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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: GetActive-Fitbit; Behavioral: Healthy Living for Pain

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Greenberg, PhD; Phone Number: 617-643-9402; Email: jgreenberg5@mgh.harvard.edu
• Study Contact Backup: Name: Ana-Maria Vranceanu, PhD; Phone Number: 617-724-4977; Email: avranceanu@mgh.harvard.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male and female outpatients, age 18 years or older
2. Fluent in English
3. Have nonmalignant chronic musculoskeletal pain for more than 3 months
4. Able to perform a 6-minute walk test (6MWT)
5. Owns a smartphone with Bluetooth 4.0 or computer
6. Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol.
7. 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

8. 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)

   1. Sitting for more than 8 hours/day per self-report
   2. Exercising for fewer than 3 days/week (30+min of exercise constitutes an "exercise day") per self-report
   3. Walking for fewer than 7 days/week (30+min of walking constitutes a "walking day") per self-report

Exclusion Criteria:

1. Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
2. Serious mental illness or instability for which hospitalization may be likely in the next 6 months
3. Current active suicidal ideation reported on self-report
4. Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder
5. Current, active substance abuse or dependence, and current alcohol dependence within the past 6 months
6. 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.
7. Regular use of Fitbit DMD in the last 3 months
8. Unable to walk/in a wheelchair
9. Mild cognitive decline for participants 65+ only (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GetActive-Fitbit; 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; 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.
Active Comparator: Healthy Living for Pain; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment feasibility (ability)	Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.	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	≥80 chronic pain patients with credibility scores higher than the scale's mid point, indicating intervention credibility	Baseline (0 Weeks)
Client Satisfaction Scale	≥80 chronic pain patients with credibility 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).	1 Year
Assessment feasibility	≥90 accuracy of standardized protocol checklists for all assessments.	1 Year
Recruitment feasibility (timeliness)	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 attending Session 1.	1 Year
Adherence to Accelerometer	Daily wear of charged ActiGraph GT9X for GetActive-Fitbit Daily wear of Actigraph accelerometer for baseline and follow-up assessments.	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, Enjoyment of Life and General Activity (PEG-3) Scale	Rate of a participant's pain intensity and related interference in enjoyment of life and general activity, using a 0-10 Likert scale	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
WHO Disability Assessment Schedule 2.0 (WHODAS)	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, with higher scores indicating more disability.	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
6 Minute Walk Test (6MWT)	The 6MWT is a performance-based measure that assesses physical function and endurance.	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
ActiGraph GT9X	The ActiGraph GT9X is a step count device that objectively measures function (number of steps).	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
PROMIS depression v1.08b	The PROMIS depression v1.08b measures negative mood, views of self and cognitions on a 5-point scale, with higher scores indicating more depressive symptoms	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
PROMIS anxiety v1.08a	The PROMIS anxiety v1.08a measures fear, worry, hyperarousal and somatic symptoms, with higher scores indicating more anxiety symptoms	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Pain Catastrophizing Scale (PCS)	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	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Tampa Kinesiophobia Scale (TSK)	A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Measure of Current Status (MOCS)	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	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Cognitive and Affective Mindfulness Scale (CAMS)	Rate of a participant's broad conceptualization of mindfulness, items range from 1-4. Higher values reflect higher levels of mindfulness	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Modified Global Impression of Change (MGIC)	2-item assessing the extent to which patients perceive the intervention improved functioning and symptoms.	Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Duke University; Rush University Medical Center; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Pain; Mindfulness; Physical Function
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2023P000321; 1R01AT012069-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No