on the Vivli website. See above for details on what will be available to access.

Locations

US (1)