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NCT Number: NCT06119698

Improving Health for Older Adults With Pain Through Engagement

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/).

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Key information

Conditions

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

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

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 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. Physical function - objective

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

    Average step count with wrist-worn ActiGraph wGT3X-BT; collects average step count for 4-7 days.

  2. Physical function - performance-based

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

    6-minute walk test (6MWT); measures the total distance in meters covered by an individual in 6 minutes, with greater distances covered indicating better physical function.

  3. Pain Intensity and Severity

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

    Brief Pain Inventory - Short Form (BPI-SF); assesses pain severity and interference. Scores range from 0 to 10, with higher scores indicating more severe pain severity or interference.

  4. Pain Intensity and Interference

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

    Pain, Enjoyment of Life and General Activity (PEG) Scale; measures pain intensity and pain interference in the enjoyment of life and activities of daily living. Scores range from 0 to 10, with higher scores indicating more severe pain and related interference.

  5. Depression

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

    Patient Health Questionnaire - 8 (PHQ-8); assesses depressive symptoms. Scores range from 0 to 24, with higher scores indicating more severe depressive symptoms.

  6. Anxiety

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

    Generalized Anxiety Disorder - 7 (GAD-7); measures anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety.

  7. Impression of Change

    Time frame: Post-Intervention

    Patient Global Impression of Change (PGIC); assesses subjective changes in response to the intervention. Scores range from 0 to 6, with higher scores indicating worse outcomes.

Other outcomes

  1. Quota-based Pacing

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

    4-item subsection of the Activity Pacing Questionnaire; measures ability to pace. Scores range from 4 to 20, with higher scores indicating increased quota-based pacing.

  2. Pain Catastrophizing

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

    Pain Catastrophizing Scale (PCS); assesses magnification, helplessness, and rumination associated with the ability to cope with pain. Scores range from 0 to 52, with higher scores indicating increased pain catastrophizing.

  3. Mindfulness

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

    Applied Mindfulness Process Scale (AMPS); assesses mindfulness use in daily life. Scores range from 0 to 60, with higher scores indicating greater utilization of mindfulness.

  4. Current Status

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

    Measure of Current Status (MOCS); assesses healthy coping skills. Scores range from 0 to 52, with higher scores reflecting a stronger ability to recognize and cope with stress.

  5. Self-Compassion

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

    Self-Compassion Scale - Short Form (SCS-SF); assesses the ability to practice self-compassion. Scores range from 1 to 5, with higher scores associated with lower levels of self-compassion.

  6. Social Support

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

    Interpersonal Support Evaluation List - 12 (ISEL-12); measures perceptions of social support. Scores range from 12 to 48, with higher scores indicating stronger social support.

  7. Loneliness

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

    University of California Los Angeles - 3 Loneliness Scale (UCLA-3); measures loneliness in relational connectedness, social connectedness, and social isolation. Scores range from 3 to 9, with higher scores indicating greater social isolation.

  8. Fear of Pain

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

    Tampa Scale for Kinesiophobia - 11 (TSK-11); assesses fear of pain and activities that cause pain. Scores range from 11 to 44, with higher scores reflecting more severe kinesiophobia.

  9. Self-Efficacy for Exercise

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

    Self-Efficacy for Exercise (SEE); assesses an individual's beliefs in their ability to exercise three times per week for 20 minutes. Scores range from 0 to 90, with higher scores indicating higher confidence in exercising despite barriers.

  10. Post Traumatic Stress Disorder

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

    Abbreviated Post-Traumatic Checklist-Civilian Version (PCL-C-6); assess current Post Traumatic Stress Disorder (PTSD) symptoms. Scores range from 6 to 30, with higher scores being suggestive of greater difficulties with post-traumatic stress.

  11. Discrimination

    Time frame: Baseline

    Everyday Discrimination Scale - Short Version (EDS-S); assesses experiences of daily discrimination against minority populations. Scores range from 0 to 25, with higher scores indicating greater frequency of discriminatory experiences.

  12. Stress

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

    Perceived Stress Scale - 4 (PSS-4); assesses stress perception levels. Scores range from 0 to 16, with higher scores indicating more severe stress.

  13. Substance Use

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

    Tobacco, Alcohol, Prescription medications, and other Substance use (TAPS); assess substance use behaviors. Each substance is scored individually from 0 to 4, with lower scores indicating more problematic substance use behaviors.

  14. Sleep Duration

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

    1-item of the Pittsburgh Sleep Quality Index (PSQI); assesses average sleep duration per night in the past month.

  15. Sleep Disturbance

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

    PROMIS v1.0 Sleep Disturbance - Short Form 6a; assesses duration and quality of sleep. Scores range from 6 to 30, with greater scores indicating higher sleep quality and more sleep disturbance.

  16. Quality of Life Assessment

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

    World Health Organization Quality of Life - 2 (WHOQOL-2); assesses satisfaction with health and quality of life. Scores range from 2 to 10, with higher scores indicating greater quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana-Maria Vranceanu, PhD

CONTACT

[email protected]

617-724-4977

Christine Ritchie, MD, MPH

CONTACT

[email protected],

617-726-1382

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ vs Treatment as Usual; iHOPE Study

Acronym: iHOPE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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