Improving Health for Older Adults With Pain Through Engagement (Open-pilot)

NCT05782231 | Completed Results DMC

• 1 other identifier: 2023P000362
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to conduct an open-pilot (N=30) to evaluate the feasibility, acceptability, and fidelity of a mind-body and activity program (GetActive+) with older adults with chronic pain. 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 and post-intervention. This study received 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; Community health center; Physical function

Outcome Measures

Primary Outcomes (3)

• Feasibility of Intervention Completion

  \>=75 of patients approached agree to participate in intervention

  10 weeks

• Acceptability

  \>=75% of enrolled participants complete at least 8/10 sessions

  10 weeks

• Fidelity of Session Components, As Rated by Clinicians

  Clinician raters, with experience in intervention refinement or delivery, randomly selected 20% of all sessions to rate their components for this outcome. All sessions were audio-recorded. The overall number of units analyzed, which is reported below, refers to that 20% of the total number of sessions that were then analyzed for this outcome); the overall number of participants analyzed, which is also reported below, is the total number of participants in this study. Clinician raters used fidelity checklists to guide their ratings of the different session components. A session component was considered delivered as intended if the rater provided a score ≥8 (the scale was 1=poor to 10=outstanding). Reported here are the number of session components with a score ≥8, indicating successful delivery; the percentage of the total analyzed sessions that this represents is also calculated out below. The study benchmark we looked to meet for this fidelity measure was 75%.

  Fidelity, as described above, was assessed periodically throughout the 11 months of the study, and is presented here as the sum total counts of all the high scoring components (again, described above) that were assessed over this 11 month time period.

Secondary Outcomes (24)

• Physical Function - Performance-based

  Baseline (0 weeks), Post-test (1 week after intervention completion)

• Physical Function - Objective

  Baseline (0 weeks), Post-test (1 week after intervention completion)

• Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales

  Baseline (0 weeks), Post-test (1 week after intervention completion)

• Patient Health Questionnaire-8 (PHQ-8)

  Baseline (0 weeks), Post-test (1 week after intervention completion)

• Generalized Anxiety Disorder Scale-7 (GAD-7);

  Baseline (0 weeks), Post-test (1 week after intervention completion)

Other Outcomes (1)

• Qualitative Assessment of Intervention by Participants

  Post-test (1 week after intervention completion)

Study Arms (1)

GetActive+

EXPERIMENTAL

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

Behavioral: GetActive+

Interventions

GetActive+ BEHAVIORAL

10-week group mind body program focused on improving self-report, performance-based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased 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)
• No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study
• Ability to complete the 6-minute walk test under supervision of study staff
• Patient at Revere HealthCare Center who is cleared for participation by medical staff
• English or Spanish fluency

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 wear the ActiGraph device

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

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

• McDermott K, Levey N, Brewer J, Ehmann M, Hooker JE, Pasinski R, Yousif N, Raju V, Gholston M, Greenberg J, Ritchie CS, Vranceanu AM. Improving Health for Older Adults With Pain Through Engagement: Protocol for Tailoring and Open Pilot Testing of a Mind-Body Activity Program Delivered Within Shared Medical Visits in an Underserved Community Clinic. JMIR Res Protoc. 2023 Dec 29;12:e52117. doi: 10.2196/52117.

  PMID: 38157234 BACKGROUND

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

Results Point of Contact

• Title: Ana-Maria Vranceanu, PhD
• Organization: Massachusetts General Hospital

avranceanu@mgh.harvard.edu

617-724-4977

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 23, 2023
• Study Start: April 18, 2023
• Primary Completion: December 12, 2023
• Study Completion: March 5, 2024
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data is currently available in the repository.
• Access Criteria: No specialized tools will be needed to access the data other than what is noted on the Vivli website.

Locations

US (1)