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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: GetActive-Fitbit
* Behavioral: Healthy Living for Pain


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GetActive-Fitbit<br>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<br>* 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.<br>|
| Active Comparator: Healthy Living for Pain<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 
| 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 | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Physical Function, Mindfulness