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

Mass General Brigham

Status: Completed

Conditions: Musculoskeletal Pain; Chronic Pain

Treatments: Behavioral: GetActive+

Study type: Interventional

Funder types: Other

Identifiers

NCT05782231

2023P000362

Details and patient eligibility

About

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/).

Full description

The aim of this phase is to establish feasibility (primary), acceptability, and fidelity of GetActive+ and study procedures in an open pilot (N=30). Deliverables: GetActive+ will be feasible (≥75% agree to participate), acceptable (≥75% of those enrolled will complete 8/10 sessions) and delivered with fidelity (≥75% sessions delivered as intended).

Our patients will be older adults with chronic pain from Revere HealthCare Center.

The GetActive+ program will incorporate mind-body skills, cognitive behavioral and physical restoration skills (e.g., quota-based pacing) to help individuals increase self-reported, performance based and objective (step count) physical function. This program will teach participants four core skills: 1) weekly goal setting for gradual increase in time spent walking paired with activities of daily living that are meaningful and important to participants (i.e. walk instead of drive to the store; walk to the park with kids) 2) quota-based pacing (increasing walking goal gradually non-contingent of pain); 3) mind-body skills (e.g., diaphragmatic breathing to manage intense pain flares and pain anxiety; body scan to increase body awareness and reduce reactivity to pain sensations; mindfulness exercises to understand the transience of pain and change one's relationship with it; self-compassion when falling short of set goals); and 4) understand the downward spiral (e.g. how reducing activity perpetuates pain and disability), correct myths about pain or unhelpful pain-related thoughts that interfere with meeting program goals. Participants will be encouraged to complete their homework (logs for mind-body practice, physical activities) each day. Participants will be given the option to receive homework and session reminders via text messages from study staff. This between session contact will focus on increasing treatment adherence, maintaining engagement, and session reminders. The investigators will run groups primarily in English with an additional two groups in Spanish.

Baseline assessments and post-intervention assessments will include the six-minute walk test (6MWT), objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness.

Enrollment: 33 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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. No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study
6. Ability to complete the 6-minute walk test under supervision of study staff
7. Patient at Revere HealthCare Center who is cleared for participation by medical staff
8. English or Spanish fluency

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 wear the ActiGraph device

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

GetActive+

Experimental group

Description:

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

Treatment:

Behavioral: GetActive+