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Completed

NCT Number: NCT05700383

The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain

The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program compared to a health education program for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush Medical Center, Chicago, Illinois, United States

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About this study

The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program (GetActive-Fitbit) compared to a health education program (Healthy Living for Pain) for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person.

Each program will consist of ten 60-minute sessions in-person. Participants will receive a treatment manual and ActiGraph watch to assess physical function. There are 3 assessment points consisting of self-report surveys and performance-based measures: baseline, post-program, and 6-month follow-up. All participants will receive access to the other program's manual and website after completing the six-month follow-up.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female outpatients, age 18 years or older
  • Fluent in English
  • Have nonmalignant chronic musculoskeletal pain for more than 3 months
  • Able to perform a 6-minute walk test (6MWT)
  • Owns a smartphone with Bluetooth 4.0 or computer
  • Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol.
  • Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
  • Low-level of activity (must meet 2/3 criteria; if difficult to assess, recruiter may ask participant to report their recent step data from their smartphone to better understand their activity level)
  • Sitting for more than 8 hours/day per self-report
  • Exercising for fewer than 3 days/week (30+min of exercise constitutes an "exercise day") per self-report
  • Walking for fewer than 7 days/week (30+min of walking constitutes a "walking day") per self-report

Exclusion criteria

  • Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
  • Serious mental illness or instability for which hospitalization may be likely in the next 6 months
  • Current active suicidal ideation reported on self-report
  • Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder
  • Current, active substance abuse or dependence, and current alcohol dependence within the past 6 months
  • Practice of yoga, meditation, guided imagery or other mind body techniques that elicit the RR, once per week for >45 min 3 times/week within the last 3 months or less.
  • Regular use of Fitbit DMD in the last 3 months
  • Unable to walk/in a wheelchair
  • Mild cognitive decline for participants 65+ only (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors).

Treatment and study plan

GetActive-Fitbit

Behavioral

GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking.

Healthy Living for Pain

Behavioral

Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling.

Primary outcomes

  1. Recruitment Feasibility (Ability)

    Time frame: 1 Year

    Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.

  2. Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year

    Time frame: 1 Year

    Timeliness of enrollment; we will recruit a sample of 90 patients across the 3 sites over the course of 1 year. Participants will be considered enrolled upon randomization. Assessed by the number of participants enrolled in the study over the course of 1 year. If number enrolled meets or exceeds goal of 90 participants, the benchmark is considered met.

  3. Feasibility of Recruitment Racial and Ethnic Minorities

    Time frame: 1 Year

    38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution.

  4. Intervention Feasibility/ Adherence to Sessions

    Time frame: Post-Test (10 Weeks)

    ≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)

  5. Credibility and Expectancy Scale - Credibility

    Time frame: Baseline (0 Weeks)

    ≥80 chronic pain patients with credibility scores higher than the Credibility and Expectancy Scale credibility subscale's mid-point, indicating intervention credibility. Credibility subscale scores range from 3 to 27. Higher scores indicate higher perceived credibility for the program.

  6. Client Satisfaction Scale

    Time frame: Post-Test (10 Weeks)

    ≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction.

  7. Retention

    Time frame: Post-test (10 weeks), Follow-up (24 weeks)

    ≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants).

  8. Assessment Feasibility

    Time frame: 1 Year

    We calculated the proportion of assessment procedures that were administered as intended in the the checklists of the study protocol. The number of assessment procedures that were administered in line with the study's protocol checklists was divided by the total number of assessment procedures. The benchmark was set to 90%, i.e., assessment procedures were deemed feasible if ≥90% of assessment procedures were delivered as specified in the protocol.

  9. Credibility and Expectancy Questionnaire - Expectancy

    Time frame: Baseline (0 weeks)

    ≥80 chronic pain patients with expectancy scores higher than the subscale's mid-point, indicating intervention expectancy. Expectancy subscale scores range from 3 to 27. Higher scores indicate more belief that treatment will help.

Secondary outcomes

  1. Pain, Enjoyment of Life and General Activity (PEG-3) Scale

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    Rate of a participant's pain intensity and related interference in enjoyment of life and general activity, using a 0-10 Likert scale. Scores range from 0-30 with higher scores indicating greater pain and interference.

  2. WHO Disability Assessment Schedule 2.0 (WHODAS)

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each question on the scale is measured 0-4. The score range is 0-100, with higher scores indicating more disability.

  3. 6 Minute Walk Test (6MWT)

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    The 6MWT is a performance-based measure that assesses physical function and endurance.

  4. ActiGraph GT9X

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    The ActiGraph GT9X is a step count device that objectively measures function (number of steps).

  5. PROMIS Depression v1.08b

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    The PROMIS depression v1.08b measures negative mood, views of self and cognitions on a 5-point scale. Raw scores are converted into a t-score with a mean of 50 and standard deviation of 10. Higher scores indicate more depressive symptoms.

  6. PROMIS Anxiety v1.08a

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    The PROMIS anxiety v1.08a measures fear, worry, hyperarousal and somatic symptoms. Each item is rated on a 1-5 point Likert Scale and raw scores are converted to t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicating more anxiety symptoms.

  7. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Higher scores indicate higher pain catastrophizing. Scores range from 0 to 52.

  8. Tampa Kinesiophobia Scale (TSK)

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia. Scores range from 17 to 68.

  9. Measure of Current Status (MOCS)

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    The MOCS questionnaire assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Higher scores indicate a stronger ability to recognize stress and cope, with scores ranging from 10 to 50.

  10. Cognitive and Affective Mindfulness Scale (CAMS)

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    Rate of a participant's broad conceptualization of mindfulness, items range from 1-4. Higher values reflect higher levels of mindfulness. Scores range from 12 to 48.

  11. Modified Global Impression of Change (MGIC)

    Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

    3-items assessing the extent to which patients perceive the intervention improved functioning and symptoms. Each item is rated on a 1-7 point scale with higher scores indicated greater perceived improvement.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Duke University
  • National Center for Complementary and Integrative Health (NCCIH)
  • Rush University Medical Center

Registry information

Official study title

The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain: Multi-site Feasibility RCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2023
Registry last updated
Jan 28, 2026

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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