Clinical trial NCT06119698: Improving Health for Older Adults with Pain Through Engagement
Official title: Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ Vs Treatment As Usual; IHOPE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Keywords: Older adults
Mind-body intervention
Chronic pain
ActiGraph
Community health center
Physical function
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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/).

Detailed description: The aim of this phase is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of GetActive+ vs TAU on the following outcomes.

Aim 1: Self- reported physical function at 10 weeks (primary). Aim 2: Self-reported physical function at 6 months, performance based (6-minute walk test), and objective (step-count) physical function, as well as self-reported emotional function, pain, social support and loneliness at 10 weeks and 6 months.

Aim 3: Feasibility, acceptability, fidelity and adoption at patient, provider, and organization levels based on Proctor's implementation framework using mixed methods.

The investigators will enroll N=200 older adults with chronic pain from Revere HealthCare Center and MGH Broadway Primary Care in Revere

The GetActive + program used in the Randomized Controlled Trial (RCT) 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; progressive muscle relaxation 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 automatic 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 additional groups in Spanish.

Baseline assessments, post-intervention assessments and 6-month follow up assessments will include the 6MWT, objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness, while accounting for clinical, demographic, and social determinants of health.

Eligibility 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. No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study
6. Self-reported ability to complete the 6-minute walk test
7. Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff
8. English fluency 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
3. Active suicidality

Primary outcomes:
measure: Physical function - self-report
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome.
Secondary outcomes:
measure: Physical function - performance-based
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Physical function - objective
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Pain Intensity
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Depression
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Anxiety
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Pain Catastrophizing
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Pain Intensity and Interference
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Mindfulness
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Acceptability of Intervention Sessions
timeFrame: Post-Intervention
measure: Fidelity of Session Delivery
timeFrame: 120 weeks
measure: Adoption of Intervention
timeFrame: 120 weeks
measure: Feasibility of Intervention Recruitment
timeFrame: 120 weeks
Other outcomes:
measure: Loneliness
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Social Support
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Stress
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Post Traumatic Stress Disorder
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Emotional Function
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Impression of Change in Pain
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Fear of Pain
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Self-Compassion
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Substance Use
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Current Status
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Discrimination
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Sleep Disturbance
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
measure: Sleep Quality
timeFrame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Christine Ritchie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.