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

NCT05700383 | Completed Results DMC

• 2 other identifiers: 2023P0003211R01AT012069-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Chronic Pain; Physical Function; Mindfulness

Outcome Measures

Primary Outcomes (9)

• Recruitment Feasibility (Ability)

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

  1 Year

• Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 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.

  1 Year

• Feasibility of Recruitment Racial and Ethnic Minorities

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

  1 Year

• Intervention Feasibility/ Adherence to Sessions

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

  Post-Test (10 Weeks)

• Credibility and Expectancy Scale - Credibility

  ≥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.

  Baseline (0 Weeks)

• Client Satisfaction Scale

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

  Post-Test (10 Weeks)

• Retention

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

  Post-test (10 weeks), Follow-up (24 weeks)

• Assessment Feasibility

  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.

  1 Year

• Credibility and Expectancy Questionnaire - Expectancy

  ≥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.

  Baseline (0 weeks)

Secondary Outcomes (11)

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

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

• WHO Disability Assessment Schedule 2.0 (WHODAS)

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

• 6 Minute Walk Test (6MWT)

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

• ActiGraph GT9X

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

• PROMIS Depression v1.08b

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

Study Arms (2)

GetActive-Fitbit

EXPERIMENTAL

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.

Behavioral: GetActive-Fitbit

Healthy Living for Pain

ACTIVE COMPARATOR

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.

Behavioral: Healthy Living for Pain

Interventions

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.

GetActive-Fitbit

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.

Healthy Living for Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Rush University Medical Center: collaborator
• Duke University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (3)

Rush Medical Center

Chicago, Illinois, 60612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• Greenberg J, Hooker JE, McDermott KA, La Camera DE, Brewer JR, Szapary CL, Somers TJ, Keefe F, Kelleher SA, Fisher HM, Burns J, Jeddi R, Kulich R, Polykoff GI, Parker RA, Vranceanu AM; THRIVE Study Team; Diachina A, Hogan S, Chou N, Yates L. Feasibility of a Mind-Body Program for Chronic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2515685. doi: 10.1001/jamanetworkopen.2025.15685.

  PMID: 40522662 DERIVED

• Hooker JE, Brewer JR, McDermott KA, Kanaya M, Somers TJ, Keefe F, Kelleher S, Fisher HM, Burns J, Jeddi RW, Kulich R, Polykoff G, Parker RA; THRIVE Study Team; Greenberg J, Vranceanu AM. Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT. Contemp Clin Trials. 2024 Mar;138:107462. doi: 10.1016/j.cct.2024.107462. Epub 2024 Jan 28.

  PMID: 38286223 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: April 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 28, 2026
• Results First Posted: July 16, 2025

Record last verified: 2026-01

Locations

US (3)